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Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

Primary Purpose

Sarcopenia, Osteopenia or Osteoporosis

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
PEMF
Sponsored by
Louis Tee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

65 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alexandra Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEMF arm

Arm Description

In this single-arm study, all participants will be assigned to the intervention arm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lean muscle and fat mass
Lean muscle and fat mass measured by DEXA scan

Full Information

First Posted
August 31, 2021
Last Updated
September 12, 2021
Sponsor
Louis Tee
Collaborators
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05043480
Brief Title
Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia
Official Title
Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louis Tee
Collaborators
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Osteopenia or Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEMF arm
Arm Type
Experimental
Arm Description
In this single-arm study, all participants will be assigned to the intervention arm.
Intervention Type
Device
Intervention Name(s)
PEMF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lower limb strength
Description
Lower limb strength measurement measured by dynamometer
Time Frame
18 weeks
Title
Handgrip strength
Description
Handgrip strength measurement measured by dynamometer
Time Frame
18 weeks
Title
Short Physical Performance Battery (SPPB)
Description
Validated assessment tool for balance and lower limb strength (Score from 0 to 12)
Time Frame
18 weeks
Title
6 minute walk test (6MWT)
Description
Distance walked in a time of 6 minutes (units of meters)
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Lean muscle and fat mass
Description
Lean muscle and fat mass measured by DEXA scan
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santhosh Seetharaman, MBBS
Phone
90302683
Email
mdcsnks@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santhosh Seetharaman, MBBS
Organizational Affiliation
Head of Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandra Hospital
City
Singapore
ZIP/Postal Code
159964
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santhosh Seetharaman, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31518158
Citation
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.
Results Reference
background
PubMed Identifier
32014064
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.
Results Reference
background
PubMed Identifier
32875708
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.
Results Reference
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Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

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