Clinical trial NCT04661618: A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention.
Official title: A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention on Physical Function and Frailty Reversal, for Elderly Singaporeans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Muscle Loss
Sarcopenia
Lead sponsor: PulseSync Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: Singapore Institute of Technology
First posted: 2020-12-10
Enrollment: 318
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised-Control Trial
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Isometric Muscle Strength (Knee Extension)
timeFrame: week 0, week 12, week 24
measure: Change in Isometric Muscle Strength (Knee Flexion)
timeFrame: week 0, week 12, week 24
measure: Change in Isometric Muscle Strength (Hip Abduction)
timeFrame: week 0, week 12, week 24
measure: Change in Isometric Muscle Strength (Hip Adduction)
timeFrame: week 0, week 12, week 24
measure: Handgrip Strength
timeFrame: week 0, week 12, week 24
measure: SPPB Balance Test - Feet together (side-by-side)
timeFrame: week 0, week 12, week 24
measure: SPPB Balance Test - Semi-Tandem stand
timeFrame: week 0, week 12, week 24
measure: SPPB Balance Test - Tandem stand
timeFrame: week 0, week 12, week 24
measure: SPPB 5 times sit-to-stand
timeFrame: week 0, week 12, week 24
measure: SPPB Speed Walk Test (Normal)
timeFrame: week 0, week 12, week 24
measure: SPPB Speed Walk Test (Fast)
timeFrame: week 0, week 12, week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: PulseSync
Study officials:
References:
citation: Lee SY, Goh A, Tan K, Choo PL, Ong PH, Wong WP, Wee SL. Effectiveness of a community-delivered pneumatic machine resistance training programme (Gym Tonic) for older adults at neighbourhood senior centres - a randomized controlled trial. Eur Rev Aging Phys Act. 2021 Oct 7;18(1):21. doi: 10.1186/s11556-021-00273-x.