Enhancing Physical Activity Levels of Frail Older People With a Wearable Activity Tracker-based Exercise Intervention

Frail Elderly Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538418
• Other study ID #: HSEARS20180320006
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: April 2020
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The additional technical support given alongside the WAT intervention will be gradually withdrawn from the participants.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly

Intervention

Other:
• WAT
The WAT intervention consists of 12 weekly WAT-based exercise sessions and 7 sessions of support for BCTs and technical issues.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic Universtiy	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Throughout the 3-month programme
Primary	Recruitment rate	The proportion of participants who consent to join the study over the eligible participants.	Enrollment date
Primary	Attrition rate	The percentage of participants who withdraw from the study and their reasons for withdrawing.	At the end of the 3-month programme
Primary	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.	Throughout the 3-month programme
Primary	Occurrence of adverse events at home	Any adverse events at home will be recorded.	Throughout the 3-month programme
Primary	Change of activity levels (total steps) measured by ActiGraph wGT3X accelerometer.	The participants' total steps will be collected.	Change from Baseline Activity Level at 1 week, *1 month and * 3 month post-intervention (* only for the experimental group)
Primary	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.	Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention(* only for the experimental group)
Primary	Change of sleep quality (sleep time) measured by ActiGraph wGT3X accelerometer.	The participant's total sleep time will be collected.	Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention. (* only for the experimental group)
Primary	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.	Change from Baseline Activity Level at 1 week, *1 month and *3 month post-intervention.(* only for the experimental group)
Secondary	Activity levels (total steps) assessed by activity monitor (Fitbit)	The total steps per week of an individual will be collected.	Throughout the 3-month programme
Secondary	Activity levels (total walking distance) assessed by activity monitor (Fitbit)	The total walking distance per week of an individual will be collected.	Throughout the 3-month programme
Secondary	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.	Throughout the 3-month programme
Secondary	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	Baseline, at 1 week, *1 month and* 3 month post-intervention (* only for the experimental group)
Secondary	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	Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Secondary	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	Baseline, at 1 week, *1 month and *3 month post-intervention
Secondary	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.	Baseline, at 1 week, 1 month and 3 month post-intervention (* only for the experimental group)
Secondary	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	Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Secondary	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).	Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Secondary	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).	Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Secondary	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.	Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)