- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05908539
A Multi-level and Mixed-method Impact Evaluation for the Jockey Club Elders Get Active Fitness Campaign
The goal of this clinical trial is provide a scientific evaluation on the impact of the Jockey Club Get Fitness Campaign to improve the physical capacity and health condition of the community-dwelling older adults after the COVID-19 pandemic. Participants will take part in any of the four care models:
- a box of exercise equipment
- a box of exercise equipment with verbal briefing
- a box of exercise equipment and engage in the 8-week group-based exercise training
- receive the wonderful box of exercise equipment and engage in the 8-week group-based exercise training together with the 6-week behavioral modification
Participants with greater physical dependency, greater chronic disease burden or lower motivation for social engagement will take part in any of the three care models:
- a box of exercise equipment only
- a box of exercise equipment with verbal briefing
- a box of exercise equipment and engage in the 4-session home-based exercise training, together with the 6-week behavioral modification
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doris Sau Fung Yu, PhD
- Phone Number: 852 3817 6319
- Email: yu1@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Doris Yu, PhD
- Phone Number: 3817 6319
- Email: dyu1@hku.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age above 60 years
- Resident of public rental house
Exclusion Criteria:
- Any contraindication to exercise training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Equipment box (general)
A box of exercise equipment is distributed to community dwelling older adults.
|
Participants receive a box of exercise equipment containing dumbbell, elastic band, hand cycle machine, and booklet of exercise instruction only.
|
Experimental: Equipment box with briefing (general)
A box of exercise equipment is distributed.
Verbal briefing of exercise equipment is provided to community dwelling older adults.
|
Participants receive a box of exercise equipment containing dumbbell, elastic band, hand cycle machine, and booklet of exercise instruction, and they are given verbal briefing on how to use the equipment.
|
Experimental: Group-based exercise (general)
A box of exercise equipment is distributed.
Verbal briefing of exercise equipment and an 8-week group exercise training program is provided to community dwelling older adults.
|
Participants receive al box of exercise equipment.
They attend an 8-week group exercise training program for 1 hour /session and 1 session/ week, and are supervised by a physical fitness training.
The exercise program includes a combination of aerobic, resistance, balance and flexibility exercises.
|
Experimental: Group-based exercise with behavioral modification (general)
A box of exercise equipment is distributed.
Verbal briefing of exercise equipment and an 8-week group exercise training program is provided to community dwelling older adults, following by a 6-week behavioral modification.
|
Participants receive al box of exercise equipment.
They attend an 8-week group exercise training program for 1 hour /session and 1 session/ week, and are supervised by a physical fitness training.
The exercise program includes a combination of aerobic, resistance, balance and flexibility exercises.
After finishing the exercise training program, a 6-week behavioral modification is provided.
Two home visits and four telephone visits are conducted to empower the participants for exercise at home.
|
Experimental: Equipment box (home-bound)
A box of exercise equipment is distributed to home-bound community dwelling older adults.
|
Participants receive a box of exercise equipment containing dumbbell, elastic band, hand cycle machine, and booklet of exercise instruction only.
|
Experimental: Equipment box with briefing (home-bound)
A box of exercise equipment is distributed.
Verbal briefing of exercise equipment is provided to home-bound community dwelling older adults.
|
Participants receive a box of exercise equipment containing dumbbell, elastic band, hand cycle machine, and booklet of exercise instruction, and they are given verbal briefing on how to use the equipment.
|
Experimental: Home-based exercise with behavioral modification (home-bound)
A box of exercise equipment is distributed.
Verbal briefing of exercise equipment and an 8-week group exercise training program is provided to home-bound community dwelling older adults, following by a 6-week behavioral modification.
|
Participants receive al box of exercise equipment.
They attend an 8-week group exercise training program for 1 hour /session and 1 session/ week, and are supervised by a physical fitness training.
The exercise program includes a combination of aerobic, resistance, balance and flexibility exercises.
After finishing the exercise training program, a 6-week behavioral modification is provided.
Two home visits and four telephone visits are conducted to empower the participants for exercise at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Step count
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Step count per day measured by a pedometer
|
Changes from baseline to 8 weeks after start intervention
|
Functional mobility score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Score measured by Life Space Assessment questionnaire (range: 0-120), higher score better performance
|
Changes from baseline to 8 weeks after start intervention
|
Exercise self-efficacy score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Score measured by Self-Efficacy for Exercise Scale questionnaire (range 0-90), higher score higher self-efficacy for exercise
|
Changes from baseline to 8 weeks after start intervention
|
Hand grip strength
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Hand grip strength measured by hand-held dynamometer in unit of KG
|
Changes from baseline to 8 weeks after start intervention
|
Performance of timed up-and-go test
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by timed up-and-go test in unit of second
|
Changes from baseline to 8 weeks after start intervention
|
Mobility limitation score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by Short Physical Performance Battery (range 0-12), higher score better physical performance
|
Changes from baseline to 8 weeks after start intervention
|
Sarcopenia risk score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by Sarcopenia(SARC) questionnaire and calf circumference in unit of cm (range0-20), higher score higher risk of sarcopenia
|
Changes from baseline to 8 weeks after start intervention
|
Frailty risk score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by Edmonton Frail Scale questionnaire (range0-17), higher score more severer frailty
|
Changes from baseline to 8 weeks after start intervention
|
Social connectedness score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by Social Connectedness Scale questionnaire (20-100), higher score stronger social connectedness
|
Changes from baseline to 8 weeks after start intervention
|
Insomnia risk score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by Insomnia Severity Index questionnaire (range0-28), higher score greater severity of insomnia
|
Changes from baseline to 8 weeks after start intervention
|
Mental health score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by Mental Health Inventory questionnaire (range 0-100), higher score better mental health
|
Changes from baseline to 8 weeks after start intervention
|
Fatigue score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by Brief Fatigue Inventory questionnaire (range0-10), higher score greater fatigue
|
Changes from baseline to 8 weeks after start intervention
|
Loneliness score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by UCLA Loneliness Scale questionnaire (range20-80), higher score greater loneliness
|
Changes from baseline to 8 weeks after start intervention
|
Health status self-rated score
Time Frame: Changes from baseline to 8 weeks after start intervention
|
Measured by EQ05D-5L questionnaire (range -0.59-1.0),
higher score better quality of life
|
Changes from baseline to 8 weeks after start intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EGA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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