Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

September 12, 2021 updated by: Louis Tee
This prospective, single-site, single arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteosarcopenia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, single-site, single-arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteo-sarcopenia. For this pilot study, we will recruit 80 participants aged 65 years old and greater with osteo-sarcopenia, to receive PEMF therapy, at 1.5mT, once a week for 10 min to alternate lower limb (10 mins each week) weekly for 16 weeks. Participants will be followed up at baseline, 4, 8 and 12 and 17 weeks. At each follow-up, falls risk will be assessed by Short Physical Performance Battery (SPPB), including 6-minute walk and 5 sit-to-stand tests, Falls Efficacy Scale International (FESI), 3min-NS (3 minute Nutritional Screening) and SARC-F (Strength, Assistance with Walking, Rise from Chair, Climb Stairs and Falls) questionnaires. Muscle strength (hand grip and leg extension) and calf diameter are measured. Blood tests, saliva tests, and DEXA scans will be done at baseline, immediately after first PEMF exposure and week 17 to determine changes in biomarkers for senescence, bone/fat/muscle composition and skeletal muscle mass.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 159964
        • Alexandra Hospital
        • Contact:
          • Santhosh Seetharaman, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 65 years old and above, which corresponds to the geriatric patient population seen at the Healthy Ageing clinics and wards
  2. Diagnosed with primary osteopenia, including primary osteoporosis, by BMD measurements on DEXA scans
  3. Diagnosed with sarcopenia by SARC-F
  4. Willing and able to give written informed consent

Exclusion Criteria:

  1. Presence of metallic implants, pacemakers or insulin pumps
  2. Presence of rheumatological disease (such as osteoarthritis or rheumatoid arthritis)
  3. Presence of secondary osteoporosis (such as hyperparathyroidism, steroid-induced osteoporosis)
  4. Presence of end-stage organ failure, including severe dementia or cancer
  5. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEMF arm
In this single-arm study, all participants will be assigned to the intervention arm.
Device: PEMF
Participants will receive pulsed electromagnetic fields (PEMF) exposure to alternate lower limbs weekly for 16 weeks. Participants will place alternate lower limb into the PEMF machine. Each lower limb will be exposed to 1.5mT magnetic field exposure for 10 mins once a week (total 10 min each week) for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower limb strength
Time Frame: 18 weeks
Lower limb strength measurement measured by dynamometer
18 weeks
Handgrip strength
Time Frame: 18 weeks
Handgrip strength measurement measured by dynamometer
18 weeks
Short Physical Performance Battery (SPPB)
Time Frame: 18 weeks
Validated assessment tool for balance and lower limb strength (Score from 0 to 12)
18 weeks
6 minute walk test (6MWT)
Time Frame: 18 weeks
Distance walked in a time of 6 minutes (units of meters)
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lean muscle and fat mass
Time Frame: 18 weeks
Lean muscle and fat mass measured by DEXA scan
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Tee

Collaborators

National University of Singapore

Investigators

  • Principal Investigator: Santhosh Seetharaman, MBBS, Head of Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 12, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/01181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcopenia

Clinical Trials on PEMF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe