FrailtyNCT04661618
A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention.
A study testing Gym Tonic programme and Gym equipment in people with Frailty and Muscle Loss, run by PulseSync Pte Ltd at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Muscle Loss, Sarcopenia
- What is being tested?
- Gym Tonic programme and Gym equipment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Oct 2018to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Bedbound
- Terminally ill patients with life expectancy <12 months
- Significant cognitive impairment
- Major depression
- Wear pacemaker
- Severe audiovisual impairment
Show all 9Show fewer
- Any progressive, degenerative neurologic disease
- Participating in other interventional studies
- Unavailable to participate for the full duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Frailty, Muscle Loss, Sarcopenia
- Being tested
- Gym Tonic programme and Gym equipment
- Medical subject headings
- Frailty, Muscular Atrophy, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gym Tonic programme and Gym equipmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| GT | Active comparator | 12 weeks of progressive training in the first phase and 12 weeks of maintenance training in the second phase. Receives: Device: Gym Tonic programme and Gym equipment |
| Control | Other | 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. Receives: Device: Gym Tonic programme and Gym equipment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Isometric Muscle Strength (Knee Extension)
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 0, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start10 Oct 2018
- Primary completion19 Jul 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised-Control Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseSync Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Singapore Institute of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661618
- Sponsor's protocol ID
- GT/RCT/2018/001
- Status last verified
- Dec 2020
- First submitted
- 19 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention on Physical Function and Frailty Reversal, for Elderly Singaporeans.
- ClinicalTrials.gov ID
- NCT04661618
- Acronym / sponsor ID
- GT/RCT/2018/001
- Conditions
- Frailty, Muscle Loss, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- PulseSync Pte LtdIndustry (pharma, biotech, devices)
- Collaborators
- Singapore Institute of Technology
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomised-Control Trial
| Arm | Type | Receives |
|---|---|---|
| GT | Active comparator | Device: Gym Tonic programme and Gym equipment12 weeks of progressive training in the first phase and 12 weeks of maintenance training in the second phase. |
| Control | Other | Device: Gym Tonic programme and Gym equipmentNo 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Bedbound
- Terminally ill patients with life expectancy <12 months
- Significant cognitive impairment
- Major depression
- Wear pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gym Tonic programme and Gym equipment12 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 | Device | Control, GT |
Primary outcome
Change in Isometric Muscle Strength (Knee Extension)
Time frame: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Change in Isometric Muscle Strength (Knee Flexion)
Time frame: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the right and left leg.
Change in Isometric Muscle Strength (Hip Abduction)
Time frame: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
Change in Isometric Muscle Strength (Hip Adduction)
Time frame: week 0, week 12, week 24
Measured via isometric performance recorder fixed to exercise machine for the above mentioned movement.
Handgrip Strength
Time frame: week 0, week 12, week 24
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)
Time frame: week 0, week 12, week 24
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
Time frame: week 0, week 12, week 24
To balance in the said position for 10 seconds. Scored point will be determined by number of seconds held.
SPPB Balance Test - Tandem stand
Time frame: week 0, week 12, week 24
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
Time frame: week 0, week 12, week 24
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)
Time frame: week 0, week 12, week 24
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)
Time frame: week 0, week 12, week 24
To walk 4 metres at participant's fastest speed, scored point will be determined based on time taken to complete the 4-Metre walk.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Derived from this study: PubMed 34620081Lee 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.
- Promotional website for the Gym Tonic Programme.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gym Tonic programme and Gym equipment in people with Frailty and Muscle Loss, run by PulseSync Pte Ltd at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Isometric Muscle Strength (Knee Extension) (time frame: week 0, week 12, week 24). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2020; AzTrials last refreshed its copy on 31 Oct 2026.