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Completed

NCT Number: NCT04661618

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

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.

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Key information

Conditions

Frailty Atrophy Muscle Loss Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PulseSync

Singapore, 339511

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Sponsors and collaborators

Lead sponsor

PulseSync Pte Ltd

Industry

Collaborators

  • Singapore Institute of Technology

Registry information

Official study title

A Randomized-Control Study of Gym Tonic's Community Based Strength Training Intervention on Physical Function and Frailty Reversal, for Elderly Singaporeans.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2020
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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