A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention.

Study Overview
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Brief Summary
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Launched in April 2015 , Gym Tonic is the first of its kind cross-border exercise-as-medicine partnership between research institutions, business enterprises and service providers from Singapore and Finland. What sets Gym Tonic apart from other exercise programmes is its singular focus on strength training, necessary for frailty prevention and maintenance of functional independence for the elderly. This randomized-control trial is to validate the Gym Tonic programme and data as well measuring its effectiveness in improving physical functions and reversing frailty.

Detailed Description
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The RCT is conducted in 3 eldercare community centers. In each center, a group of elderly will be randomly sorted into 2 groups. An intervention group and a control group. The intervention group will go through 12 weeks of Gym Tonic progressive training programme. While the control group acts as a control. After the first 12 weeks, the intervention group will be going through another 12 weeks of Gym Tonic maintenance programme, while the control group will be going through the Gym Tonic progressive training programme. Measurements of physical functions, isometric strength and frailty will be conducted pre trial, post 12 weeks and post 24 weeks.

Official Title
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A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention on Physical Function and Frailty Reversal, for Elderly Singaporeans.

Conditions
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Frailty, Muscle Loss, Sarcopenia

Intervention / Treatment
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* Device: Gym Tonic programme and Gym equipment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 65 years and above Pre-frail or mildly frail, as measured by the 5 CHS criteria of physical frailty: unintentional weight loss, slowness, weakness, exhaustion, low activity level or FRAIL Able to ambulate without personal assistance Enrolled into the 3 sites above Exclusion Criteria: Bedbound Terminally ill patients with life expectancy <12 months Significant cognitive impairment Major depression Wear pacemaker Severe audiovisual impairment Any progressive, degenerative neurologic disease Participating in other interventional studies Unavailable to participate for the full duration of the study

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised-Control Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GT<br>12 weeks of progressive training in the first phase and 12 weeks of maintenance training in the second phase. | Device: Gym Tonic programme and Gym equipment<br>* 12 week progressive training - Strength exercises on 6 pneumatic gym equipment following Gym Tonic's protocol twice a week 12 weeks maintenance training - Strength exercises on 6 pneumatic gym equipment following Gym Tonic's protocol once a week<br>|
| Other: Control<br>No intervention for the first phase and will be active comparator in the second phase. No intervention for the first 12 weeks (first phase) and 12 weeks of progressive training in the second phase. | Device: Gym Tonic programme and Gym equipment<br>* 12 week progressive training - Strength exercises on 6 pneumatic gym equipment following Gym Tonic's protocol twice a week 12 weeks maintenance training - Strength exercises on 6 pneumatic gym equipment following Gym Tonic's protocol once a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Isometric Muscle Strength (Knee Extension) | Measured via isometric performance recorder fixed to exercise machine for the right and left leg. | week 0, week 12, week 24 | 
| Change in Isometric Muscle Strength (Knee Flexion) | Measured via isometric performance recorder fixed to exercise machine for the right and left leg. | week 0, week 12, week 24 | 
| Change in Isometric Muscle Strength (Hip Abduction) | Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement. | week 0, week 12, week 24 | 
| Change in Isometric Muscle Strength (Hip Adduction) | Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement. | week 0, week 12, week 24 | 
| Handgrip Strength | Subject will be seated, with the arm unsupported, elbow joint at 90 degrees and wrist in a neutral position while holding the hand dynamometer. Subject would be required to squeeze the grip with maximum strength upon command for three attempts. The best result would be recorded. | week 0, week 12, week 24 | 
| SPPB Balance Test - Feet together (side-by-side) | To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held. | week 0, week 12, week 24 | 
| SPPB Balance Test - Semi-Tandem stand | To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held. | week 0, week 12, week 24 | 
| SPPB Balance Test - Tandem stand | To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held. | week 0, week 12, week 24 | 
| SPPB 5 times sit-to-stand | Seated with arms folded across chest and with their back against the chair, Stand up fully and sit down fully with the back against the chair as quickly as possible. Scored point will be determined by the time to completely finish 5 repetitions. | week 0, week 12, week 24 | 
| SPPB Speed Walk Test (Normal) | To walk 4 metres at participant's usual speed, scored point will be determined based on time taken to complete the 4-Metre walk. | week 0, week 12, week 24 | 
| SPPB Speed Walk Test (Fast) | To walk 4 metres at participant's fastest speed, scored point will be determined based on time taken to complete the 4-Metre walk. | week 0, week 12, week 24 |