Enhancing the Physical Activity Levels of Community-dwelling Older People With Frailty Through an Exercise Intervention With or Without a Wearable Activity Tracker (WAT)-Based Intervention: a Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This study aims to investigate the feasibility, acceptability, and preliminary effects of a Wearable Activity Tracker (WAT)-based exercise intervention to increase physical activity levels in frail or pre-frail older people. One group of participants will receive a WAT-based exercise intervention incorporated with the support of behavioral change techniques (BCTs) and technical issues, while the other group will receive only an exercise intervention incorporated with BCTs support.
详细描述
Six community centres, which provide similar types of community care and social support services for community-dwelling older people, will be invited by a convenience method to work as collaborators in this study. Using computer-generated random numbers, a biostatistician not affiliated with this study will randomize the centres in a 1:1 ratio into either: the control or the experimental groups (WAT group).
The WAT group will receive a 3-month exercise programme plus WAT intervention which aims to strengthen the participants' motivation to develop the intention to gradually increase their physical activity levels to eventually meet the level recommended for older people by the American Heart Association (AHA). Two face-to-face sessions followed by weekly to monthly telephone sessions offering support on dealing with technical issues and BCTs will be arranged for the experimental group. The additional technical support given alongside the WAT intervention will be gradually withdrawn from the participants. Eventually, all additional measures to support the use of WATs among participants will be stopped. Participants will be left to use the WAT on their own for 3 months during the follow-up period. In addition, they will receive a weekly 45-60 minute center-based structured exercise programme for 3 months, which is designed according to the AHA's recommendations on exercise for older people.
The control group will receive another 3-month exercise programme with face-to-face, and telephone-delivered BCTs follow-up sessions, with the number and timing of all sessions similar to that in the experimental group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
An independent assessor who is blinded to the group allocations will assess the participants' outcomes.
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
- •community-dwelling older people aged > 65 years;
- •able to communicate in Cantonese to ensure that they understand our instructions;
- •able to walk with or without an assistive device and able to complete the Time Up and Go (TUG) test with no specific cutoff point to ensure that their mobility and balance is good enough to join the exercise training;
- •able to use a smartphone;
- •with daily walking steps less than 7000, and
- •in a pre-frail or frail state as determined using the Fried Frailty Index; including: i) having experienced an unintentional loss of 10% of body weight in the past year; ii) exhaustion: by answering 'Yes' to either 'I felt that everything I did was an effort', or 'I could not get going in the last week'; iii) a slow walk time: with an average walking speed in the lowest quintile stratified by median body height; iv) reduced grip strength: with maximal grip strength in the lowest quintile stratified by the body mass index quartile; and v) a Physical Activity Scale for Elderly-Chinese (PASE-C) score in the lowest quartile (i.e., < 30 for men and < 27.7 for women). The presence of 1-2 indicates pre-frailty, > 3 items indicates frailty.
排除标准
- •are older people who:
- •have any physical conditions that hamper their performance of the exercise programme or use of the WAT, such as visual or hearing problems.
- •regularly engage in moderately intense exercise (such as hiking, Tai Chi) for > 3 hours per week.
研究组 & 干预措施
WAT group
The WAT group will receive a 3-month WAT-based exercise training programme, which includes 12 weekly exercise training sessions (an hour each) in addition to 2 face-to-face sessions followed by weekly to monthly telephone sessions offering support on dealing with technical issues and BCTs (7 session in total). The WAT group will be left to use the WAT on their own for 3 months during the follow-up period.
干预措施: WAT (Other)
Control group
The control group will receive a 3-month exercise training programme without a WAT, which also includes 12 weekly exercise training sessions (an hour each) in addition to 7 face-to-face and telephone sessions offering support for BCTs.
结局指标
主要结局
Recruitment rate
时间窗: Enrollment date
The proportion of participants who consent to join the study over the eligible participants.
Adherence to the exercise regimen
时间窗: Throughout the 3-month programme
Exercise adherence will be assessed by the training session attendance, the participants' adherence to the desired levels of MVAP as suggested by the physical trainer and the exercise diary.
Change of sleep quality (wake after sleep onset) measured by ActiGraph wGT3X accelerometer.
时间窗: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention.(* only for the experimental group)
The frequency of wake after sleep onset of the participant will be collected.
Frequency of using the activity tracker
时间窗: Throughout the 3-month programme
The number of days that a participant in the experimental group wears and syncs the device divided by the number of intervention days.
Attrition rate
时间窗: At the end of the 3-month programme
The percentage of participants who withdraw from the study and their reasons for withdrawing.
Occurrence of adverse events at home
时间窗: Throughout the 3-month programme
Any adverse events at home will be recorded.
Change of sleep quality (sleep time) measured by ActiGraph wGT3X accelerometer.
时间窗: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention. (* only for the experimental group)
The participant's total sleep time will be collected.
Change of activity levels (total steps) measured by ActiGraph wGT3X accelerometer.
时间窗: Change from Baseline Activity Level at 1 week, *1 month and * 3 month post-intervention (* only for the experimental group)
The participants' total steps will be collected.
Change of activity levels (activity) measured by ActiGraph wGT3X accelerometer.
时间窗: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention(* only for the experimental group)
The time spent in activities of different intensity (sedentary, light, moderate and vigorous) will be collected.
次要结局
- Activity levels (total steps) assessed by activity monitor (Fitbit)(Throughout the 3-month programme)
- Participants' frailty level will be assessed using Fried Frailty Index (FFI)(Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group))
- Activity levels (time spent in different heart rate zones) assessed by activity monitor (Fitbit)(Throughout the 3-month programme)
- Participants' upper-limb strength will be assessed using a handheld Jamar Hydraulic Hand Dynamometer(Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group))
- Participants' functional mobility will be measured by the timed-up-and-go-test(Baseline, at 1 week, *1 month and *3 month post-intervention)
- Participants' self-reported sedentary behavioral and physical activity will be assessed using Global Physical Activity Questionnaire-Chinese version (C-GPAQ)(Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group))
- Participants' lower-limb strength will be assessed using the 30-second chair stand test(Baseline, at 1 week, *1 month and* 3 month post-intervention (* only for the experimental group))
- Activity levels (total walking distance) assessed by activity monitor (Fitbit)(Throughout the 3-month programme)
- Participants' gait speed will be measured by the 2 minutes walk test(Baseline, at 1 week, 1 month and 3 month post-intervention (* only for the experimental group))
- Participants' exercise self-efficacy will be measured using Chinese Self-Efficacy for Exercise (CSEE) scale(Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group))
- Participants' motivation to engage in physical activity using of the Behavioral Regulation in Exercise Questionnaire-2 (C-BREQ-2)(Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group))
研究者
Dr. Justina Liu Yat Wa
Associate Professor
The Hong Kong Polytechnic University