Feasibility,Safety, and Beneficial Effects of MCT-Based Ketogenic Diet for Breast Cancer Treatment: A Randomized Controlled Trial Study

Abstract

The present study was aimed to evaluate the safety, tolerability, and beneficial effects of a ketogenic diet (KD) on body composition and blood parameters and survival in patients with breast cancer. In this randomized, controlled trial, 60 patients with locally advanced or metastatic breast cancer and planned chemotherapy, were randomly assigned to a group receiving KDs (n?=?30) or to a control group with standard diet (n?=?30) for 3 months. Serum biochemical parameters and body composition were analyzed at baseline, every 3 weeks and end of each arm. Compliance and safety of KD were also checked weekly. Fasting blood sugar (FBS) was significantly decreased in intervention group compared to the baseline (84.5?±?11.3 vs. 100.4?±?11.8, P?=?0.001). A significant inter-group difference was also observed for FBS level at end of intervention. There was an increasing trend in serum levels of ketone bodies in intervention group (0.007–0.92, P?<?0.001). Compared to the control group, BMI, body weight, and fat% were significantly decreased in intervention group in last visit (P?<?0.001). No severe adverse side effect was found regarding lipid profile and kidney or liver marker. Overall survival was higher in KD group compared to the control group in neoadjuvant patients (P?=?0.04). Our results suggested that chemotherapy combined with KDs can improve the biochemical parameters, body composition, and overall survival with no substantial side effects in patients with breast cancer.     

Comparison of 2-Year Weight Loss Trends in Behavioral Treatments of Obesity: Diet, Exercise, and Combination Interventions

Objective The effects of three cognitive-behavioral weight control interventions for adults were compared: diet only, exercise only, and a combination of diet and exercise. This article reports 2-year follow-up data.Design The three interventions were compared in a randomized, experimental design.Subjects A total of 127 men and women who were at least 14 kg overweight (according to height-weight tables) were recruited from an urban community and assigned randomly to the experimental conditions.Intervention The dietary intervention was a low-energy eating plan adjusted to produce a 1 kg/week loss of weight. The exercise component involved training in walking and a home-based program of up to five exercise periods per week. There were 12 weekly instructional sessions, followed by 3 biweekly and 8 monthly meetings. All sessions were led by registered dietitians.Outcome measures Changes in body weight.Statistical analyses Analysis of variance for weight changes and repeated measures analysis of variance for weight change trends.Results At 1 year, no significant differences were noted among the three groups. The diet-only group lost 6.8 kg, the exercise-only group lost 2.9 kg, and the combination group lost 8.9 kg (P=.09). During the second year, the diet-only group regained weight — reaching 0.9 kg above baseline; the combination group regained to 2.2 kg below baseline; and the exercise-only group regained slightly to 2.7 kg below baseline (P=.36). Repeated measures analysis of variance showed a group-by-time interaction (P=.001); data for the dieting groups best fit a U-shaped regain curve (P=.001).Applications The results suggest that dieting is associated with weight loss followed by regain after treatment ends, whereas exercise alone produced smaller weight losses but better maintenance. The large outcome variability and unequal difficulty of the regimens across groups limit the generalizability of the findings. J Am Diet Assoc. 1996; 96:342-346.     

Effects of an exercise intervention on participation reported by people with disabilities: A mixed methods randomized trial

BackgroundDespite a long history of research on the benefits of exercise for people with mobility impairments, little is known about how exercise affects participation in their daily activities.ObjectiveThis randomized mixed-methods study examined the effects of participating in a structured community-based exercise program on pain, depression, fatigue, exertion and participation in daily activities.MethodStudy participants were recruited from a population-based sample of people who returned a survey (n = 800) and indicated they would be willing to participate in another study. The intervention group was randomly assigned to participate in a physical therapy evaluation and 30 exercise sessions within four months and the control group completed measures only. Ecological momentary assessment and a daily diary was used to evaluate treatment outcomes for the intervention relative to the control group on pain, depression, fatigue, exertion and participation in high exertion activities. We also interviewed a subset of intervention participants to solicit their lived experience from engaging in the exercise intervention.ResultsExercise intervention participants reported 28% less pain and 19% less fatigue than control participants. They also reported engaging in 11% more bathing and grooming, 22% more household chores, and left their homes 13% more than control participants. These results were mirrored in qualitative interview results.ConclusionsParticipating in an exercise program leads to less pain and fatigue and more participation in activities that require relatively high levels of exertion like bathing and leaving home.     

A Worksite Program for Overweight Middle-Aged Men Achieves Lesser Weight Loss With Exercise Than With Dietary Change

Objective To compare changes in total and regional body composition using dual energy X-ray absorptiometry (DEXA) after subjects lost weight through change in diet or exercise.Design A 12-month, randomized, controlled study of two weight-loss interventions — low-fat diet ad libitum or moderate, unsupervised exercise — in free-living, middle-aged men. Compliance was determined at monthly measurement sessions through food records and activity logs; DEXA scans were performed every 3 months.Subjects/setting Fifty-eight overweight men (mean body mass INDEX=29.0±2.6; mean AGE=43.4±5.7 years) recruited from a national corporation were assigned randomly to diet, exercise, or control groups.Interventions One group reduced dietary fat to 26.4% of energy intake but kept activity unchanged; another group self-selected aerobic exercise (three sessions per week at 65% to 75% maximum heart rate) but kept diet unchanged. A control group maintained weight.Main outcome measures At 12 months, measurements of weight, total and regional fat mass and lean mass, energy intake, and percentage dietary fat; physical activity indexes. Statistical analyses Results were analyzed using paired t tests and analysis of variance.Results Mean weight loss was 6.4±3.3 kg in dieters and 2.6+3.0 kg in exercisers; control subjects maintained weight. DEXA scans revealed that 40% of dieters’ weight loss was lean tissue; more than 80% of weight lost by exercisers was fat. Exercisers maintained limb lean tissue and lost fat mass.Conclusions Greater total weight and lean tissue loss occurred when subjects lost weight through a low-fat diet consumed ad libitum than when subjects participated in unsupervised aerobic exercise. Use of DEXA enabled identification of progressive total and regional changes in fat and lean tissue. J Am Diet Assoc. 1997; 97:37–42.     

Effects of 12-week aerobic exercise on cue-induced drug craving in methamphetamine-dependent patients and the moderation effect of working memory

ObjectiveTo explore the effect of 12-week aerobic exercise of varying intensity on cue-induced drug craving in methamphetamine (MA)-dependent patients and how this effect may be moderated or mediated by changes in cognitive function.MethodFifty-seven MA-dependent patients were randomly divided into three groups. Two exercise groups were engaged in a 12-week exercise program that involved three 30-min sessions per week of moderate- or high-intensity aerobic exercise on a cycle ergometer. The control group maintained daily life in a drug rehabilitation center for 12 weeks. Inhibitory control, working memory, and cue-induced drug craving were assessed before and after the intervention via Stroop task, 2-back task and visual analogue scale, respectively.ResultsA 12-week program of high-, but not medium-, intensity aerobic exercise significantly reduced cue-induced drug craving and improved working memory performance, while did not improve inhibitory control. Multiple linear regressions revealed that the effects of aerobic exercise on cue-induced drug craving were moderated by working memory.ConclusionsHigh-intensity aerobic exercise could be used to reduce cue-induced drug cravings of MA-dependent patients while also providing benefits in working memory. For patients with improved working memory, 12-week aerobic exercise can significantly reduce cue-induced drug craving, and the higher the exercise intensity, the greater the decrease in craving. These results suggest that appropriate high-intensity exercise would be a positive tool to promote drug rehabilitation for patients without any physical or medical conditions, and the improvement of working memory is important for exercise-induced effects.     

Positive Effects of “Textured Lunches” Gatherings and Oral Exercises Combined with Physical Exercises on Oral and Physical Function in Older Individuals: A Cluster Randomized Controlled Trial

Objectives

Proper nutrition and physical exercises are essential to prevent frailty in older adults. Proper masticatory performance and oral function may influence on physical activities as well since the mouth is the entrance of nutrition and digestion. Thus, the present study aimed to test the combined program of specially devised lunch gatherings containing textured foods with oral and physical exercises on the improvement of oral and physical function in community-dwelling older adults.

Design

A Cluster randomized controlled trial

Setting and Participants

Eighty-six community-dwelling older adults in Daito city, Japan, were randomly assigned into control (n = 43) or intervention (n = 43) groups.

Intervention

The control group performed the physical exercise regimen only. The intervention group participated in a 12-week physical and oral exercise program and ate a so-called “munchy lunch” that introduced textured foods with proper nutrients together after performing the physical exercise twice a week following brief dietary instruction at the intervention onset. Physical training and lunch gatherings were held at local public centers.

Measurements

The differences in measured variables for physical and oral function between baseline and 12 weeks of intervention were statistically tested. Results: Oral function as measured by tongue pressure increased significantly in the intervention group (p=0.031), but not in the control group. Physical properties and activities, including body fat percentage and results of the timed up and go test, decreased more significantly in the intervention group than in controls (p<0.05).

Conclusions

Our findings suggest that a combined program of textured lunch gatherings with oral and physical exercises may improve physical and oral function as a preventative approach for frailty in community-dwelling older adults.

     

The Effects of a Multimodal Intervention Trial to Promote Lifestyle Factors Associated With the Prevention of Cardiovascular Disease in Menopausal and Postmenopausal Australian Women

The purpose of this study was to test the efficacy of a multimodal intervention (Women's Wellness Program) to improve women's cardiovascular risk factors. This 12-week randomized experiment with a control group targeted women 50–65 years living in the general population. Women in the intervention group were provided with a consultation with a registered nurse at which time biophysical cardiovascular risk measures were taken and health education was provided in both verbal and written form. Women were encouraged to review their smoking, nutrition, and water intakes and to commence an exercise program that included aerobic fitness exercises. Women in the control group continued their normal activities. The sample consisted of 90 women aged 50–65 years. Pre- and postintervention assessment utilized seven measures of cardiovascular risk factors: waist-to-hip ratio (WHR), body mass index (BMI), blood pressure, heart rate, weight, exercise levels, and smoking.

Analysis of covariance indicated that the intervention was effective in improving women's aerobic exercise activity and decreasing smoking. The data from all five biophysical outcome measures supported the efficacy of the intervention, with significant decreases seen in the women's WHR, BMI, blood pressure, and measured weight. Study implications suggest that this type of intervention may provide an effective, clinically manageable therapy for women who prefer a self-directed approach to preventing and decreasing cardiovascular risk factors.     

Randomised controlled trial (RCT) of daily aerobic exercise for inpatient cannabis withdrawal: A study protocol

Background and aimsCannabis withdrawal is thought to be a major contributor to relapse to cannabis use and is now included in the DSM-5. Aerobic exercise relieves withdrawal symptoms from tobacco and other drugs, but has yet to be tested in cannabis users.MethodsA prospective, single blind, parallel-group RCT comparing daily aerobic exercise to a control stretching intervention.SettingA seven-day inpatient hospital admission, with follow-up at 28 days’ post-discharge.ParticipantsThe study population will be 80 cannabis dependent adults seeking assistance with cannabis withdrawal.Intervention and comparatorParticipants in the Intervention group will undergo 35 min of aerobic exercise daily, at 60% of their VO₂ Max, on an exercise bicycle. The Control group will participate in a structured non-aerobic daily stretching routine for 35 min daily. Both groups receive treatment as usual in the withdrawal management unit of the hospital.MeasurementsThe primary outcome measure is the severity of cannabis withdrawal symptoms assessed daily using the Cannabis Withdrawal Scale and the Marijuana Cravings Questionnaire – pre and post exercise, across the week. Mechanisms by which exercise may affect cannabis withdrawal will be assessed by analysis of endogenous cannabinoids, and plasma and urine cannabinoid levels.DiscussionThis is the first RCT of aerobic exercise for cannabis dependence that has a valid control group to aid in interpretation of findings. Should the intervention prove effective, it would give empirical support to an inexpensive and accessible treatment approach for drug withdrawal management.     

Diet and gene interaction.

Objective: To investigate the effect of chromium picolinate (CP) supplementation on body composition, resting metabolic rate (RMR), selected biochemical parameters and iron and zinc status in moderately obese women participating in a 12-week exercise program.

Methods: Forty-four women, 27 to 51 years of age, were randomly assigned to two groups based on their body mass index. Subjects received either 400 μg/day of chromium as a CP supplement or a placebo in double-blind fashion and participated in a supervised weight-training and walking program two days per week for 12 weeks. Body composition and RMR were measured at baseline, 6 and 12 weeks. Selected biochemical parameters and iron and zinc status were measured at baseline and 12 weeks.

Results: Body composition and RMR were not significantly changed by CP supplementation. No significant differences in fasting plasma glucose, serum insulin, plasma glucagon, serum C-peptide and serum lipid concentrations or in iron and zinc indices were found between the two groups over time. Serum total cholesterol concentration significantly decreased (p = 0.0016) over time for all subjects combined, probably as a result of the exercise training. Exercise training significantly reduced total iron binding capacity (TIBC) by 3% for all subjects combined (p = 0.0011).

Conclusions: Twelve weeks of 400 μg/day of chromium as a CP supplement did not significantly affect body composition, RMR, plasma glucose, serum insulin, plasma glucagon, serum C-peptide and serum lipid concentrations or iron and zinc indices in moderately obese women placed on an exercise program. The changes in serum total cholesterol levels and TIBC were a result of the exercise program.     

Should Lactating Women Exercise?

The safety of recreational exercise for lactating mothers has been examined in a prospective, intervention study. Thirty-three women, who were 6–8 weeks postpartum and breast-feeding exclusively were randomly chosen to join either an exercise or a control group. The exercise group took part in a program of aerobic activities averaging 4.5 sessions per week. After 12 weeks, aerobic capacity was significantly higher in the women who had exercised than in the controls, but no differences in body weight, body fatness, energy expenditure, or resting metabolic rate (RMR) were noted. The exercise program had no effect on breast milk output or composition or infant weight gain. This demonstrates that recreational exercise sufficient to improve cardiovascular fitness without substantially altering energy balance does not adversely affect lactation performance.     

A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors

Exercise and a healthy diet are beneficial after cancer, but are not uniformly adopted by cancer survivors. This study reports on the feasibility, acceptability, and effectiveness of a self-management-based nutrition and exercise intervention for Australian cancer survivors. Adult survivors (n = 25) during curative chemotherapy (stratum 1[S1]; n = 11) or post-treatment (stratum 2 [S2]; n = 14) were recruited prospectively from a single center. The Flinders Living Well Self-Management Program? (FLW Program) was utilized to establish patient-led nutrition and exercise goals and develop a tailored 12-wk intervention plan. Fortnightly reviews occurred with assessments at baseline, 6 and 12 wk. A recruitment and retention rate of 38% and 84% were observed. Both strata maintained total skeletal muscle mass. Small reductions in body mass index, hip circumference, and percentage body fat, and small increases in hand grip strength and exercise capacity among subjects in both strata were observed. No significant differences were observed between strata; however, significant increases in exercise capacity and global health status for S2 were observed from baseline to 12 wk. FLW Program is a feasible mode of delivering nutrition and exercise intervention to cancer survivors and it appears that there are no barriers to implementing this program early during chemotherapy. Hence, the additive effect of gains achieved over a longer duration is promising and this should be explored in randomized controlled trials adequately powered to observe clinically and statistically significant improvements in relevant outcomes.     

八段锦对社区老年人平衡功能影响效果的整群随机对照试验研究

目的 评价八段锦锻炼6个月对社区老年人平衡功能的影响。方法 使用两平行组整群随机对照试验的方法对我国5个省（市）40个社区的1 028名60~80岁社区居住老年人进行干预研究。干预组研究对象（20个社区、523名）进行每天1 h、每周5 d、持续6个月的八段锦锻炼和3次预防老年人跌倒健康教育；对照组研究对象（20个社区、505名）仅接受3次预防跌倒健康教育。研究主要指标为Berg平衡量表（BBS）得分，次要指标包括单脚站立时间、双脚前后站立时间、闭目原地踏步时间、计时起立行走时间。结果 1 028名研究对象进入分析，包括731名女性（71.11%）和297名男性（28.89%），年龄（69.87±5.67）岁。与基线调查相比，干预3个月后干预组BBS得分较对照组增加3.05（95%CI：2.23~3.88）分（P<0.001）；干预6个月后干预组BBS得分较对照组增加4.70（95%CI：4.03~5.37）分（P<0.001）。与对照组相比，干预6个月后干预组研究对象的各项次要指标均有改善（P<0.05）。结论 八段锦运动可以提高60~80岁社区老年人的平衡功能，运动时间越长，改善效果越好。     

我国职业场所高血压综合干预效果评价

目的 评价在职业场所开展高血压综合干预的效果。方法 采用整群随机对照设计,在全国选取20个分中心,每个分中心选取条件相匹配的2~4家职业场所,随机分为管理组和常规组。管理组采取职业场所心血管病一级预防和高血压患者规范化管理的综合干预策略,每位患者至少管理2年;常规组沿用现行管理办法,收集基线及2年时的资料。本研究对职业场所中入选的30家国企单位（管理组20家,常规组10家）高血压患者资料进行分析。主要指标为高血压控制率,干预效果为管理组差值（率/均值）-常规组差值（率/均值）。结果 共有2 622名患者完成2年随访,其中,管理组2 055人,常规组567人。实施综合干预后,与常规组相比,管理组患者SBP和DBP的干预效果分别为-7.5 mmHg和-3.9 mmHg（P<0.05）,BMI为-0.4 kg/m²（P<0.05）,规律运动率和饮酒率分别为36.4%和-14.0%（P<0.05）,而吸烟率为-6.1%（P>0.05）,血压控制率的干预效果为25.0%（P<0.05）。亚组分析显示高中文化程度（27.6%）、白领（41.9%）、属于医疗机构已分离企业（41.9%）的患者控制率干预效果更好（P<0.05）。结论 在职业场所开展高血压综合干预可显著改善高血压控制状况。     

Randomized trial of the short-term effects of dieting compared with dieting plus aerobic exercise on lactation performance

BACKGROUND: Limiting postpartum weight retention is important for preventing adult obesity, but the effect of weight loss on lactation has not been studied adequately. OBJECTIVE: We evaluated whether weight loss by dieting, with or without aerobic exercise, adversely affects lactation performance. DESIGN: At 12+/-4 wk postpartum, exclusively breast-feeding women were randomly assigned for 11 d to a diet group (35% energy deficit; n = 22), a diet plus exercise group (35% net energy deficit; n = 22), or a control group (n = 23). Milk volume, composition, and energy output; maternal weight, body composition, and plasma prolactin concentration; and infant weight were measured before and after the intervention. RESULTS: Weight loss averaged 1.9, 1.6, and 0.2 kg in the diet, diet + exercise, and control groups, respectively (P < 0.0001) and was composed of 67% fat in the diet group and nearly 100% fat in the diet + exercise group. Change in milk volume, composition, and energy output and infant weight did not differ significantly among groups. However, there was a significant interaction between group and baseline percentage body fat: in the diet group only, milk energy output increased in fatter women and decreased in leaner women. The plasma prolactin concentration was higher in the diet and diet + exercise groups than in the control group. CONCLUSIONS: Short-term weight loss (approximately 1 kg/wk) through a combination of dieting and aerobic exercise appears safe for breast-feeding mothers and is preferable to weight loss achieved primarily by dieting because the latter reduces maternal lean body mass. Longer-term studies are needed to confirm these findings.     

Does Resistance Training Improve the Functional Capacity and Well Being of Very Young Anorexic Patients? A Randomized Controlled Trial

PurposeWe determined the effects of a 3-month low–moderate-intensity strength training program (2 sessions/week) on functional capacity, muscular strength, body composition, and quality of life (QOL) in 22 young (12–16 yrs) anorexic outpatients.MethodsPatients were randomly assigned to a training or control group (n = 11 [10 females] each). Training sessions were of low intensity (loads for large muscle groups ranging between 20%–30% and 50%–60% of six repetitions maximum [6RM] at the end of the program). We measured functional capacity by the time up and go and the timed up and down stairs tests. Muscular strength was assessed by 6RM measures for seated bench and leg presses. We estimated percent body fat and muscle mass. We assessed patients' QOL with the Short Form-36 items.ResultsThe intervention was well tolerated and did not have any deleterious effect on patients' health, and did not induce significant losses in their body mass. The only studied variable for which a significant interaction (group × time) effect was found (p = .009) was the 6RM seated lateral row test.ConclusionsLow–moderate-intensity strength training does not seem to add major benefits to conventional psychotherapy and refeeding treatments in young anorexic patients.     

Computerized exercise program does not affect stress levels of asymptomatic VDT users

The purpose of this study was to determine whether a computerized exercise program could reduce stress levels in office workers who use video display terminals (VDTs). Fifty workers were randomly assigned to either an exercise or a control group. Twenty-four subjects were instructed to exercise twice a day for 15 minutes per session for a period of 8 weeks; the remaining 26 subjects in the control group were given no exercise program. Four dimensions of stress were measured before and after the exercise period using the Personal Strain Questionnaire (PSQ), a self-reported measure of physical and psychological stress. A multivariate T-test (Hotelling’s T ² ) was used to compare changes in stress levels between the two groups of workers, but no significant differences were found. Further analysis of the exercise group revealed that difference in compliance rates among workers did not significantly influence changes in stress levels. These results indicate that this type of exercise program does not reduce stress in asymptomatic VDT users.     

Dietary fiber and associations with adiposity and fasting insulin among college students with plausible dietary reports

ObjectiveWe examined dietary fiber intake, food sources of dietary fiber, and relation of dietary fiber to body composition and metabolic parameters in college students with plausible dietary reports.MethodsStudents (18–24 y of age) provided data on anthropometry, fasting blood chemistries, and body composition (bioelectric impedance). Diet and physical activity were assessed with the Diet History Questionnaire and the International Physical Activity Questionnaire. Plausible dietary reporters were identified (±1 SD cutoffs for reported energy intake as a percentage of predicted energy requirement). Multiple regression analyses were conducted with the total (n = 298) and plausible (n = 123) samples, adjusting for age, race, sex, smoking status, physical activity, energy intake, and fat-free mass (where applicable).ResultsFood sources of dietary fiber were similar in men and women. In the plausible sample compared with the total sample, dietary fiber was more strongly associated with fat mass (β = ?0.24, P < 0.001), percentage of body fat (β = ?0.23, P < 0.001), body mass index (β = ?0.11, P < 0.01), waist circumference (β = ?0.67, P < 0.05), and fasting insulin (β = ?0.15, P < 0.001). When the effect of sex was investigated, dietary fiber was inversely related to fasting insulin and fat mass in men and women and inversely related to percentage of body fat, body mass index, and waist circumference in men only (P < 0.05).ConclusionInclusion of implausible dietary reports may result in spurious or weakened diet–health associations. Dietary fiber is negatively associated with fasting insulin levels in men and women and consistently associated with adiposity measurements in men.     

Intermittent exercise in response to cigarette cravings in the context of an Internet-based smoking cessation program

BackgroundInterventions using sustained aerobic exercise programs to aid smoking cessation have resulted in modest, short-term cessation rates comparable to conventional cessation methods. No smoking cessation trial to date has prescribed intermittent bouts of exercise in response to nicotine cravings.ObjectivesThis pilot randomized controlled trial examined the feasibility and efficacy of an Internet-based smoking cessation program alone (CON) vs. the same Internet-based program + intermittent exercise in response to cigarette cravings (EX).Study populationParticipants (N = 38; mean age = 43.6 [SD = 11.5]; 60.5% women) were generally healthy, inactive adult smokers who desired to quit.ResultsThe overall retention rate was 60.5% (n = 23), and no significant retention rate differences were found between groups (EX vs. CON). Although retained participants achieved a higher cessation rate (26.1%) than all enrolled participants (15.8%), adjusted intent-to-treat and per-protocol binary logistic regression analyses revealed no significant cessation rate differences between EX and CON groups. Linear regression results indicated that additional days of self-reported exercise on the study website during the intervention phase predicted significantly higher reduction rates among EX group participants, F(2, 16) = 31.08, p < .001.ConclusionsResults were mixed with regard to the incremental benefit of exercise in the presence of the apparently valuable Internet-based smoking cessation program. The results support findings from related research and underscore the need for additional investigation into both the mechanisms underlying the effect of exercise on cigarette cravings and the challenges of poor adherence in the context of exercise-based smoking cessation interventions.     

Community-based exercise program is cost-effective by preventing care and disability in Japanese frail older adults

BackgroundIn Japan, older adults are assessed by frailty checklist for care prevention. However, the effect of care prevention programs in community-dwelling frail older adults is still unclear.ObjectivesThe purpose of this study was to investigate whether the care prevention program would reduce care and disability and to measure its cost-effectiveness in frail older adults.DesignThis is a prospective study using propensity score matching.Setting and subjectsA total of 610 community-dwelling older adults were recruited in 2 cities of Japan.InterventionSubjects in the exercise group (n = 305) attended physical exercise sessions once a week for 16 consecutive weeks. The exercise sessions were in a standardized format consisting of moderate-intensity aerobic exercise, progressive strength training, flexibility and balance exercises, and cool-down activities. The control group (n = 305) received only screening evaluation.MeasurementsPrimary outcome was long term care insurance requirement certification during the 1-year follow-up period. Secondary outcome measurements were changes of frailty checklist, and care and medical cost.ResultsTwenty-five subjects (8.1%) in the exercise group and 55 (18%) in the control group were newly certified for long-term care insurance service requirement in 1 year after the intervention (RR = 2.16, 95% CI = 1.46–3.20). Consequently, the health care cost for the subjects in the exercise group was significantly lower than in the control group (P < .001). Moreover, subjects in the exercise group had significant improvements in total scores of the frailty checklist compared with the control group that worsened after 1 year (exercise group: from 7.41 ± 3.98 to 7.11 ± 4.00, control group: from 7.34 ± 4.27 to 8.02 ± 4.81, F = 12.84, P < .001).ConclusionThese results suggested that physical exercise is effective in preventing the progression of frailty and further disability in older adults living in the community. We could save heath care costs by our care prevention program.