- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06090253
A Hybrid Effectiveness-implementation Evaluation on Programs Promoting Healthy Aging With Sport Exercise (PHASE Program)
January 5, 2026 updated by: The University of Hong Kong
The goal of this clinical trial is to provide scientific evaluation on the effects of Promoting Healthy Aging with Sport Exercise (PHASE) Programs on the functional capacity of older.
Based on the participants' mental well-being and physical health status, they will be provided with several tailored exercise intervention, including 1) football training; 2) gero-technology enhanced multi-component exercise; 3) slow sports and exercise; 4) walking exercise; 5) home-based exercise.
A control group is also recruited and provided with no exercise intervention.
Study Overview
Status
Recruiting
Conditions
Detailed Description
This clinical trial is aimed to match a range of sport exercise to older adults who are in the different phase of transition along the continuum of intrinsic capacity, and to explore effective measures to promote healthy aging.
The effectiveness of the tailored interventions will be tested among the six study arms of older adults with different intrinsic capacities, with five intervention arms and one control.
Exercise intensity will be measured for each participant.
The outcomes are overall health status, physical function, psychological function, and cognitive function.
The outcomes are measured at baseline (pre-intervention), 3 months (post-intervention), and 6 months (post-intervention) to explore the program benefits.
Study Type
Interventional
Enrollment (Estimated)
1940
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Doris Sau Fung YU, PhD
- Phone Number: 852 3817 6319
- Email: dyu1@hku.hk
Study Locations
-
-
-
Hong Kong, Hong Kong
- Recruiting
- The University of Hong Kong
-
Contact:
- Doris Sau Fung Yu, PhD
- Phone Number: 3817 6319
- Email: dyu1@hku.hk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age above 60 years
Exclusion Criteria:
- Any contraindication to exercise training
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Active
Gerotechnology enhanced multi-component exercise or Football training sessions.
|
Intervention courses will be divided into 3 categories: Musculoskeletal training course, Neuromuscular and fall prevention training course, and cardiometabolic training course.
The courses will be enabled by wearable technology, digital platform and visual display.
Each of the courses will be 8 weeks in length (1 session per week), and 60 minutes per session.
The Football Training Programme will be arranged (10 training sessions+1 game day per stage, 4 stages per season).
held on artificial turf football pitch or indoor sport facilities in 5 regions
|
|
Experimental: General community-dwelling aged cohort
Gerotechnology enhanced multi-component exercise.
|
Intervention courses will be divided into 3 categories: Musculoskeletal training course, Neuromuscular and fall prevention training course, and cardiometabolic training course.
The courses will be enabled by wearable technology, digital platform and visual display.
Each of the courses will be 8 weeks in length (1 session per week), and 60 minutes per session.
|
|
Experimental: Geriatric symptoms
Walking exercise and slow sports and exercise.
|
Two interventions will be provided: A) Walk-focused intervention, B) Disease-related walk intervention for participants with chronic diseases.
Participants will receive 10 training sessions (once or twice per week, 2 hours per session) conducted by professional fitness instructors.
The training programs can be selected according to the participants' preference, including water exercises, stretching/fitness/gymnastics, slow walking/jogging, sports massage, Tai Chi, Yoga, etc.
|
|
Experimental: Chronic disease burden
Walking exercise and slow sports and exercise.
|
Two interventions will be provided: A) Walk-focused intervention, B) Disease-related walk intervention for participants with chronic diseases.
Participants will receive 10 training sessions (once or twice per week, 2 hours per session) conducted by professional fitness instructors.
The training programs can be selected according to the participants' preference, including water exercises, stretching/fitness/gymnastics, slow walking/jogging, sports massage, Tai Chi, Yoga, etc.
|
|
Experimental: Frail
Elderly home gym training service.
|
The proposed elderly home gym training services will be conducted by professional fitness instructors and tailor-made for the participants.
4 personal training sessions will be assigned (once per week, 45 to 60 minutes per session).
|
|
No Intervention: Control
No training session will be provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health status self-rated score
Time Frame: Changes from baseline to 3 month and 6 month post-intervention
|
Measure by EQ05D-5L (range -0.59-1.0),
higher score better quality of life
|
Changes from baseline to 3 month and 6 month post-intervention
|
|
Mobility limitation score
Time Frame: Changes from baseline to 3 month and 6 month post-intervention.
|
Measured by Short Physical Performance Battery (range 0-12), higher score better physical performance
|
Changes from baseline to 3 month and 6 month post-intervention.
|
|
Activity level
Time Frame: Changes from baseline to 3 month and 6 month post-intervention
|
Measured by International Physical Activity Questionnaire.
|
Changes from baseline to 3 month and 6 month post-intervention
|
|
Functional mobility score
Time Frame: Changes from baseline to 3 month and 6 month post-intervention
|
Score measured by Life Space Assessment questionnaire (range: 0-120), higher score better performance
|
Changes from baseline to 3 month and 6 month post-intervention
|
|
Sarcopenia risk score
Time Frame: Changes from baseline to 3 month and 6 month post-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 3 month and 6 month post-intervention
|
|
Hand grip strength
Time Frame: Changes from baseline to 3 month and 6 month post-intervention
|
Hand grip strength measured by hand-held dynamometer in unit of KG
|
Changes from baseline to 3 month and 6 month post-intervention
|
|
Loneliness score
Time Frame: Changes from baseline to 3 month and 6 month post-intervention
|
Measured by UCLA Loneliness Scale questionnaire (range20-80), higher score greater loneliness
|
Changes from baseline to 3 month and 6 month post-intervention
|
|
Cognitive function score
Time Frame: Changes from baseline to 3 month and 6 month post-intervention
|
Measured by Montreal Cognitive Assessment (range 0-30), A score of 26 or over is considered to be normal.
|
Changes from baseline to 3 month and 6 month post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
October 13, 2023
First Submitted That Met QC Criteria
October 13, 2023
First Posted (Actual)
October 19, 2023
Study Record Updates
Last Update Posted (Actual)
January 8, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- pHase
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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