Exercise Coaching Program With Aerobic Exercise and Resistance Exercise for Prefrail and Frail Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months.
研究概览
简要总结
This is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program, (2) a 6-month resistance exercise program, versus (3) a 6-month psychoeducation program on healthy lifestyle for improving frailty, physical performance, and quality of life in frail/prefrail older persons. After 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence.
详细描述
This is a single-blind, cluster randomized, cross-over trial to investigate the effectiveness of (1) a 6-month aerobic exercise program led by trained young-old exercise coaches, (2) a 6-month resistance exercise program led by trained young-old exercise coaches, versus (3) a 6-month psychoeducation program on healthy lifestyle led by retired nurses for improving frailty, physical performance, and quality of life in frail/prefrail older persons. A total of 390 frail/prefrail older persons are randomized into one of the three programs in groups of 6 to 10 persons.
After 6 months, participants receive the other two programs in a pseudo random order to explore any effects of program sequence. The sequences are: (a) resistance exercise, aerobic exercise, psychoeducation; (b) aerobic exercise, resistance exercise, psychoeducation; and (c) psychoeducation, resistance exercise, aerobic exercise. The entire intervention period lasts for 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •screened as frail or prefrail using cutoff scores of the 5-item FRAIL scale;
- •living in the community and planned to reside in the area for the duration of the study;
- •gave informed consent to participate in the study
排除标准
- •heart failure, uncontrolled angina, severe pulmonary disease, or end-stage disease with a life expectancy of less than 18 months
- •diagnosed dementia or a cutoff score falling below threshold suggestive of dementia using the clock-face test
- •has another member of the household participating in the study
- •difficulty in communication with study personnel due to speech or hearing problems
- •other medical, psychiatric, or behavioural factors that may interfere with study participation or the ability to follow the intervention protocol
- •Temporary Exclusion Criteria:
- •had stroke, hip fracture, myocardial infarction, major heart surgery, deep vein thrombosis, pulmonary embolus, spinal surgery, or hip or knee replacement within the previous 6 months;
- •currently prescribed activity limitation or weight-bearing limitation by a formal healthcare professional;
- •limited physical activity due to chest pain or dyspnoea without definitive treatment by a healthcare provider;
- •currently consume more than 14 alcoholic drinks per week;
- •currently enrolling in another randomized trial involving lifestyle or pharmacological interventions
研究组 & 干预措施
Aerobic-Resistance-Education (ARE)
Participants first receive 6 months of aerobic exercise, then 6 months of resistance exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Aerobic exercise (A) Behavioral: Resistance exercise (R) Behavioral: Healthy lifestyle education (E)
干预措施: Healthy lifestyle education (E) (Behavioral)
Education-Resistance-Aerobic (ERA)
Participants first receive 6 months of education program on healthy lifestyle, then 6 months of resistance exercise, and finally 6 months of aerobic exercise.
Behavioral: Healthy lifestyle education (E) Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A)
干预措施: Resistance exercise (R) (Behavioral)
Education-Resistance-Aerobic (ERA)
Participants first receive 6 months of education program on healthy lifestyle, then 6 months of resistance exercise, and finally 6 months of aerobic exercise.
Behavioral: Healthy lifestyle education (E) Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A)
干预措施: Healthy lifestyle education (E) (Behavioral)
Education-Resistance-Aerobic (ERA)
Participants first receive 6 months of education program on healthy lifestyle, then 6 months of resistance exercise, and finally 6 months of aerobic exercise.
Behavioral: Healthy lifestyle education (E) Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A)
干预措施: Aerobic exercise (A) (Behavioral)
Resistance-Aerobic-Education (RAE)
Participants first receive 6 months of resistance exercise, then 6 months of aerobic exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A) Behavioral: Healthy lifestyle education (E)
干预措施: Resistance exercise (R) (Behavioral)
Resistance-Aerobic-Education (RAE)
Participants first receive 6 months of resistance exercise, then 6 months of aerobic exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A) Behavioral: Healthy lifestyle education (E)
干预措施: Aerobic exercise (A) (Behavioral)
Resistance-Aerobic-Education (RAE)
Participants first receive 6 months of resistance exercise, then 6 months of aerobic exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Resistance exercise (R) Behavioral: Aerobic exercise (A) Behavioral: Healthy lifestyle education (E)
干预措施: Healthy lifestyle education (E) (Behavioral)
Aerobic-Resistance-Education (ARE)
Participants first receive 6 months of aerobic exercise, then 6 months of resistance exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Aerobic exercise (A) Behavioral: Resistance exercise (R) Behavioral: Healthy lifestyle education (E)
干预措施: Resistance exercise (R) (Behavioral)
Aerobic-Resistance-Education (ARE)
Participants first receive 6 months of aerobic exercise, then 6 months of resistance exercise, and finally 6 months of education program on healthy lifestyle.
Behavioral: Aerobic exercise (A) Behavioral: Resistance exercise (R) Behavioral: Healthy lifestyle education (E)
干预措施: Aerobic exercise (A) (Behavioral)
结局指标
主要结局
Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months.
时间窗: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in upper body strength measured by 30-second bicep curl test at baseline, 6 months, 12 months and 18 months. Performance is defined by the frequency of arm curls completed in 30 seconds while sitting in a chair. Higher frequencies represent better upper body strength, lower frequencies represent poor upper body strength.
Change in physical frailty status measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months.
时间窗: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in physical frailty status is measured by the 5-item FRAIL scale at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 5, with 0 representing robust health status, 1-2 pre-frail, and 3-5 frail.
Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months.
时间窗: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in physical performance measured by Short Physical Performance Battery (SPPB) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 0 to 12. Higher scores represent better physical performance, lower scores represent poor physical performance.
Change in quality of life measured by World Health Organization Quality of Life - Older Adult Module (WHOQoL-OLD) at baseline, 6 months, 12 months and 18 months.
时间窗: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in quality of life measured by World Health Organization Quality of Life - Older Adult Module (WHOQoL-OLD) at baseline, 6 months, 12 months and 18 months. It has a range of scores from 24 to 120. Higher scores indicate better quality of life, lower scores indicate poor quality of life.
Change in aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months.
时间窗: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in aerobic exercise capacity measured by 2-minute step test at baseline, 6 months, 12 months and 18 months. Performance on the test is defined as the number of right-side steps of the criterion height completed in 2 minutes. Higher frequencies represent better aerobic exercise capacity, lower frequencies represent poor aerobic exercise capacity.
Change in comprehensive frailty status measured by the 32-item Frailty Index (32-FI) at baseline, 6 months, 12 months and 18 months.
时间窗: 4 time points including: baseline, 6 months, 12 months, 18 months
Change in comprehensive frailty status measured by the 32-item Frailty Index (32-FI) at baseline, 6 months, 12 months and 18 months. The index is calculated by the sum score divided by the total number of valid responses, ranging from 0 to 1. Frailty status is defined as: robust (FI ≤ 0.08), prefrail (0.08 \< FI \< 0.25), and frail (FI ≥ 0.25).
次要结局
- Change in handgrip strength measured by the (Jamar® Hand Dynamometer - Plus+ Digital - 200 lb. Capacity) at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in nutrition status measured by Mini Nutritional Assessment-Short Form at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in digit span measured by the Digit Span Test at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in physical activity measured by Physical Activity Scale for the Elderly (PASE) at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in pain severity measured by Face Pain Scale - Revised at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in cognitive performance measured by Digit Symbol Substitution Test at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in verbal fluency was measured by the Verbal Fluency Test at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in logical memory was measured by the Logical Memory Test at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in health literacy measured by Chinese Health Literacy for Chronic Care at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in activities of daily living measured by Modified Barthel Index at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in instrumental activities of daily living measured by Lawton Instrumental Activities of Daily Living at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in social network measured by Lubben Social Network Scale at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in sleep quality measured by Pittsburgh Sleep Quality Index at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in depressive symptoms measured by Patient Health Questionnaire - 9 (PHQ-9) at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
- Change in extent of mobility measured by the Life Space Questionnaire at baseline, 6 months, 12 months and 18 months.(4 time points including: baseline, 6 months, 12 months, 18 months)
研究者
Professor Terry Y.S. Lum
Professor
The University of Hong Kong