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

NCT ID: NCT04661618

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2019-10-15

Brief Summary

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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

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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

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Frailty Muscle Loss Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised-Control Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Data is anonymized

Study Groups

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GT

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

Group Type ACTIVE_COMPARATOR

Gym Tonic programme and Gym equipment

Intervention Type DEVICE

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

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.

Group Type OTHER

Gym Tonic programme and Gym equipment

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Singapore Institute of Technology

OTHER

Sponsor Role collaborator

PulseSync Pte Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PulseSync

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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.

Reference Type DERIVED
PMID: 34620081 (View on PubMed)

Related Links

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http://www.gymtonic.sg

Promotional website for the Gym Tonic Programme.

Other Identifiers

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GT/RCT/2018/001

Identifier Type: -

Identifier Source: org_study_id