An interventional study of WAT in Frail Elderly, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Other
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.
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 The additional technical support given alongside the WAT intervention will be gradually withdrawn from the participants.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.
The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria are older people who:
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.
Other: WAT
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.
The WAT intervention consists of 12 weekly WAT-based exercise sessions and 7 sessions of support for BCTs and technical issues.
Frequency of using the activity tracker
The number of days that a participant in the experimental group wears and syncs the device divided by the number of intervention days.
Time frame: Throughout the 3-month programme
Recruitment rate
The proportion of participants who consent to join the study over the eligible participants.
Time frame: Enrollment date
Attrition rate
The percentage of participants who withdraw from the study and their reasons for withdrawing.
Time frame: At the end of the 3-month programme
Adherence to the exercise regimen
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.
Time frame: Throughout the 3-month programme
Occurrence of adverse events at home
Any adverse events at home will be recorded.
Time frame: Throughout the 3-month programme
Change of activity levels (total steps) measured by ActiGraph wGT3X accelerometer.
The participants' total steps will be collected.
Time frame: Change from Baseline Activity Level at 1 week, *1 month and * 3 month post-intervention (* only for the experimental group)
Change of activity levels (activity) measured by ActiGraph wGT3X accelerometer.
The time spent in activities of different intensity (sedentary, light, moderate and vigorous) will be collected.
Time frame: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention(* only for the experimental group)
Change of sleep quality (sleep time) measured by ActiGraph wGT3X accelerometer.
The participant's total sleep time will be collected.
Time frame: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention. (* only for the experimental group)
Change of sleep quality (wake after sleep onset) measured by ActiGraph wGT3X accelerometer.
The frequency of wake after sleep onset of the participant will be collected.
Time frame: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention.(* only for the experimental group)
Activity levels (total steps) assessed by activity monitor (Fitbit)
The total steps per week of an individual will be collected.
Time frame: Throughout the 3-month programme
Activity levels (total walking distance) assessed by activity monitor (Fitbit)
The total walking distance per week of an individual will be collected.
Time frame: Throughout the 3-month programme
Activity levels (time spent in different heart rate zones) assessed by activity monitor (Fitbit)
The time spent in different heart rate zones of an individual will be collected.
Time frame: Throughout the 3-month programme
Participants' lower-limb strength will be assessed using the 30-second chair stand test
Participants will be asked to stand up and sit down as many as they can within 30 seconds on a standard chair. The total number of standing up from a chair will be counted. More number indicates better lower-limb strength
Time frame: Baseline, at 1 week, *1 month and* 3 month post-intervention (* only for the experimental group)
Participants' upper-limb strength will be assessed using a handheld Jamar Hydraulic Hand Dynamometer
It will be measured by handheld Jamar Hydraulic Hand Dynamometer with kilogram (kg). Greater force in kg indicates better upper-limb strength
Time frame: 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
Record the time in second that participants complete the timed up and go test to indicate their functional mobility
Time frame: Baseline, at 1 week, *1 month and *3 month post-intervention
Participants' gait speed will be measured by the 2 minutes walk test
Record the time in second that participants complete the 2 minutes walk test to indicate the their gait speed.
Time frame: 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
The CSEE scale contains of 9 items. Each item is rated on 11-point Liker scale from 0 = no confidence to 10 = full of confidence. All item scores are summed to get the total score which ranges from 0 to 90 with a higher score indicates higher exercise self-efficacy
Time frame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Participants' frailty level will be assessed using Fried Frailty Index (FFI)
Fried Frailty Index includes: i) 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 handgrip strength: with maximal grip strength in the lowest quintile stratified by body mass index quartile; and v) the Physical Activity Scale for the Elderly-Chinese (PASE-C) score in the lowest quintile (i.e., \< 30 for men and \< 27.7 for women).
Time frame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Participants' self-reported sedentary behavioral and physical activity will be assessed using Global Physical Activity Questionnaire-Chinese version (C-GPAQ)
The C-PAQ comprises 16 questions designed to estimate an individual's self-perceived level of physical activity in three domains (occupational, transport-related and discretionary or leisure time).
Time frame: 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)
C-BREQ-2 is a 19-item questionnaire assessing five dimensions: amotivation, external regulation, introjected regulation, identified regulation, and intrinsic regulation. Each item is rated on a 5-point scale ranging from 0 = "not true for me" to 4 = "very true for me", with higher scores indicative of higher motivation.
Time frame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
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The Hong Kong Polytechnic University