A Hybrid Effectiveness-implementation Evaluation on Programs Promoting Healthy Aging With Sport Exercise (PHASE Program)

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT06090253
Collaborator
(none)
1,940
1
6
36
53.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gerotechnology enhanced multi-component exercise
  • Behavioral: Home-based exercise
  • Behavioral: Walking exercise
  • Behavioral: Slow sports and exercise
  • Behavioral: Football
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1940 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
A Hybrid Effectiveness-implementation Evaluation on Programs Promoting Healthy Aging With Sport Exercise (PHASE Program)
Actual Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2026
Anticipated Study Completion Date :
Aug 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active

Gerotechnology enhanced multi-component exercise or Football training sessions.

Behavioral: 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.

Behavioral: Football
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.

Behavioral: 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.

Behavioral: Walking exercise
Two interventions will be provided: A) Walk-focused intervention, B) Disease-related walk intervention for participants with chronic diseases.

Behavioral: Slow sports and exercise
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.

Behavioral: Walking exercise
Two interventions will be provided: A) Walk-focused intervention, B) Disease-related walk intervention for participants with chronic diseases.

Behavioral: Slow sports and exercise
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.

Behavioral: Home-based exercise
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.

Outcome Measures

Primary Outcome Measures

  1. Health status self-rated score [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

  2. Mobility limitation score [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

  3. Activity level [Changes from baseline to 3 month and 6 month post-intervention]

    Measured by International Physical Activity Questionnaire.

  4. Functional mobility score [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

  5. Sarcopenia risk score [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

  6. Hand grip strength [Changes from baseline to 3 month and 6 month post-intervention]

    Hand grip strength measured by hand-held dynamometer in unit of KG

  7. Loneliness score [Changes from baseline to 3 month and 6 month post-intervention]

    Measured by UCLA Loneliness Scale questionnaire (range20-80), higher score greater loneliness

  8. Cognitive function score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age above 60 years
Exclusion Criteria:
  • Any contraindication to exercise training

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: Doris Sau Fung YU, PhD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT06090253
Other Study ID Numbers:
  • PHASE
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Hong Kong

Study Results

No Results Posted as of Oct 19, 2023