CClinicalTrials.gg
CompletedNCT04661618Updated Dec 10, 2020

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

An interventional study of Gym Tonic programme and Gym equipment in Frailty, Muscle Loss and Sarcopenia, sponsored by PulseSync Pte Ltd. Completed at 1 site in Singapore. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-10.

Sponsored by PulseSync Pte Ltd · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Oct 2018, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Frailty
  • Muscle Loss
  • Sarcopenia
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 318 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

This is the only study on the registry with PulseSync Pte Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
318 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceGym 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

06

What researchers measure

Primary outcomes

  1. Change in Isometric Muscle Strength (Knee Extension)

    Measured via isometric performance recorder fixed to exercise machine for the right and left leg.

    Time frame: week 0, week 12, week 24

  2. Change in Isometric Muscle Strength (Knee Flexion)

    Measured via isometric performance recorder fixed to exercise machine for the right and left leg.

    Time frame: week 0, week 12, week 24

  3. Change in Isometric Muscle Strength (Hip Abduction)

    Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.

    Time frame: week 0, week 12, week 24

  4. Change in Isometric Muscle Strength (Hip Adduction)

    Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.

    Time frame: week 0, week 12, week 24

  5. 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.

    Time frame: week 0, week 12, week 24

  6. 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.

    Time frame: week 0, week 12, week 24

  7. 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.

    Time frame: week 0, week 12, week 24

  8. SPPB Balance Test - Tandem stand

    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

  9. 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.

    Time frame: week 0, week 12, week 24

  10. 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.

    Time frame: week 0, week 12, week 24

  11. 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.

    Time frame: week 0, week 12, week 24

07

Study locations

1 site
  • PulseSync
    Singapore, 339511, Singapore
08

References and documents

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. PubMed 34620081 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04661618
Lead sponsor
PulseSync Pte Ltd
Collaborators
Singapore Institute of Technology
Responsible party
Sponsor
First posted
Dec 10, 2020
Start date
Oct 10, 2018
Primary completion
Jul 19, 2019
Completion
Oct 15, 2019
Last update
Dec 10, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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