Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

Not Applicable

• Conditions: Sarcopenia; Osteopenia or Osteoporosis

• Registration Number: NCT05043480
• Lead Sponsor: Louis Tee

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.

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 Timeline

• Study First Submitted: 2021-08-31
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-12
• Last Update Submitted: 2021-09-12
• Study First Posted: 2021-09-14
• Last Update Posted: 2021-09-14
• Study Start: 2021-10-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Lean muscle and fat mass	18 weeks	Lean muscle and fat mass measured by DEXA scan

Trial Locations

Locations (1)

Alexandra Hospital; 🇸🇬 Singapore, Singapore