Efficacy of a neuropsychological training programme for patients with multiple sclerosis – a randomised controlled trial

BACKGROUND: One aim of this project was to investigate the efficacy of a specific training programme for MS patients which also contained compensation strategies and relaxation exercises relevant to everyday life. The other aim was to check the programme's relevance to everyday life. METHOD: 19 patients, randomised into two groups, took part in the study. The participants in the treated group completed a specific neurological training programme which began immediately after the basic testing (visit 1) and lasted 4 weeks, with a total of 12 sessions. The monitoring test was done immediately after the training programme (at visit 2) and the follow-up was 3 months later (visit 3). Both study groups were fully comparable as regards clinical and socio-demographic data and baseline intelligence level. RESULTS: The results of the cognitive training programme were especially evident in the significant improvements in executive functions (CKV) and spatial-constructional abilities (HAWIE-R). Comparison between the treated and the control group showed no significant difference in the fatigue values (MFIS). However, when the treated group was examined over the three times of measurements, the symptoms of fatigue had diminished significantly. Regarding memory, comparison of the groups showed no changes; within the treated group; however, the verbal (VLT) and nonverbal learning and memory (NVLT) improved significantly. The results for sustained attention improved in both groups over time. It must be assumed that a learning effect had occurred here. The depression values (BDI) also improved in both study groups. The follow-up questionnaire showed that 60% (6) attributed an average to above-average benefit to the training. CONCLUSION: To summarise, it is apparent that MS patients with mild to moderate cognitive impairment are able to profit from even a fairly brief neuropsychological training programme and to integrate much of it into their everyday lives. In view of this, it would seem appropriate to offer such a programme as standard, associated with medication.     

Short-term supervised inpatient physiotherapy exercise protocol improves cardiac autonomic function after coronary artery bypass graft surgery – a randomised controlled trial

Objective.?Coronary artery bypass grafting (CABG) is accompanied by severe impairment of cardiac autonomous regulation (CAR). This study aimed to determine whether a short-term physiotherapy exercise protocol post-CABG, during inpatient cardiac rehabilitation (CR), might improve CAR.

Design.?Seventy-four patients eligible for CABG were recruited and randomised into physiotherapy exercise group (EG) or physiotherapy usual care group (UCG). EG patients underwent a short-term supervised inpatient physiotherapy exercise protocol consisting of an early mobilisation with progressive exercises plus usual care (respiratory exercises). UCG only received respiratory exercises. Forty-seven patients (24 EG and 23 UGC) completed the study. Outcome measures of CAR included linear and non-linear measures of heart rate variability (HRV) assessed before discharge.

Results.?By hospital discharge, EG presented significantly higher parasympathetic HRV values [rMSSD, high frequency (HF), SD1)], global power (STD RR, SD2), non-linear HRV indexes [detrended fluctuation analysis (DFA)α1, DFAα2, approximate entropy (ApEn)] and mean RR compared to UCG (p?<?0.05). Conversely, higher values of mean HR, low frequency (LF) (sympathetic activity) and the LF/HF (global sympatho-vagal balance) were found in the UCG.

Conclusions.?A short-term supervised physiotherapy exercise protocol during inpatient CR improves CAR at the time of discharge. Thus, exercise-based inpatient CR might be an effective non-pharmacological tool to improve autonomic cardiac tone in patient's post-CABG.     

Basic life support training: Demonstration versus lecture – A randomised controlled trial

IntroductionBasic life support (BLS) and the use of an automated external defibrillator (AED) improve survival from cardiac arrest. The gold standard for teaching BLS/AED is yet to be identified. The aim of this study was to compare the learning outcome of an instructor-led demonstration with a formal lecture for introducing BLS/AED skills. We hypothesized that a demonstration was superior to a lecture.MethodsFirst year-medical students were randomised to either a demonstration or a lecture using PowerPoint® Presentation for skill introduction during European Resuscitation Council BLS/AED courses. Participants were skill-tested after training and required to perform all skills correctly to pass the test. Finally, all participants were asked to state their preferred teaching method.ResultsOverall, 247 participants were included in the analysis (demonstration group: 124, lecture group: 123). Pass rate was 63% in both groups, p = 1.00.Both groups performed median compression rates within guidelines recommendations, p = 0.09. Mean compression depth was 55 mm (10 mm) in the demonstration group compared with 52 mm (10 mm) in the lecture group, p = 0.05. Median tidal volume was 265 (192, 447) ml and 405 (262, 578) ml, p < 0.001, respectively. The lecture group was 3 s faster at initiating BLS, p < 0.001. In total, 226 (91%) participants preferred demonstration on a manikin for introducing BLS/AED.ConclusionThere was no statistically significant difference in pass rate when comparing a demonstration with a lecture for introducing BLS/AED. The lecture group was slightly faster at initiating BLS. Most participants preferred a demonstration as introduction.     

Statistical analysis plan for the coaching for healthy AGEing trial – a cluster-randomised controlled trial to enhance physical activity and prevent falls in community-dwelling older people

BackgroundThis statistical analysis plan details the Coaching for Healthy AGEing (CHAnGE) trial analysis methodology.ObjectiveTo investigate the effect of a combined physical activity and fall prevention program on physical activity and falls compared to a healthy eating among people aged 60 years and over.MethodsThe CHAnGE trial is a pragmatic parallel-group cluster-randomised controlled trial with allocation concealment and blinded assessors. Clusters are allocated to either (1) a physical activity and fall prevention intervention or (2) to a healthy eating intervention. The primary outcomes are: objectively measured physical activity at 12 months post-randomisation, and self-reported falls throughout the 12-month trial period. Secondary outcomes include the proportion of participants reporting a fall, the proportion of participants meeting the Australian physical activity guidelines, body mass index, eating habits, mobility goal attainment, mobility-related confidence, quality of life, fear of falling, risk-taking behaviour, mood, well-being, self-reported physical activity, disability, and use of health and community services.AnalysisWe will follow the intention-to-treat principle. All analysis will allow for cluster randomisation using a generalised estimating equation approach. The between-group difference in the number of falls per person-year will be analysed using negative binomial regression models. For the continuously scored primary and secondary outcome measures, linear regression models adjusted for corresponding baseline scores will assess the effect of group allocation. Analyses will take into account cluster randomisation and will be adjusted for baseline scores. A subgroup analysis will assess differential effects of the intervention by baseline physical activity levels and history of falls.     

Physiotherapy screening of patients referred for orthopaedic consultation in primary healthcare – A randomised controlled trial

A large proportion of patients who consult primary healthcare for musculoskeletal pain are referred for orthopaedic consultation, but only a small number of these patients are appropriate for orthopaedic intervention. Experienced physiotherapists have the appropriate knowledge to manage musculoskeletal disorders. The primary aim of this randomised study was therefore to evaluate a screening by a physiotherapist of patients referred for orthopaedic consultation compared to standard practice in primary care.Patients referred for orthopaedic consultation (n = 203) were randomised to physiotherapy screening or standard practice. Selection accuracy for orthopaedic intervention and other referrals were analysed with proportion analysis. Patient views of the quality of care were analysed with Mann–Whitney U-test, waiting time with Independent t-test.There was higher selection accuracy for orthopaedic intervention in the physiotherapy screening group (p = 0.002). A smaller proportion of patients in the screening group were referred back to their general practitioner (GP) (p < 0.001) and a larger proportion to the physiotherapy clinic (p < 0.001) compared to standard practice. The proportion of patients referred for further investigations was significantly lower in the physiotherapy screening group (p < 0.039). Waiting time was shorter in the screening group (p < 0.001). A large proportion of the patients reported no hesitation to attend the clinic for future care, no difference between the groups (p < 0.95).The findings in this study suggest that an experienced physiotherapist effectively can screen patients referred for orthopaedic consultation in primary healthcare.     

In a bed or on the floor? – The effect of realistic hospital resuscitation training: A randomised controlled trial

Introduction

In-hospital cardiac arrest has a poor prognosis and often occurs in patients lying in a hospital bed. A bed mattress is a soft compressible surface that may decrease cardiopulmonary resuscitation (CPR) quality. Often hospital CPR training is performed with a manikin on the floor.

Is a chest pain observation unit likely to be cost effective at my hospital? Extrapolation of data from a randomised controlled trial

Objectives: The ESCAPE trial showed that chest pain observation unit (CPOU) care appeared to be cost effective compared with routine care. This finding may not be generalisable to hospitals that currently admit fewer patients than the trial hospital or that require higher direct costs to provide CPOU care. This study aimed to explore these issues in sensitivity analyses and develop a nomogram to allow prediction of whether a CPOU will be cost effective in a specific hospital.     

Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial

Background

Spontaneous breathing trials (SBT) can be exhausting, but the preventive role of rest has never been studied. This study aimed to evaluate whether reconnection to mechanical ventilation (MV) for 1 h after the effort of a successful SBT could reduce the need for reintubation in critically ill patients.

Methods

Randomized multicenter trial conducted in 17 Spanish medical-surgical intensive care units (Oct 2013–Jan 2015). Patients under MV for longer than 12 h who fulfilled criteria for planned extubation were randomly allocated after a successful SBT to direct extubation (control group) or reconnection to the ventilator for a 1-h rest before extubation (rest group). The primary outcome was reintubation within 48 h. Analysis was by intention to treat.

Results

We recruited 243 patients randomized to the control group and 227 to the rest group. Median time from intubation to SBT did not differ between groups [5.5 (2.7, 9.6) days in the control group vs. 5.7 (2.7, 10.6) in the rest group; p = 0.85]. Reintubation within 48 h after extubation was more common in the control than in the rest group [35 (14%) vs. 12 (5%) patients; OR 0.33; 95% CI 0.16–0.65; p < 0.001]. A multivariable regression model demonstrated that the variables independently associated with reintubation were rest [OR 0.34 (95%CI 0.17–0.68)], APACHE II [OR 1.04 (1.002–1.077)], and days of MV before SBT [OR 1.04 (1.001–1.073)], whereas age, reason for admission, and type and duration of SBT were not.

Conclusion

One-hour rest after a successful SBT reduced the rates of reintubation within 48 h after extubation in critically ill patients. Trial registration Clinicaltrials.gov identifier NCT01915563.

     

Can Qigong improve attention in adolescents? A prospective randomised controlled trial

IntroductionThe ability to direct and maintain attention is a prerequisite for learning. Qigong exercises are already commonly practiced in many developed countries to increase attention and memory. The main goal of this study was to examine whether Qigong would improve the attention levels of adolescents (12–14 years of age) when practiced as part of their physical education course.MethodThree groups of 22 individuals were considered: the verum group, which performed true Qigong; the control group, which performed sham, or placebo Qigong; and the waiting list group. In order to evaluate Qigong effects, attention tests (d2) were applied to all groups before the intervention period (t1) and after two and four weeks of practice (t2 and t3, respectively).ResultsAt t1, there was no significant difference between the verum, control and waiting list groups in all measurable features. After 4 weeks of exercise, the verum group was significantly superior in all measurable features in comparison to the control group and the waiting list group. Values in the waiting list group were generally worse than in the control group (placebo Qigong), but there was no significant difference between the control and waiting list group, showing that the placebo offered an effect that was not significantly greater than the effect of no intervention at all.Conclusion‘White Ball’ Qigong was able to improve attention in adolescents after 4 weeks of practice, leading us to conclude that it may be a useful tool when integrated into physical education classes.     

Relaxation as treatment for chronic musculoskeletal pain – a systematic review of randomised controlled studies

Abstract

Objectives: To review studies on relaxation treatment for chronic musculoskeletal pain.

Methods: Searches in the databases PubMed, PEDro, CINAHL, Amed, the electronic library information navigator (ELIN), and the British Medical Journal and Science Direct, found 12 relevant studies. Inclusion criteria were: randomised controlled trials (RCTs); studies including a total of at least 25 subjects at the end of intervention; relaxation techniques as single treatment, or combined with education, with the participants being active in the treatment.

Results: A total of 12 studies fulfilled all inclusion criteria and were reviewed. Quality assessment showed that all studies were of medium quality. The relaxation techniques used were: progressive muscle relaxation ad modum Jacobson (most common), autogenic training ad modum Schultz, hypnosis, guided imagery and biofeedback. Positive effects were found regarding decreases in pain intensity, anxiety, depression, and fatigue (in fibromyalgia). Even decreases in medication and health costs were seen. Increased mobility and use of coping strategies were also reported.

Conclusion: Relaxation training could be effective for patients with chronic musculoskeletal pain. The experimental study designs need to be of improved scientific quality and should, for example, include clear self-training relaxation protocols and suitable control groups. RCTs of high quality are necessary.     

Does vibration training reduce the fall risk profile of frail older people admitted to a rehabilitation facility? A randomised controlled trial

Purpose: To determine the effect of Vibration Training (VT) on functional ability and falls risk among a group of frail older people admitted to an inpatient rehabilitation unit in a regional hospital in New Zealand. Method: A randomized controlled trial of 56 participants (mean 82.01 years in the intervention group and 81.76 years in the control group). VT targeting lower limb muscles with a frequency 30–50 Hz occurred three times per week until discharge. Amplitude progressively increased from 2 to 5?mm to allow the programme to be individually tailored to the participant. The control group received usual care physiotherapy sessions. Outcome measures were: Physiological profile assessment (PPA); and Functional Independence measure (FIM) and Modified Falls Efficacy Scale (MFES). Results: There was a statistically significant difference observed between the two groups in terms of FIM score (F?=?5.09, p?=?0.03) and MFES (F?=?3.52, p?=?0.007) but no difference was observed in terms of PPA scores (F?=?0.96, p?=?0.36). Conclusions: Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of VT in conjunction with usual care physiotherapy in terms of improved functional ability. The study design and the small dosage of VT provided may have precluded any change in falls risk among participants.

• Implications for Rehabilitation

• Vibration training (VT) may assist in reducing the risk of falling among at risk older people.

• Current pressures on health systems (ageing population, reduced hospital length of stay) necessitate the development of innovative strategies to maximise the rehabilitation potential of older people.

• Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of vibration training in conjunction with usual care physiotherapy in terms of improved functional ability.

     

Oral acupuncture in the therapy of craniomandibular dysfunction syndrome – a randomized controlled trial

CONTEXT: Patients with disorders of the stomatognathic system describe pain and clicking phenomena as primary symptoms. Rapid improvement of the pain is required to ensure and maintain adequate patient compliance. OBJECTIVE: The study was intended to assess the effects of acupuncture in patients with temporomandibular disorders as compared to placebo therapy (sham laser); the primary target parameter was the subjective pain sensation. DESIGN: Randomized, placebo-controlled trial. PATIENTS AND METHODS: 23 patients were enrolled and randomly assigned to one of the two groups. One group received acupuncture treatment according to the very-point technique, the other group received sham laser treatment. The following observer-blinded findings were evaluated before and after treatment: subjective pain, mouth opening, and muscular tenderness and pain on pressure. In addition, mandibular joint movement pathways were recorded using electronic axiography. OUTCOMES: Improvements in pain scores (scale, 0-100) in the acupuncture group (19.1 +/- 11.9) were significant (p = 0.03) versus those in the placebo group (6.2 +/- 14.8). Mouth opening showed an insignificant trend towards improvement (p > 0.1) in the acupuncture (5.0 +/- 6.2 mm) versus the placebo group (1.0 +/- 4.7 mm), differences in tenderness and pain on pressure in neck and masticatory muscles were significant (p < 0,05) for most of the muscles having shown pretreatment tenderness or pain. The axiographic tracings were assessed for quality, symmetry and curve characteristics. Recordings of the opening and closing movement in the acupuncture group showed an increased frequency of improvements of curve characteristics as compared to the placebo group. The acupuncture group also showed an increased frequency of improvement in protrusion and retrusion movements, though no statistical significance could be obtained. CONCLUSION: On the basis of the results of the present study, acupuncture may be recommended as acute treatment of craniomandibular disorders, but studies with larger numbers of patients as well as about long-term treatment outcomes should be conducted.     

Early aggressive intervention for infantile atopic dermatitis to prevent development of food allergy: a multicenter,investigator-blinded,randomized, parallel group controlled trial (PACI Study)—protocol for a randomized controlled trial

Background

Atopic dermatitis is the first clinical manifestation of the atopic march, with the highest incidence in the first year of life. Those affected often go on to develop other allergic diseases including food allergy, asthma, and allergic rhinitis. Recent evidence suggests that sensitization to foods may occur through a defective skin barrier which is common in atopic dermatitis in early life. We hypothesize that therapeutic aggressive intervention to treat new onset atopic dermatitis may prevent the development of later allergen sensitization, and associated food allergy, asthma, and allergic rhinitis.

Methods

This study is a multi-center, pragmatic, two-parallel group, assessor-blind, superiority, individually randomized controlled trial. Atopic dermatitis infants (N?=?650) 7–13 weeks old who develop an itchy rash within the previous 28 days are randomly assigned to the aggressive treatment or the conventional treatment in a 1:1 ratio. The primary outcome is oral food challenge-proven IgE-mediated hen’s egg allergy at the age of 28 weeks.

Discussion

This is a novel pragmatic RCT study to examine the efficacy of early aggressive treatment for atopic dermatitis to prevent later food allergy. If our hypothesis is correct, we hope that such a strategy might impact on disease prevention in countries where food allergy is common, and that our results might reduce the frequency and associated costs of all food allergies as well as hens egg food allergy. Long-term follow and other similar studies will help to determine whether such a strategy will reduce the burden of other allergic diseases such as asthma and allergic rhinitis.Trial registration UMIN-CTR: UMIN000028043

     

Is suicide assessment harmful to participants? Findings from a randomized controlled trial

There is considerable debate on whether suicide assessment carries an iatrogenic risk for participants/patients. A double‐blind randomized controlled trial (registration: R000022314) tested the emotional impact of suicide assessment on participants (n = 259) randomly assigned to experimental (n = 122) or control conditions (n = 137). The experimental condition included the Suicidal Affect‐Behavior‐Cognition Scale and intensive death‐related questions, the control condition a quality of life scale. Both included measures of depression, social support and loneliness. Affective states were assessed immediately before and after testing, and research biases minimized. Post‐test debriefing interviews collected qualitative reactions. Experimental participants ranged from nonsuicidal to highly suicidal. Between‐groups ANCOVAs and repeated measures ANOVAs showed no differences by study condition, and no pre‐post‐test affect changes for either condition or suicidal participants (P > 0.10), supporting the null hypothesis of no iatrogenic effects. However, depressive participants in both conditions showed significant decreases in positive affect (P < 0.05). Smallest real difference (SRD) scores approximated clinically meaningful differences and showed 20% of participants had a significant positive survey reaction, 24% a negative reaction, with the rest neutral. Linear regressions revealed depressive symptoms and perceived family support, but not suicidality or other factors, predicted negative affect changes, which was supported by qualitative findings. Social desirability bias was also found in qualitative survey responses. No evidence of iatrogenic effects of suicide assessment were found. Recommendations are made to counter possible negative assessment effects on depressive participants/patients, and nurses and other caregivers are encouraged to talk to patients about suicidal symptoms.     

Time2bHealthy – An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol

BackgroundThe use of parent-focused internet-based programs for the prevention and treatment of childhood obesity has shown promise but there is an acknowledged gap in parent-focused interventions which target the early childhood stage.MethodsThe aim of this study is to determine the efficacy of Time2bHealthy - an online healthy lifestyle program for parents of preschool-aged children. The program will be evaluated using a two-arm, parallel, randomised controlled design. The 11-week program is underpinned by Social Cognitive Theory and consists of interactive modules on healthy eating, physical activity, screen-time and sleep. The intervention also involves elements of social media, where participants share discuss ideas and experiences and they can interact and obtain information with experts. Time2bHealthy is being compared to a comparison condition. Outcomes include change in BMI (primary outcome), dietary intake, physical activity, sleep, child feeding, parental role-modelling and parent self-efficacy. Process evaluation data, such as adherence and engagement with the online forums, will also be collected.DiscussionTime2bHealthy is the first randomised controlled trial to our knowledge to assess the efficacy of an online parent-focussed healthy lifestyle program for preschool-aged children in changing body mass index. Early childhood is a crucial time for establishing healthy lifestyle behaviours and parents play an important role. This study therefore fills an important gap in the literature. If found to be efficacious, Time2bHealthy has potential for broad-reach access and translation into primary health care services.Trial RegistrationThe study is registered with the Australian and New Zealand Clinical Trials Registry (12616000119493).     

So you want to conduct a cluster randomized controlled trial? Lessons from a national cluster trial of early labour

As the discipline of health services research has developed so methods of evaluation have become increasingly sophisticated; where once a ‘simple’ randomized controlled trial would have been considered the gold standard, now terms such as ‘complex interventions’ and the ‘cluster randomized controlled trial’ are hot topics for discussion. The challenges involved in carrying out such studies are rarely presented. In this paper we discuss some of these challenges in relation to ethical and statistical considerations, and illustrate them using a recently completed cluster randomized controlled trial of a decision tool for early labour.