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

NCT03538418 | Completed DMC

• 1 other identifier: HSEARS20180320006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Frail Elderly

Keywords

Frailty; Wearable technology; Physical activity; Behaviour change

Outcome Measures

Primary Outcomes (9)

• 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

• Recruitment rate

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

  Enrollment date

• Attrition rate

  The percentage of participants who withdraw from the study and their reasons for withdrawing.

  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.

  Throughout the 3-month programme

• Occurrence of adverse events at home

  Any adverse events at home will be recorded.

  Throughout the 3-month programme

• 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)

• 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)

• 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)

• 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 Outcomes (11)

• Activity levels (total steps) assessed by activity monitor (Fitbit)

  Throughout the 3-month programme

• Activity levels (total walking distance) assessed by activity monitor (Fitbit)

  Throughout the 3-month programme

• Activity levels (time spent in different heart rate zones) assessed by activity monitor (Fitbit)

  Throughout the 3-month programme

• 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)

• 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)

Study Arms (2)

WAT group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

WAT OTHER

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

WAT group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic Universtiy

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Justina LIU, Dr.

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An independent assessor who is blinded to the group allocations will assess the participants' outcomes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 29, 2018
• Study Start: June 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)