A Randomized Controlled Trial Comparing Whole Body Vibration Therapy With Usual Care and Usual Care to Improve Muscle Health in Older Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorChangi General Hospital

About this trial

This study is a randomized controlled trial where participants would be randomly assigned to one of 2 groups. One group would receive Whole body vibration therapy and usual care and the other group only usual care. Measurements of muscle mass, strength and function would be taken before the interventions, and at 2 other points after interventions. Differences in the outcomes between the two groups would be analysed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy Volunteer or Patients aged 65 and above,

Clinical frailty Scale (CFS) score of 3-4,

Independently ambulating without any aid

willingness and consent to participate in the study and ability to travel to the study-site for the measurements and interventions, and

Disqualifiers

current active enrolment into any Day Rehab or community exercise program,

contraindications to WBVT machine usage (see below),

diagnosis of dementia,

history of Diabetes Mellitus

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whole Body Vibration Training

    Other intervention

    Information already included in arm/group descriptions.

  • Otago Exercise

    Other intervention

    Usual Care

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Whole Body Vibration TrainingExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Isometric Knee Extension Strength

Measured using a JTech Medical, Northstar Echo Muscle Tester with subject seated with knee flexed at 90 degrees and hanging, muscle tester is placed at the ventral surface of the ankle between malleoli and subject instructed to push against tester with maximal effort to extend the knee. Best of three trials would be taken.

Time frame
Baseline and 2 weeks after intervention and 3 months after intervention

Secondary outcomes

1

Hand Grip Strength

Measured using Jtech Medical, Northstar Echo Grip hand dynamometer with participant sitting upright with elbows flexed at 90 degrees and arms unsupported, best of 3 tries from each hand.

Time frame
Baseline and at 2 weeks post intervention and 3 months post intervention
2

Appendicular Skeletal Mass Index

Height adjusted Appendicular Skeletal Mass index as measured by the InBody S10 Body Composition Analysis machine

Time frame
Baseline and at 2 weeks post intervention and 3 months post intervention
3

Gait Speed

6 metres normal gait speed (metres/second)

Time frame
Baseline and at 2 weeks post intervention and 3 months post intervention
4

5-timed chair stands

Time taken to perform 5 chair stands with both arms crossed over chest (seconds)

Time frame
Baseline and at 2 weeks post intervention and 3 months post intervention

Other outcomes

1

Participant Surveys

Survey on user experience and satisfaction as well as feasibility, accessibility

Time frame
2 weeks post intervention up to 3 months post intervention
2

Exercise adherence

Participants would be instructed to record their exercise participation in an exercise diary with remarks on any symptoms experienced.

Time frame
During 4 weeks intervention period
3

Semi-structured interviews

Semi-structured interviews would be conducted for the 20 participants in the WBVT (intervention) arm to enhance the qualitative data collected.

Time frame
2 weeks post intervention up to 3 months post intervention

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changi General Hospital

Lead sponsor

BMEC Pte Ltd

Collaborator