NCT05043480

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

August 31, 2021

Last Update Submit

September 12, 2021

Conditions

SarcopeniaOsteopenia or Osteoporosis

Outcome Measures

Primary Outcomes (4)

  • Lower limb strength

    Lower limb strength measurement measured by dynamometer

    18 weeks

  • Handgrip strength

    Handgrip strength measurement measured by dynamometer

    18 weeks

  • Short Physical Performance Battery (SPPB)

    Validated assessment tool for balance and lower limb strength (Score from 0 to 12)

    18 weeks

  • 6 minute walk test (6MWT)

    Distance walked in a time of 6 minutes (units of meters)

    18 weeks

Secondary Outcomes (1)

  • Lean muscle and fat mass

    18 weeks

Study Arms (1)

PEMF arm

EXPERIMENTAL

In this single-arm study, all participants will be assigned to the intervention arm.

Device: PEMF

Interventions

PEMFDEVICE

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.

PEMF arm

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandra Hospital

Singapore, 159964, Singapore

Location

Related Publications (3)

  • Yap JLY, Tai YK, Frohlich J, Fong CHH, Yin JN, Foo ZL, Ramanan S, Beyer C, Toh SJ, Casarosa M, Bharathy N, Kala MP, Egli M, Taneja R, Lee CN, Franco-Obregon A. Ambient and supplemental magnetic fields promote myogenesis via a TRPC1-mitochondrial axis: evidence of a magnetic mitohormetic mechanism. FASEB J. 2019 Nov;33(11):12853-12872. doi: 10.1096/fj.201900057R. Epub 2019 Sep 13.

    PMID: 31518158BACKGROUND

  • Parate D, Kadir ND, Celik C, Lee EH, Hui JHP, Franco-Obregon A, Yang Z. Pulsed electromagnetic fields potentiate the paracrine function of mesenchymal stem cells for cartilage regeneration. Stem Cell Res Ther. 2020 Feb 3;11(1):46. doi: 10.1186/s13287-020-1566-5.

    PMID: 32014064BACKGROUND

  • Kurth F, Tai YK, Parate D, van Oostrum M, Schmid YRF, Toh SJ, Yap JLY, Wollscheid B, Othman A, Dittrich PS, Franco-Obregon A. Cell-Derived Vesicles as TRPC1 Channel Delivery Systems for the Recovery of Cellular Respiratory and Proliferative Capacities. Adv Biosyst. 2020 Nov;4(11):e2000146. doi: 10.1002/adbi.202000146. Epub 2020 Sep 2.

    PMID: 32875708BACKGROUND

MeSH Terms

Conditions

SarcopeniaBone Diseases, MetabolicOsteoporosis

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Santhosh Seetharaman, MBBS

    Head of Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Santhosh Seetharaman, MBBS

CONTACT

90302683mdcsnks@nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Resident

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 14, 2021

Study Start

October 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)