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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661618
• Other study ID #: GT/RCT/2018/001
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: October 15, 2019

Study information

• Verified date: December 2020
• Source: PulseSync Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: October 15, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Muscle Loss
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Singapore	PulseSync	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
PulseSync Pte Ltd	Singapore Institute of Technology

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Promotional website for the Gym Tonic Programme.