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Clinical Trials/NCT03538418
NCT03538418
Completed
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country40 target enrollmentJune 1, 2018
ConditionsFrail Elderly

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frail Elderly
Sponsor
The Hong Kong Polytechnic University
Enrollment
40
Locations
1
Primary Endpoint
Recruitment rate
Status
Completed
Last Updated
6 years ago

Overview

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 The additional technical support given alongside the WAT intervention will be gradually withdrawn from the participants.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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
March 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Justina Liu Yat Wa

Associate Professor

The Hong Kong Polytechnic University

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: Enrollment date

The proportion of participants who consent to join the study over the eligible participants.

Adherence to the exercise regimen

Time Frame: 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.

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Throughout the 3-month programme

Any adverse events at home will be recorded.

Change of sleep quality (sleep time) measured by ActiGraph wGT3X accelerometer.

Time Frame: 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.

Time Frame: 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.

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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