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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Ageing Well

Intervention / Treatment
-----------------
* Behavioral: Gerotechnology enhanced multi-component exercise
* Behavioral: Home-based exercise
* Behavioral: Walking exercise
* Behavioral: Slow sports and exercise
* Behavioral: Football


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 60 years Exclusion Criteria: Any contraindication to exercise training

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Gerotechnology enhanced multi-component exercise or Football training sessions. | Behavioral: Gerotechnology enhanced multi-component exercise<br>* 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.<br>Behavioral: Football<br>* 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<br>|
| Experimental: General community-dwelling aged cohort<br>Gerotechnology enhanced multi-component exercise. | Behavioral: Gerotechnology enhanced multi-component exercise<br>* 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.<br>|
| Experimental: Geriatric symptoms<br>Walking exercise and slow sports and exercise. | Behavioral: Walking exercise<br>* Two interventions will be provided: A) Walk-focused intervention, B) Disease-related walk intervention for participants with chronic diseases.<br>Behavioral: Slow sports and exercise<br>* 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.<br>|
| Experimental: Chronic disease burden<br>Walking exercise and slow sports and exercise. | Behavioral: Walking exercise<br>* Two interventions will be provided: A) Walk-focused intervention, B) Disease-related walk intervention for participants with chronic diseases.<br>Behavioral: Slow sports and exercise<br>* 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.<br>|
| Experimental: Frail<br>Elderly home gym training service. | Behavioral: Home-based exercise<br>* 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).<br>|
| No Intervention: Control<br>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 | 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 | 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 | Measured by International Physical Activity Questionnaire. | Changes from baseline to 3 month and 6 month post-intervention | 
| Functional mobility score | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Community-dwelling, Functional Capacity, Ageing