search
Back to results

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

Primary Purpose

Frailty, Muscle Loss, Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Gym Tonic programme and Gym equipment
Sponsored by
PulseSync Pte Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

  • PulseSync

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

GT

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in Isometric Muscle Strength (Knee Extension)
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Change in Isometric Muscle Strength (Knee Flexion)
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Change in Isometric Muscle Strength (Hip Abduction)
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
Change in Isometric Muscle Strength (Hip Adduction)
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
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.
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.
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.
SPPB Balance Test - Tandem stand
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2020
Last Updated
December 3, 2020
Sponsor
PulseSync Pte Ltd
Collaborators
Singapore Institute of Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT04661618
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
July 19, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PulseSync Pte Ltd
Collaborators
Singapore Institute of Technology

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Muscle Loss, Sarcopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised-Control Trial
Masking
Investigator
Masking Description
Data is anonymized
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GT
Arm Type
Active Comparator
Arm Description
12 weeks of progressive training in the first phase and 12 weeks of maintenance training in the second phase.
Arm Title
Control
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Gym Tonic programme and Gym equipment
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Isometric Muscle Strength (Knee Extension)
Description
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Time Frame
week 0, week 12, week 24
Title
Change in Isometric Muscle Strength (Knee Flexion)
Description
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Time Frame
week 0, week 12, week 24
Title
Change in Isometric Muscle Strength (Hip Abduction)
Description
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
Time Frame
week 0, week 12, week 24
Title
Change in Isometric Muscle Strength (Hip Adduction)
Description
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
Time Frame
week 0, week 12, week 24
Title
Handgrip Strength
Description
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.
Time Frame
week 0, week 12, week 24
Title
SPPB Balance Test - Feet together (side-by-side)
Description
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
Time Frame
week 0, week 12, week 24
Title
SPPB Balance Test - Semi-Tandem stand
Description
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
Time Frame
week 0, week 12, week 24
Title
SPPB Balance Test - Tandem stand
Description
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
Time Frame
week 0, week 12, week 24
Title
SPPB 5 times sit-to-stand
Description
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.
Time Frame
week 0, week 12, week 24
Title
SPPB Speed Walk Test (Normal)
Description
To walk 4 metres at participant's usual speed, scored point will be determined based on time taken to complete the 4-Metre walk.
Time Frame
week 0, week 12, week 24
Title
SPPB Speed Walk Test (Fast)
Description
To walk 4 metres at participant's fastest speed, scored point will be determined based on time taken to complete the 4-Metre walk.
Time Frame
week 0, week 12, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
PulseSync
City
Singapore
ZIP/Postal Code
339511
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34620081
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.
Results Reference
derived
Links:
URL
http://www.gymtonic.sg
Description
Promotional website for the Gym Tonic Programme.

Learn more about this trial

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

We'll reach out to this number within 24 hrs