Effects of nurse-led home-based exercise & cognitive behavioral therapy on reducing cancer-related fatigue in patients with ovarian cancer during and after chemotherapy: A randomized controlled trial

BackgroundHigh levels of fatigue have been documented in ovarian cancer patients. However, increased levels of fatigue are positively associated with a high risk of sleep disturbance and depression.ObjectiveTo investigate the feasibility of a nurse-led home-based exercise and cognitive behavioral therapy (E&CBT) for ovarian cancer adults with cancer-related fatigue on outcomes of fatigue, plus other secondary outcomes (sleep disturbance and depression), either during or after completion of primary cancer treatment.DesignRandomized, single-blind control trial.SettingsGynaecologic oncology department of the First Hospital of Jilin University in China.Participants72 eligible women who recently had surgery and completed their first cycle of adjuvant chemotherapy were randomly assigned to two groups.InterventionThe experimental group received exercise and cognitive behavioral therapy. Five nurses with nursing master degree were trained to deliver this intervention. Patients received online interventions each week in the patient's place of residence or in the nurse-led clinic, as requested. Home visits, coupled with telephone-based motivational interviews twice a week were available with the permission of the participants. comparison group participants received services as usual.MeasurementsThe primary outcome was measured by the Chinese version of the Piper Fatigue Scale that has 4 subscales (Behavior, Affect, Sensory, and Cognition). Secondary outcomes were measured using the Self-Rating Depression Scale and the Pittsburgh Sleep Quality Index questionnaire. Repeated-measure ANOVA was used to examine the effectiveness of this intervention in reducing fatigue, depression, and improving sleep quality.ResultsFor baseline comparisons, no significant differences were found between the two groups. After the interventions, total fatigue scores were significantly reduced from T1 to T2, to T3 in the experimental group (4.37, 4.24, 3.90), respectively. The comparison group showed almost no change in total fatigue score over time. In the repeated measures ANOVA, the differences of behavioral fatigue score (F = 11.647, p = 0.001) and cognitive fatigue score (F = 5.741, p = 0.019) were statistically significant for the group by time interaction. After the interventions, the experimental group participants demonstrated significantly lower symptoms of depression compared with the comparison group (T2: p = 0.001 and T3: p < 0.001). Sleep duration, sleep dysfunction, daytime dysfunction as well as total sleep quality significantly improved.ConclusionNurse-delivered home-based E&CBT have measurable benefits in helping women with ovarian cancer to decrease cancer-related fatigue, depressive symptoms, and improving their quality of sleep.     

A nurse facilitated mind-body interactive exercise (Chan-Chuang qigong) improves the health status of non-Hodgkin lymphoma patients receiving chemotherapy: Randomised controlled trial

BackgroundNon-Hodgkin’s lymphoma is a heterogeneous group of lymphoproliferative malignancies. Chemotherapy can improve patient survival rates, yet it is also associated with many adverse physical and psychosocial effects. It is suggested that qigong practices may be used to reduce patient distress and side effects.ObjectivesTo evaluate the effects of Chan-Chuang qigong on fatigue, complete blood cells, sleep quality, and quality of life for patients with non-Hodgkin lymphoma who had undergone the first course of chemotherapy.DesignA randomized controlled study.SettingsAn oncology ward of medical centre in northern Taiwan.ParticipantsFifty participants in each of the two groups.MethodsParticipants were randomly assigned to either the qigong group (n = 50) that received a 21-day Chan-Chuang qigong programme, or the control group (n = 50). The primary outcome was fatigue measured by Brief Fatigue Inventory. The secondary outcomes were complete blood cell counts, sleep quality measured by Verran and Snyder-Halpern Sleep Scale, and quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.ResultsAfter 21 days of intervention, the results obtained from ninety six participants were analysed. Participants in the qigong group exhibited decreased fatigue intensity and fatigue interference from 5.49 (SD = 1.02) and 5.53 (SD = 1.27) to 0.37 (SD = 1.39) and 0.20 (SD = 1.93), respectively. Generalized estimating equations analyses revealed that the qigong group, when compared to the control group, had significant improvement in fatigue intensity and fatigue interference over time (β = −1.04, 95% confidence interval [CI] from −1.59 to −0.48, p < 0.001; and β = −1.22, 95% CI from −1.86 to −0.59, p < 0.001, respectively). There was a significant between-group difference in the improvement in white blood cell counts (t = 5.14, p < 0.001), hemoglobin levels (t = 3.17, p = 0.002), and sleep quality (t = 17.73, p < 0.001), but not in platelet counts (p = 0.05). With regard to quality of life, the scores of the qigong group improved in all subscales and all symptom items when compared to that of the control group. No adverse effects were observed in the qigong group.ConclusionsThe findings of this study indicate that the 21-day Chan- Chuang qigong can reduce fatigue intensity and fatigue interference, and improved white blood cell counts, haemoglobin levels, sleep quality, and quality of life for patients with non-Hodgkin lymphoma who had undergone the first course of chemotherapy. Further studies involving a prolonged extended intervention period and follow-up are necessary for determining the long-term effect of qigong exercise.     

A Home-Based Exercise Program to Improve Function,Fatigue, and Sleep Quality in Patients With Stage IV Lung and Colorectal Cancer: A Randomized Controlled Trial

ContextExercise benefits patients with cancer, but studies of home-based approaches, particularly among those with Stage IV disease, remain small and exploratory.ObjectivesTo conduct an adequately powered trial of a home-based exercise intervention that can be facilely integrated into established delivery and reimbursement structures.MethodsSixty-six adults with Stage IV lung or colorectal cancer were randomized, in an eight-week trial, to usual care or incremental walking and home-based strength training. The exercising participants were instructed during a single physiotherapy visit and subsequently exercised four days or more per week; training and step-count goals were advanced during bimonthly telephone calls. The primary outcome measure was mobility assessed with the Ambulatory Post Acute Care Basic Mobility Short Form. Secondary outcomes included ratings of pain and sleep quality as well as the ability to perform daily activities (Ambulatory Post Acute Care Daily Activities Short Form), quality of life (Functional Assessment of Cancer Therapy-General), and fatigue (Functional Assessment of Cancer Therapy-Fatigue).ResultsThree participants dropped out and seven died (five in the intervention and two in the control group, P = 0.28). At Week 8, the intervention group reported improved mobility (P = 0.01), fatigue (P = 0.02), and sleep quality (P = 0.05) compared with the usual care group, but did not differ on the other measures.ConclusionA home-based exercise program seems capable of improving the mobility, fatigue, and sleep quality of patients with Stage IV lung and colorectal cancer.     

Armodafinil for Sarcoidosis-Associated Fatigue: A Double-Blind,Placebo-Controlled,Crossover Trial

ContextFatigue has been identified in more than one-half of patients with sarcoidosis. Although fatigue is not synonymous with impaired quality of life, most studies of sarcoidosis identify fatigue as a major cause of impaired quality of life.ObjectivesTo test the hypothesis that stimulants may have a role in the treatment of fatigued sarcoidosis patients, even without objective evidence of daytime sleepiness.MethodsThis was a double-blind, placebo-controlled, crossover study of sarcoidosis patients followed up in one sarcoidosis clinic Sarcoidosis patients with fatigue received either armodafinil or placebo with eight weeks of therapy for each arm and a two week washout period before crossover to the other treatment. Initial armodafinil dose was 150 mg and increased to 250 mg after four weeks. Patients underwent polysomnography and multiple sleep latency testing (MSLT) the following day. Patients with an apnea/hypopnea index <6/hour received either armodafinil or placebo. Polysomnography with MSLT was repeated after each treatment arm.ResultsFifteen patients received the study drug. Fatigue was assessed using the Fatigue Assessment Scale (the lower the score, the less the fatigue) and the Functional Assessment of Chronic Illness Therapy—Fatigue (FACIT-F) (the higher the score, the less the fatigue). After eight weeks of therapy, there was a significant improvement in the Fatigue Assessment Scale during armodafinil treatment (median ?4.5, range ?20, 5) compared with placebo treatment (median 3.5, range ?9, 14, P < 0.05) and for the FACIT-F (armodafinil: median 9, range ?12, 26 vs. placebo: median ?5, range ?17, 11, P < 0.005). This improvement in fatigue was seen for both those with and without shortened sleep onset latency time during the MSLT.ConclusionArmodafinil treatment led to a significant reduction in fatigue in sarcoidosis patients. This effect was seen even in patients who did not have excessive daytime somnolence.     

Comparisons of exercise dose and symptom severity between exercisers and nonexercisers in women during and after cancer treatment

ContextAlthough numerous studies of the efficacy of exercise are reported, few studies have evaluated changes in characteristics of exercise dose in women with cancer both during and after cancer treatment.ObjectivesTo describe the characteristics of exercise dose (i.e., frequency, duration, and intensity) and evaluate for differences in symptom severity (i.e., fatigue, sleep disturbance, depression, and pain) between women who did and did not exercise during and after cancer treatment.MethodsIn a sample of 119 women, two groups were classified: exercisers and nonexercisers. Exercisers were defined as women who met specific criteria for frequency (three times per week), duration (20 minutes/session), intensity (moderate), and mode (aerobic). Nonexercisers were defined as women who did not meet all these criteria. Evaluation of exercise dose was completed at baseline (T1: the week before chemotherapy cycle 2), at the end of cancer treatment (T2), and at the end of the study (T3: approximately one year after the T1 assessment) using self-report exercise questionnaires.ResultsApproximately 50% of the participants exercised during treatment and 70% exercised after treatment. At T1, exercisers had lower total fatigue, lower behavioral and sensory subscale fatigue scores, and lower depression scores (P = 0.038) than nonexercisers. No significant differences in sleep disturbance or pain were found between groups. At T2, exercisers had lower cognitive/mood subscale fatigue and depression scores than nonexercisers (P = 0.047). At T3, no significant differences were found between groups in any symptom severity scores.ConclusionBoth during and after cancer treatment, achieving or maintaining exercise guideline levels were met by most patients. Further study is needed to examine the link between exercise dose and symptom severity.     

Exercises improve body composition,cardiovascular risk factors and bone mineral density for menopausal women: A systematic review and meta-analysis of randomized controlled trials

BackgroundMenopause has been considered as an aggravating factor for developing cardiovascular diseases and the metabolic syndromes for women. Exercise might be an effective intervention for reducing such threats.ObjectiveThe purpose of this study was to evaluate the exercise effects on body composition, cardiovascular risk factors, and bone mineral density of menopausal women.MethodsTwo reviewers did a complete search of five electronic database (Medline, PubMed, Cochrane Central Register of Controlled Trials, CINAHL, and the Chinese Electronic Periodical Service) records up to January 31, 2014. Randomized controlled trials (RCTs) that compared female menopausal participants with exercises, and those without exercise or with placebo were included. Risk of bias was classified based on the Cochrane Collaboration tool, the meta-analysis was conducted using Comprehensive Meta-Analysis Version 2.2. The study selection, data extraction, and validation were performed independently by the 2 reviewers.ResultsA total of 17 RCTs with 792 participants were included for meta-analysis. Among the eight RCTs (247 participants), a moderate effect size of exercise on body fat was found (SMD = − 0.34, 95% CI: − 0.60 to − 0.08). In five RCTs (195 participants), a moderate effect size of exercise on waist circumference (SMD = − 0.39, 95% CI: − 0.68 to − 0.09), in seven RCTs (162 participants), a moderate effect size on triglyceride level (SMD = − 0.37, 95% CI: − 0.62 to − 0.11), and in five RCTs (311 participants), a moderate effect size on bone mineral density (SMD = 0.38, 95% CI: 0.08–0.68). Subgroup analysis revealed a significant effect of aerobic exercise on body fat (SMD = − 0.29, 95% CI: − 0.53 to − 0.06), and a short-term exercise on body fat (SMD = − 0.50, 95% CI: − 0.89 to − 0.11) and on triglycerides (SMD = − 0.42, 95% CI: − 0.79 to − 0.04). The trials included in this meta-analysis were small and some had methodologic limitations.ConclusionsThis study provides evidences to clinical practice for menopause women that exercise, compared with nonexercise or placebo exerted significant benefits on body fat, waist circumference, triglyceride level, and lumbar spine bone mineral density. Particularly, aerobic exercise did help menopausal women improve their body fat. A short-term exercise intervention had a benefit on not only body fat but also triglyceride level. However, well-designed, well-executed RCTs, and a detailed long-term clinical research should be needed in the future.     

Experimental protocol of a randomized controlled clinical trial investigating exercise,subclinical atherosclerosis,and walking mobility in persons with multiple sclerosis

BackgroundThis randomized controlled trial (RCT) will investigate the effects of a home-based aerobic exercise training regimen (i.e., cycle ergometry) on subclinical atherosclerosis and walking mobility in persons with multiple sclerosis (MS) and minimal disability.Methods/designThis RCT will recruit 54 men and women who have an Expanded Disability Status Scale characteristic of the 1st stage of MS (i.e., 0–4.0) to participate in a 3 month exercise or stretching intervention, with assessments of subclinical atherosclerosis and walking mobility conducted at baseline, week 6 (midpoint), and week 12 (conclusion) of the program. The exercise intervention will consist of 3 days/week of cycling, with a gradual increase of duration followed by an increase in intensity across the 3 month period. The attention-control condition will incorporate stretching activities and will require the same contact time commitment as the exercise condition. Both study groups will participate in weekly video chat sessions with study personnel in order to monitor and track program adherence. Primary outcomes will consist of assessments of vascular structure and function, as well as several walking tasks. Additional outcomes will include questionnaires, cardiorespiratory fitness assessment, and a 1-week free-living physical activity assessment.DiscussionThis investigation will increase understanding of the role of aerobic exercise as part of a treatment plan for managing subclinical atherosclerosis and improving walking mobility persons in the 1st stage of MS. Overall, this study design has the potential to lead to effective aerobic exercise intervention strategies for this population and improve program adherence.     

Cross-sectional and longitudinal associations between sleep and health-related quality of life in pregnant women: A prospective observational study

BackgroundSleep disturbances are common in women, especially during pregnancy. Previous studies have confirmed the importance of sleep disturbances as a risk factor of adverse pregnancy outcomes and the need for screening and treatment of inadequate sleep. These reports, however, did not examine health-related quality of life which may be affected by sleep long before adverse clinical consequences are detectable in women during pregnancy.ObjectivesTo examine the cross-sectional and longitudinal association between sleep and health-related quality of life in pregnant women.DesignA prospective observational study.SettingA university-affiliated hospital in Taiwan and participants’ homes.ParticipantsA total of 164 pregnant women completed questionnaires and wore a wrist actigraphy monitor for 7 days each trimester.MethodsObjective sleep was measured by actigraphy, subjective sleep was measured by the Pittsburgh Sleep Quality Index, and health-related quality of life was measured using the SF-12v2 questionnaire across three trimesters. Multiple linear regression analyses were performed to evaluate the cross-sectional and longitudinal associations between sleep and health-related quality of life.ResultsSixty-four (39.0%) women consistently had an average sleep efficiency < 85% by actigraphy and 40 (24.4%) had a Pittsburgh Sleep Quality Index global score > 5 in all three trimesters. Cross-sectionally, more actigraphic daytime sleep (p = 0.04) and better subjective sleep quality (p < 0.01) were associated with better physical health-related quality of life in first-trimester pregnant women. Better actigraphic sleep efficiency (p = 0.04) and better subjective sleep quality (p < 0.01) were associated with better mental health-related quality of life in second-trimester pregnant women. Longer actigraphic total nighttime sleep (p < 0.01) and better subjective sleep quality (p < 0.01) were associated with better mental health-related quality of life in third-trimester pregnant women. Longitudinally, first-trimester actigraphic total nighttime sleep (p < 0.05) and subjective sleep quality (p < 0.01) predicted mental health-related quality of life in the second and third trimester.ConclusionsSleep disturbances are a highly prevalent and persistent problem in pregnant women. Adequate sleep is essential for women at all pregnancy stages and improving nocturnal sleep quantity and quality in early gestation is of utmost importance for an optimal health-related quality of life later in pregnancy.     

Effect of low-impact aerobic exercise combined with music therapy on patients with fibromyalgia. A pilot study

ObjectiveFibromyalgia is a pathological entity characterized by chronic widespread musculoskeletal pain and the presence of “tender points”. It constitutes a significant health problem because of its prevalence and economic impact. The aim of the present study was to determine the therapeutic benefits of low impact aerobic exercise alone or in combination with music therapy in patients with fibromyalgia.MethodsA single-blind randomized controlled pilot trial was performed. Thirty-five individuals with fibromyalgia were divided into three groups: (G1) therapeutic aerobic exercise with music therapy (n = 13); (G2) therapeutic aerobic exercise at any rhythm (n = 13) and (CG) control (n = 9). The intervention period lasted eight weeks. Depression, quality of life, general discomfort and balance were assessed before and after intervention.ResultsAt post-intervention, group G1 improved in all variables (depression (p = 0.002), quality of life (p = 0.017), general discomfort (p = 0.001), and balance (p = 0.000)), while group G2 improved in general discomfort (p = 0.002). The change observed in balance was statistically different between groups (p = 0.01).ConclusionTherapeutic aerobic exercise is effective in improving depression and general discomfort in individuals with fibromyalgia. However, effectiveness is higher when combined with music therapy, which brings about further improvements in quality of life and balance.     

A yoga & exercise randomized controlled trial for vasomotor symptoms: Effects on heart rate variability

ObjectivesHeart rate variability (HRV) reflects the integration of the parasympathetic nervous system with the rest of the body. Studies on the effects of yoga and exercise on HRV have been mixed but suggest that exercise increases HRV. We conducted a secondary analysis of the effect of yoga and exercise on HRV based on a randomized clinical trial of treatments for vasomotor symptoms in peri/post-menopausal women.DesignRandomized clinical trial of behavioral interventions in women with vasomotor symptoms (n = 335), 40–62 years old from three clinical study sites.Interventions12-weeks of a yoga program, designed specifically for mid-life women, or a supervised aerobic exercise-training program with specific intensity and energy expenditure goals, compared to a usual activity group.Main outcome measuresTime and frequency domain HRV measured at baseline and at 12 weeks for 15 min using Holter monitors.ResultsWomen had a median of 7.6 vasomotor symptoms per 24 h. Time and frequency domain HRV measures did not change significantly in either of the intervention groups compared to the change in the usual activity group. HRV results did not differ when the analyses were restricted to post-menopausal women.ConclusionsAlthough yoga and exercise have been shown to increase parasympathetic-mediated HRV in other populations, neither intervention increased HRV in middle-aged women with vasomotor symptoms. Mixed results in previous research may be due to sample differences. Yoga and exercise likely improve short-term health in middle-aged women through mechanisms other than HRV.     

Extracorporeal shock wave therapy for treating dyspareunia: A prospective,randomized, double-blind,placebo-controlled study

BackgroundDyspareunia is a genital pain during or after penile-vaginal sexual intercourse. It is a painful spasm of the pelvic muscles that partly or entirely disables vaginal penetration.ObjectivesWe examined the effect of extracorporeal shock wave therapy (ESWT) on idiopathic non-organic dyspareunia in women. A prospective, randomized, double-blind, placebo-controlled study was conducted.MethodsThe study included 62 women who reported dyspareunia. Patients in the treatment and placebo groups received ESWT perineally weekly for 4 consecutive weeks; placebo patients received placebo stand-off treatment. The grade of dyspareunia was estimated by using the Marinoff Dyspareunia Scale and subjective pain intensity on a visual analog scale (VAS) before and after treatment. Follow-ups were conducted 1, 4 and 12 weeks after the final ESWT session.ResultsThe study included 61 women. The treatment but not placebo group differed by the Marinoff Dyspareunia Scale and VAS. Differences before and after treatment within groups were all P < 0.001 and between groups, P < 0.001. Pain reduction was always > 30%. The effect sizes were both large: Marinoff 0.825 and VAS 0.883.ConclusionsESWT significantly reduced subjective pain in our women treated for dyspareunia.     

Activating brown adipose tissue through exercise (ACTIBATE) in young adults: Rationale,design and methodology

AimsThe energy expenditure capacity of brown adipose tissue (BAT) makes it an attractive target as a therapy against obesity and type 2 diabetes. BAT activators namely catecholamines, natriuretic peptides and certain myokines, are secreted in response to exercise. ACTIBATE will determine the effect of exercise on BAT activity and mass measured by positron emission tomography/computed tomography (PET/CT, primary outcome) in young adults. ACTIBATE will also investigate the physiological consequences of activating BAT (secondary outcomes).MethodsACTIBATE will recruit 150 sedentary, healthy, young adults (50% women) aged 18–25 years. Eligible participants will be randomly assigned to a non-exercise group (n ≈ 50) or one of two exercise groups (n = 50 each). Participants in the exercise groups will perform aerobic and strength training 3–4 days/week at a heart rate equivalent to 60% of heart rate reserve (HRres), and at 50% of 1 repetition maximum (RM) for the moderate-intensity group, and at 80% of HRres and 70% RM for the vigorous-intensity group. Laboratory measures completed at baseline and 6 months include BAT activity and mass, resting energy expenditure, meal and cold-induced thermogenesis, body temperature regulation and shivering threshold, body composition and cardiovascular disease risk factors. We will also obtain biopsies from abdominal subcutaneous white adipose tissue and skeletal muscle to analyse the expression of genes encoding proteins involved in the thermogenic machinery.DiscussionFindings from ACTIBATE will have significant implications for our understanding of exercise and its protective effects against the development of type 2 diabetes, obesity and related metabolic diseases.ClinicalTrials.gov ID: NCT02365129     

The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: protocol of the EFIGRO study

BackgroundNon-alcoholic fatty liver disease is the most frequent liver abnormality observed in overweight or obese children and is strongly associated with metabolic syndrome and insulin resistance.Objectives(i) To evaluate the effect of a 22-week multidisciplinary intervention program on hepatic fat fraction in overweight or obese children and (ii) to examine the effect of the intervention on cardiometabolic risk factors, self-esteem and well-being.MethodsA total of 160 children, 9–11 years, will be recruited by pediatricians and randomly assigned to control (N = 80) or intervention (N = 80) groups. The control group will receive a family-based lifestyle and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week). The duration of training sessions will be 90 min of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises. The primary outcome is the change in hepatic fat fraction (magnetic resonance imaging, MRI). Secondary outcomes include cardiometabolic risk factors such as total adiposity (dual X-ray absorptiometry), visceral adiposity (MRI), functional peak aerobic capacity (cardiopulmonary exercise testing), blood pressure, muscular fitness, speed–agility, and fasting blood insulin, glucose, C-reactive protein, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, lipid profile and psychological measurements (questionnaires). All the measurements will be evaluated at baseline prior to randomization and after the intervention.DiscussionThis study will provide insight in the efficacy of a multidisciplinary intervention program including healthy lifestyle education, psycho-education and supervised exercise to reduce hepatic fat and cardiometabolic risk in overweight children.     

Effects of endurance and endurance–strength exercise on biochemical parameters of liver function in women with abdominal obesity

IntroductionObesity is a risk factor of nonalcoholic fatty liver disease. Although the standard therapy for obesity involves physical exercise, well-planned studies of the changes in liver function in response to different exercise intensities in obese subjects are scarce. The aim of the present study was to examine a question of how does exercise mode affect the liver function.Material and methods44 women with abdominal obesity were randomized into two exercise groups: endurance (group A) and endurance-strength (group B). Women in each group exercised for 60 min 3 times/week for a 3-month period. Markers of liver function: serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyltranspeptidase (GGT), alkaline phosphatase (ALP) activities, and bilirubin levels were quantified.ResultsWe found significant differences in ALT (p < 0.01) and AST (p < 0.05) activities between group A and B after training exercise. Blood ALT and AST tended to decrease in group B, increase in group A. Significant reduction in serum GGT level after exercise in both groups was observed (p < 0.001, group A; p < 0.01, group B). Neither endurance nor endurance-strength exercise led to changes in serum ALP activity and total or direct bilirubin level. However, endurance-strength training resulted in significant decreases in serum indirect bilirubin (p < 0.05). Strong positive correlations between serum indirect bilirubin and body mass (r = 0.615; p = 0.0085) and BMI (r = 0.576; p = 0.0154) were found after endurance-strength exercise (group B).ConclusionThe mode of exercise does matter: endurance-strength exercise led to a greater improvement, compared to endurance exercise, in the liver function in women with abdominal obesity.     

The Vitality,Independence, and Vigor in the Elderly 2 Study (VIVE2): Design and methods

BackgroundNutritional supplementation may potentiate the increase in skeletal muscle protein synthesis following exercise in healthy older individuals. Whether exercise and nutrition act synergistically to produce sustained changes in physical functioning and body composition has not been well studied, particularly in mobility-limited older adults.MethodsThe VIVE2 study was a multi-center, randomized controlled trial, conducted in the United States and Sweden. This study was designed to compare the effects of a 6-month intervention with a once daily, experimental, 4 fl. oz. liquid nutritional supplement providing 150 kcal, whey protein (20 g), and vitamin D (800 IU) (Nestlé Health Science, Vevey, Switzerland), to a low calorie placebo drink (30 kcal, non-nutritive; identical format) when combined with group-based exercise in 150 community-dwelling, mobility-limited older adults. All participants participated in a structured exercise program (3 sessions/week for 6 months), which included aerobic, strength, flexibility, and balance exercises.ResultsThe primary outcome was 6-month change in 400 m walk performance (m/s) between supplement and placebo groups. Secondary outcomes included 6 month change in: body composition, muscle cross-sectional area, leg strength, grip strength, stair climb time, quality of life, physical performance, mood/depressive symptoms and nutritional status. These outcomes were selected based on their applicability to the health and well-being of older adults.ConclusionsThe results of this study will further define the role of nutritional supplementation on physical functioning and restoration of skeletal muscle mass in older adults. Additionally, these results will help refine the current physical activity and nutritional recommendations for mobility-limited older adults.     

Prevalence and patterns of subclinical motor and cognitive impairments in non-disabled individuals with early multiple sclerosis: A multicenter cross-sectional study

BackgroundMotor and cognitive disorders appear early in the course of multiple sclerosis (MS) and develop gradually over time.ObjectiveTo study the frequency and pattern of subtle functional disorders in people with MS (PwMS) with no overt signs of disability in an early phase of the disease and their association with walking impairments in daily activities.MethodsIn this cross-sectional study, we recruited PwMS with an Expanded Disability Status Scale (EDSS) score ≤ 2.5 and disease duration ≤ 5 years. Participants were assessed with functional scales rating walking endurance (6-Min Walk Test), perceived walking ability (Twelve-item Multiple Sclerosis Walking Scale), balance (Fullerton Advanced Balance scale_short), manual dexterity (Nine Hole Peg Test), fatigue (Fatigue Severity Scale), and cognitive impairments (Brief International Cognitive Assessment).ResultsAbout 90% of the 82 PwMS (mean [SD] EDSS score 1.5 [0.7] and disease duration 2.2 [1.7] years) showed endurance values below the expected score; almost 30% showed impairment, and for 57%, perceived walking ability score was abnormal. Balance was impaired in 48% of participants, as was manual dexterity (29%) and fatigue (24%), but only a few showed cognitive impairments. Only 11% of PwMS had no abnormal score on the scales used in the assessment. As compared with EDSS score 0 to 1.5, with EDSS score 2 to 2.5, performance was worse for endurance (difference ± 61.0 m, P = 0.016), perceived walking ability (?11 points, P = 0.002), balance (+1.9 points, P = 0.005), manual dexterity (?2.8 s, P = 0.004), and fatigue (?1.3 points, P = 0.013). Factors that predicted perceived walking ability were balance (B = ?1.37, P < 0.001) and fatigue (B = 5.11, P < 0.001) rather than endurance (B = ?0.01, P = 048).ConclusionEven PwMS with no clinical disability and classified as having “no problem walking” present walking and other functional deficits when assessed with specific functional tests. The addition of specific tools could better identify subtle motor and cognitive deficits. Finally, the assessment of balance disorders and fatigue is important to understand individuals’ perceived walking impairments in daily activities.     

Impact of a Palliative Care Consultation Team on Cancer-Related Symptoms in Advanced Cancer Patients Referred to an Outpatient Supportive Care Clinic

ContextPatients with advanced cancer may develop severe physical and psychosocial symptoms. There are limited data on the impact of an outpatient palliative consultation (PC) team on cancer-related symptoms.ObjectivesTo study the impact of the PC on symptoms in patients with advanced cancer receiving outpatient palliative care.MethodsFour hundred six consecutive patients referred to a supportive care outpatient center (OPC) from January 2006 to June 2007 with complete Edmonton Symptom Assessment Scale (0–10 scale) at the initial and follow-up visits were reviewed. Patient characteristics, change of symptoms at follow-up visit, and response rate were analyzed. Using logistic regression models, the predictors of improvement of pain and fatigue were assessed.ResultsMedian age was 59 years; 53% were female. Median interval between visits was 15 days. Mean scores at baseline and follow-up visits were fatigue 6.8 and 5.3 (P < 0.0001), pain 5.3 and 4.1 (P < 0.0001), depression 3.2 and 2.5 (P < 0.0001), anxiety 3.7 and 2.8 (P < 0.0001), dyspnea 2.7 and 2.5 (P = 0.05), sleep 5 and 4 (P < 0.0001), and well-being 5.2 and 4.4 (P < 0.0001). Dyspnea (odds ratio and P-value, 0.90, 0.03), nausea (0.92, 0.06), and depression (0.91, 0.04) were associated with improvement in fatigue; drowsiness (1.10, 0.04), and feeling of well-being (0.87, 0.02) were associated with improvement in pain.ConclusionThe initial consult by PC achieved significant symptom improvement in patients receiving treatment in the OPC. Further prospective studies are needed.     

A Web-based self-management exercise and diet intervention for breast cancer survivors: Pilot randomized controlled trial

BackgroundRegular exercise and dietary practices have been shown to affect the health-related quality of life (HRQOL) and survival of breast cancer patients.ObjectiveThe current study aimed to investigate whether the WSEDI was a feasible and primarily effective method for promoting exercise and dietary behaviours for breast cancer patients.DesignA 12-week randomized, controlled trial.SettingOncology outpatient treatment clinics at 3 university hospitals and 1 National Cancer Center in South Korea.ParticipantsFifty-nine breast cancer patients who had received curative surgery and completed primary cancer treatment within 12 months prior to the study and who had been diagnosed with stage 0–III cancers within 2 years prior to the study were recruited.MethodsParticipants were randomly assigned to either the intervention group, which used a Web-based self-management exercise and diet intervention program incorporating transtheoretical model (TTM)-based strategies (n = 29), or to the control group, which used a 50-page educational booklet on exercise and diet (n = 28). The intervention efficacy was measured at the baseline and 12 weeks via a Web-based survey that addressed the promotion of exercise and consumption of 5 servings of fruits and vegetables (F&V) per day, dietary quality, HRQOL, anxiety, depression, fatigue, motivational readiness, and self-efficacy.ResultsThe proportion of subjects who performed at least moderate-intensity aerobic exercise for at least 150 min per week; ate 5 servings of F&V per day; and had overall improvements in dietary quality, physical functioning and appetite loss (HRQOL), fatigue, and motivational readiness was greater in the intervention group than in the control group. The self-efficacy with respect to exercise and F&V consumption was greater in the intervention group than in the control group. A Web-based program that targets changes in exercise and dietary behaviours might be effective for breast cancer survivors if the TTM theory has been used to inform the program strategy, although further research with a larger sample size is required to enable definitive conclusions.     

The effectiveness of lifestyle intervention in early pregnancy to prevent gestational diabetes mellitus in Chinese overweight and obese women: A quasi-experimental study

PurposeGestational diabetes mellitus (GDM) is one of the most common complications of pregnancy and is associated with substantially elevated risk of adverse health outcomes for both mothers and offspring. This quasi-experimental trial was conducted to assess whether a lifestyle intervention in early pregnancy can reduce the incidence of GDM and excessive gestational weight (GWG) gain among Chinese overweight women.MethodsConvenience samples of 74 women in gestational weeks 8–12 with a BMI ≥ 24 kg/m² were enrolled. They were divided into intervention (N = 37) or control group (N = 37) according to the time sequence of seeing the doctor. The intervention group was provided with exercise, dietary, weight gain counseling and detailed plans at weeks 8–12 and every month in the second trimester. In addition, each counseling session included a personalized feedback based on their 5-day-records. Follow-up phone calls or emails were conducted every week between antenatal visits. The control group was just provided with exercise, dietary and weight gain counseling at weeks 8–12, besides the usual health education provided at the O&G outpatient department.ResultsThe lifestyle intervention resulted in a lower incidence of gestational diabetes in the intervention group (9/32, 28.1%) compared with the control group (19/34, 55.9%), p = 0.023. Women in the intervention group gained much less weight (6.86 ± 2.31 versus 10.08 ± 3.84 kg, p = 0.000) at the end of second trimester.ConclusionLifestyle intervention in early pregnancy can reduce the incidence of GDM and prevent excessive maternal weight gain in overweight and obese pregnant women.