Clinical trial NCT05043480: Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia
Official title: Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Osteopenia or Osteoporosis
Lead sponsor: Alexandra Hospital
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2021-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lower limb strength
timeFrame: 18 weeks
measure: Handgrip strength
timeFrame: 18 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: 18 weeks
measure: 6 minute walk test (6MWT)
timeFrame: 18 weeks
Secondary outcomes:
measure: Lean muscle and fat mass
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alexandra Hospital
Study officials:
affiliation: Head of Department
name: Santhosh Seetharaman, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.