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

NCT04661618 | Completed

• 1 other identifier: GT/RCT/2018/001
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Muscle Loss; Sarcopenia

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

GT

ACTIVE COMPARATOR

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

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.

Device: Gym Tonic programme and Gym equipment

Interventions

Gym Tonic programme and Gym equipment 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; GT

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PulseSync Pte Ltd: lead
• Singapore Institute of Technology: collaborator

Study Sites (1)

PulseSync

Singapore, 339511, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34620081 DERIVED

Related Links

• Promotional website for the Gym Tonic Programme.

MeSH Terms

Conditions

Frailty; Muscular Atrophy; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Data is anonymized
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised-Control Trial

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 10, 2020
• Study Start: October 10, 2018
• Primary Completion: July 19, 2019
• Study Completion: October 15, 2019
• Last Updated: December 10, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)