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

PulseSync

Status: Completed

Conditions: Frailty; Muscle Loss; Sarcopenia

Treatments: Device: Gym Tonic programme and Gym equipment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04661618

GT/RCT/2018/001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 318 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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318 participants in 2 patient groups

GT

Active Comparator group

Description:

12 weeks of progressive training in the first phase and 12 weeks of maintenance training in the second phase.

Treatment:

Device: Gym Tonic programme and Gym equipment

Control

Other group

Description:

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.

Treatment:

Device: Gym Tonic programme and Gym equipment