Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

Sarcopenia Clinical Trial

Official title:

Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05043480
• Other study ID #: 2020/01181
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Alexandra Hospital
• Contact: Santhosh Seetharaman, MBBS
• Phone: 90302683
• Email: mdcsnks[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteoporosis
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Singapore	Alexandra Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Louis Tee	National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Kurth F, Tai YK, Parate D, van Oostrum M, Schmid YRF, Toh SJ, Yap JLY, Wollscheid B, Othman A, Dittrich PS, Franco-Obregón 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. — View Citation

Parate D, Kadir ND, Celik C, Lee EH, Hui JHP, Franco-Obregón 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. — View Citation

Yap JLY, Tai YK, Fröhlich 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-Obregón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower limb strength	Lower limb strength measurement measured by dynamometer	18 weeks
Primary	Handgrip strength	Handgrip strength measurement measured by dynamometer	18 weeks
Primary	Short Physical Performance Battery (SPPB)	Validated assessment tool for balance and lower limb strength (Score from 0 to 12)	18 weeks
Primary	6 minute walk test (6MWT)	Distance walked in a time of 6 minutes (units of meters)	18 weeks
Secondary	Lean muscle and fat mass	Lean muscle and fat mass measured by DEXA scan	18 weeks