Clinical trial NCT03538418: Enhancing Physical Activity Levels of Frail Older People With a Wearable Activity Tracker-based Exercise Intervention
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Frailty
Wearable technology
Physical activity
Behaviour change
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel (single-blinded) cluster randomized controlled trial involves two groups of participants (the WAT group and the control group). 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 into either: the control or the experimental groups. Therefore, duing the trial, participants in one group receive intervention "in parallel" to participants in the other group (control group).
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria 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.

Primary outcomes:
measure: Frequency of using the activity tracker
timeFrame: Throughout the 3-month programme
measure: Recruitment rate
timeFrame: Enrollment date
measure: Attrition rate
timeFrame: At the end of the 3-month programme
measure: Adherence to the exercise regimen
timeFrame: Throughout the 3-month programme
measure: Occurrence of adverse events at home
timeFrame: Throughout the 3-month programme
measure: Change of activity levels (total steps) measured by ActiGraph wGT3X accelerometer.
timeFrame: Change from Baseline Activity Level at 1 week, *1 month and * 3 month post-intervention (* only for the experimental group)
measure: Change of activity levels (activity) measured by ActiGraph wGT3X accelerometer.
timeFrame: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention(* only for the experimental group)
measure: Change of sleep quality (sleep time) measured by ActiGraph wGT3X accelerometer.
timeFrame: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention. (* only for the experimental group)
measure: Change of sleep quality (wake after sleep onset) measured by ActiGraph wGT3X accelerometer.
timeFrame: Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention.(* only for the experimental group)
Secondary outcomes:
measure: Activity levels (total steps) assessed by activity monitor (Fitbit)
timeFrame: Throughout the 3-month programme
measure: Activity levels (total walking distance) assessed by activity monitor (Fitbit)
timeFrame: Throughout the 3-month programme
measure: Activity levels (time spent in different heart rate zones) assessed by activity monitor (Fitbit)
timeFrame: Throughout the 3-month programme
measure: Participants' lower-limb strength will be assessed using the 30-second chair stand test
timeFrame: Baseline, at 1 week, *1 month and* 3 month post-intervention (* only for the experimental group)
measure: Participants' upper-limb strength will be assessed using a handheld Jamar Hydraulic Hand Dynamometer
timeFrame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
measure: Participants' functional mobility will be measured by the timed-up-and-go-test
timeFrame: Baseline, at 1 week, *1 month and *3 month post-intervention
measure: Participants' gait speed will be measured by the 2 minutes walk test
timeFrame: Baseline, at 1 week, 1 month and 3 month post-intervention (* only for the experimental group)
measure: Participants' exercise self-efficacy will be measured using Chinese Self-Efficacy for Exercise (CSEE) scale
timeFrame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
measure: Participants' frailty level will be assessed using Fried Frailty Index (FFI)
timeFrame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
measure: Participants' self-reported sedentary behavioral and physical activity will be assessed using Global Physical Activity Questionnaire-Chinese version (C-GPAQ)
timeFrame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
measure: Participants' motivation to engage in physical activity using of the Behavioral Regulation in Exercise Questionnaire-2 (C-BREQ-2)
timeFrame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic Universtiy
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Justina LIU, Dr.
role: PRINCIPAL_INVESTIGATOR
References: