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SarcopeniaNCT05043480

Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

A study testing PEMF in people with Sarcopenia and Osteopenia or Osteoporosis, run by Louis Tee at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 100 years
Conditions the study is for
Sarcopenia, Osteopenia or Osteoporosis
What is being tested?
PEMF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSingapore
Study dates
1 Oct 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 100 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Santhosh Seetharaman, MBBS contact

90302683

mdcsnks@nus.edu.sg

Singapore1 site

  • Alexandra Hospital

    Singapore, 159964

    Santhosh Seetharaman, MBBS

Other trials in Singapore

About this study

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.

Read the 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.

Being tested
PEMF
Medical subject headings
Sarcopenia, Bone Diseases, Metabolic, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05043480
Study groupRoleWhat they receive
PEMF armExperimentalIn this single-arm study, all participants will be assigned to the intervention arm.
Receives: Device: PEMF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower limb strength

    Lower limb strength measurement measured by dynamometer

    Measured: 18 weeks

  2. Handgrip strength

    Handgrip strength measurement measured by dynamometer

    Measured: 18 weeks

  3. Short Physical Performance Battery (SPPB)

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

    Measured: 18 weeks

  4. 6 minute walk test (6MWT)

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

    Measured: 18 weeks

Secondary outcomes (1)

  1. Lean muscle and fat mass

    Lean muscle and fat mass measured by DEXA scan

    Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05043480
Sponsor's protocol ID
2020/01181
Status last verified
Sep 2021
First submitted
31 Aug 2021
Last updated
14 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31518158

  • 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.

    PubMed 32014064

  • 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.

    PubMed 32875708

Questions about this trial

What is this clinical trial studying?

A study testing PEMF in people with Sarcopenia and Osteopenia or Osteoporosis, run by Louis Tee at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Santhosh Seetharaman, MBBS (90302683, mdcsnks@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower limb strength (time frame: 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05043480, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.

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