Individualized Exercise Program Plus Behavioral Change Enhancement Strategies for Managing Fatigue in Frail Older People
NCT ID: NCT03394495
Last Updated: 2024-02-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
184 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-02-26
Study Completion Date
2021-01-01
Brief Summary
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This project aims to investigate the effects of an individualized exercise programme with and without BCE strategies for community-dwelling frail older people with general fatigue, so as to reduce their fatigue and improve their physical endurance, exercise self-efficacy, and habitual physical activity, while reducing their symptoms of frailty.
Twelve district community health centres will be randomized to one of the three study groups: the combined (COMB) group, receiving the 16-week combined intervention consisting of individualized exercise training and Behavioural Change Enhancement programmes plus two booster sessions at 2 and 6 months after the programme; the exercise (EXER) group, receiving exercise training and health talks only; or the control group, receiving health talks only. Participants from each centre will be placed in their centre's corresponding group.
It is hypothesized that the COMB group will achieve a significantly greater reduction in fatigue and a greater improvement in their physical endurance, exercise self-efficacy, and habitual physical activity, and a significantly greater reduction in their frailty symptoms, when compared with the EXER and control groups at 1 week and 6 and 12 months after completing the interventions.
Twelve district community health centres will be randomized to one of the three study groups: the combined (COMB) group, receiving the 16-week combined intervention consisting of individualized exercise training and Behavioural Change Enhancement programmes plus two booster sessions at 2 and 6 months after the programme; the exercise (EXER) group, receiving exercise training and health talks only; or the control group, receiving health talks only. Participants from each centre will be placed in their centre's corresponding group.
It is hypothesized that the COMB group will achieve a significantly greater reduction in fatigue and a greater improvement in their physical endurance, exercise self-efficacy, and habitual physical activity, and a significantly greater reduction in their frailty symptoms, when compared with the EXER and control groups at 1 week and 6 and 12 months after completing the interventions.
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Detailed Description
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All twelve community centres, which provide similar types of community care and social support services for community-dwelling older people, have been invited by a convenience method to work as collaborators in this study. The target population of this study are community-dwelling frail older people with general fatigue with a nonspecific cause who will be recruited through the community centres. Using computer-generated random numbers, a biostatistician not affiliated with this study will randomize the centres into either: control, EXER, or COMB. The number of participants recruited in each centre will be in proportion to the size of the centre.
Participants allocated to the COMB group will receive a 16-week programme with a combination of the BCE programme and exercise training. The BCE programme is designed based on the Health Action Process Approach (HAPA) model and was piloted by the principal investigator, which aims to motivate the participants to develop the intention to actively manage their fatigue; and to encourage them to gradually exceed the perceived limits of their energy and to recondition their bodies by participating in exercise according to their individual exercise regimens. The BCE programme consists of three phases (the goal initiation, plan formulation and action execution) with 6 face-to-face 1-hour sessions plus two booster BCE sessions at 2 and 6 months after the programme.
For the exercise training, a weekly 45-60 minute centre-based exercise programme, which is designed according to the American Heart Association's recommendations on exercise for older people will be arranged from weeks 4-16 during the execution phase. The exercise sessions consist of balance training, resistance exercises, and aerobic training. All participants will receive circuit training with set exercises, but the dosage of different components will be tailor-made for each participant by a physiotherapist after having their physical conditions examined.
The EXER group will receive a 16-week programme with a combination of exercise training and centre-based health talks on the management of different health issues with the exception of fatigue.
The control group will attend centre-based health talks only.
The number and timing of the health talks for the other two groups will be similar to those in the BCE sessions.
Participants allocated to the COMB group will receive a 16-week programme with a combination of the BCE programme and exercise training. The BCE programme is designed based on the Health Action Process Approach (HAPA) model and was piloted by the principal investigator, which aims to motivate the participants to develop the intention to actively manage their fatigue; and to encourage them to gradually exceed the perceived limits of their energy and to recondition their bodies by participating in exercise according to their individual exercise regimens. The BCE programme consists of three phases (the goal initiation, plan formulation and action execution) with 6 face-to-face 1-hour sessions plus two booster BCE sessions at 2 and 6 months after the programme.
For the exercise training, a weekly 45-60 minute centre-based exercise programme, which is designed according to the American Heart Association's recommendations on exercise for older people will be arranged from weeks 4-16 during the execution phase. The exercise sessions consist of balance training, resistance exercises, and aerobic training. All participants will receive circuit training with set exercises, but the dosage of different components will be tailor-made for each participant by a physiotherapist after having their physical conditions examined.
The EXER group will receive a 16-week programme with a combination of exercise training and centre-based health talks on the management of different health issues with the exception of fatigue.
The control group will attend centre-based health talks only.
The number and timing of the health talks for the other two groups will be similar to those in the BCE sessions.
Conditions
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Fatigue
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
A three-arm parallel (single-blinded) cluster randomized controlled trial involves three groups of participants (the COMB, the EXER and the control group). Twelve community health centres that provide similar types of community care and social support services for community-dwelling older people, have been 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: control, EXER, or COMB group. So during the trial, participants in one group receive combination intervention "in parallel" to participants in the other two groups (the control group and the exercise group).
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
An independent assessor who is blinded to the group allocations will assess the participants' outcomes.
Study Groups
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BCE Combination group
16-week BCE programme with exercise training.
Six 1-hour sessions of BCE programme and a weekly 45-60 minute centre-based exercise programme from week 4 to week 16.
Group Type
EXPERIMENTAL
BCE Combination group
Intervention Type
OTHER
The combination intervention programme consists of a weekly exercise training sessions and 6 sessions of Behavioral Change Enhancement (BCE) programme.
Exercise group
16-week programme with health talks and exercise training.
Six 1-hour sessions of health talks and a weekly 45-60 minutes centre-based exercise programme from week 4 to week 16.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Control group
Six sessions of centre-based health talks on the management of different health issues with the exception of fatigue.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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BCE Combination group
The combination intervention programme consists of a weekly exercise training sessions and 6 sessions of Behavioral Change Enhancement (BCE) programme.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* community-dwelling older people aged \> 70 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; and
* in a frail state with exhaustion as determined using the Fried Frailty Index (FFI), including: 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 grip 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). The presence of \> 3 items indicates frailty, and one criterion indicates that they suffer from exhaustion.
* 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; and
* in a frail state with exhaustion as determined using the Fried Frailty Index (FFI), including: 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 grip 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). The presence of \> 3 items indicates frailty, and one criterion indicates that they suffer from exhaustion.
Exclusion Criteria
* are suffering from any disease in which fatigue is a dominant symptom (such as neurodegenerative diseases, cancer, and end-stage renal failure cachexia cases;
* have been hospitalized for \> 5 days in the preceding 3 months, which may lead to muscle wasting due to recent bed rest or reduced activity levels during hospitalization;
* underwent major surgery (such as total joint replacement, major abdominal surgeries) during the last 6 months;
* are confined to bed or restricted by the permanent use of a wheelchair;
* report that they regularly perform moderately intense exercise (such as hiking, Tai Chi) for \> 3 hours per week;
* are terminally ill;
* have been diagnosed with major depression entailing frequent adjustments of their antidepressants to control unstable depressive moods. The criteria were chosen to avoid recruiting people with depression-induced fatigue. However, a consistent feeling of fatigue may manifest as a depressed mood. Thus, the participants' mood will be assessed using the Chinese-Geriatric Depression Scale (C-GDS).
* have been hospitalized for \> 5 days in the preceding 3 months, which may lead to muscle wasting due to recent bed rest or reduced activity levels during hospitalization;
* underwent major surgery (such as total joint replacement, major abdominal surgeries) during the last 6 months;
* are confined to bed or restricted by the permanent use of a wheelchair;
* report that they regularly perform moderately intense exercise (such as hiking, Tai Chi) for \> 3 hours per week;
* are terminally ill;
* have been diagnosed with major depression entailing frequent adjustments of their antidepressants to control unstable depressive moods. The criteria were chosen to avoid recruiting people with depression-induced fatigue. However, a consistent feeling of fatigue may manifest as a depressed mood. Thus, the participants' mood will be assessed using the Chinese-Geriatric Depression Scale (C-GDS).
Minimum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Justina Liu Yat Wa
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Yat-wa Justina Liu
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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Justina Liu
Hong Kong, , Hong Kong
Site Status
Countries
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Hong Kong
References
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Reference Type
BACKGROUND
Liu JYW, Yin YH, Kor PPK, Kwan RYC, Lee PH, Chien WT, Siu PM, Hill KD. Effects of an individualised exercise programme plus Behavioural Change Enhancement (BCE) strategies for managing fatigue in frail older adults: a cluster randomised controlled trial. BMC Geriatr. 2023 Jun 16;23(1):370. doi: 10.1186/s12877-023-04080-0.
Reference Type
DERIVED
Liu JYW, Kor PPK, Lee PL, Chien WT, Siu PM, Hill KD. Effects of an Individualized Exercise Program Plus Behavioral Change Enhancement Strategies for Managing Fatigue in Older People Who Are Frail: Protocol for a Cluster Randomized Controlled Trial. Phys Ther. 2019 Dec 16;99(12):1616-1627. doi: 10.1093/ptj/pzz130.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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15600717
Identifier Type: -
Identifier Source: org_study_id
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