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

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

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Sarcopenia; Muscle Loss
• Intervention / Treatment: Device: Gym Tonic programme and Gym equipment

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.

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 339511
    • PulseSync

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GT; 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; 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
Other: Control; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PulseSync Pte Ltd
• Collaborators: Singapore Institute of Technology

Publications and helpful links

General Publications

• 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.

Helpful Links

• Promotional website for the Gym Tonic Programme.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2018
• Primary Completion (Actual): July 19, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Frailty; Sarcopenia
• Other Study ID Numbers: GT/RCT/2018/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No