Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

Conditions
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Sarcopenia, Osteopenia or Osteoporosis

Intervention / Treatment
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* Device: PEMF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEMF arm<br>In this single-arm study, all participants will be assigned to the intervention arm. | Device: PEMF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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