Frail ElderlyNCT03538418
Enhancing Physical Activity Levels of Frail Older People With a Wearable Activity Tracker-based Exercise Intervention
A study testing WAT in people with Frail Elderly, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frail Elderly
- What is being tested?
- WAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Frail Elderly
- Being tested
- WAT
- Keywords
- Frailty, Wearable technology, Physical activity, Behaviour change
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATOther
The WAT intervention consists of 12 weekly WAT-based exercise sessions and 7 sessions of support for BCTs and technical issues.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the 3-month programme
Recruitment rate
The proportion of participants who consent to join the study over the eligible participants.
Measured: Enrollment date
Attrition rate
The percentage of participants who withdraw from the study and their reasons for withdrawing.
Measured: 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.
Measured: Throughout the 3-month programme
Occurrence of adverse events at home
Any adverse events at home will be recorded.
Measured: Throughout the 3-month programme
Change of activity levels (total steps) measured by ActiGraph wGT3X accelerometer.
The participants' total steps will be collected.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
The total steps per week of an individual will be collected.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Jun 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University
- Investigators
- Justina LIU, Dr., Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538418
- Sponsor's protocol ID
- HSEARS20180320006
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2018
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03538418
- Acronym / sponsor ID
- HSEARS20180320006
- Conditions
- Frail Elderly
- Keywords
- Frailty, Wearable technology, Physical activity, Behaviour change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| WAT group | Experimental | Other: WATThe 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WATThe WAT intervention consists of 12 weekly WAT-based exercise sessions and 7 sessions of support for BCTs and technical issues. | Other | WAT group |
Primary outcome
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.
Recruitment rate
Time frame: Enrollment date
The proportion of participants who consent to join the study over the eligible participants.
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.
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.
Occurrence of adverse events at home
Time frame: Throughout the 3-month programme
Any adverse events at home will be recorded.
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.
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 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.
11 secondary outcomes
Activity levels (total steps) assessed by activity monitor (Fitbit)
Time frame: Throughout the 3-month programme
Activity levels (total walking distance) assessed by activity monitor (Fitbit)
Time frame: Throughout the 3-month programme
Activity levels (time spent in different heart rate zones) assessed by activity monitor (Fitbit)
Time frame: Throughout the 3-month programme
Participants' lower-limb strength will be assessed using the 30-second chair stand test
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
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
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
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
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)
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)
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)
Time frame: Baseline, at 1 week, *1 month and *3 month post-intervention (* only for the experimental group)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justina LIU, Dr. principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WAT in people with Frail Elderly, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of using the activity tracker (time frame: Throughout the 3-month programme). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.