Status:
COMPLETED
The Relationship Between Irisin and Bone Health in Individuals With Spinal Cord Injury
Lead Sponsor:
VA Office of Research and Development
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will examine the relationship between circulating irisin and bone health individuals with spinal cord injury. Additionally, this study seeks to examine the influence of muscle fiber type on...
Detailed Description
After spinal cord injury (SCI), the severe sub-lesion bone loss increases lower-limb fracture risk. In addition to mechanical loading, bone homeostasis is mediated by myokines, skeletal muscle secrete...
Eligibility Criteria
Inclusion
- Participants with SCI:
- age 18 years or older
- traumatic SCI at the cervical level 4 or lower that occurred at least 12 months prior to the start of the study
- American Spinal Injury Association Impairment Scale A, B or C
- uses a manual wheelchair as primary means of mobility (30+ hours per week)
- is able to perform a transfer independently to and from a wheelchair
- has adequate strength and upper extremity function to operate an arm ergometer
- Control Participants:
- age and sex-matched to participant with SCI
Exclusion
- Participants with SCI:
- active use of medications which potentially affect bone metabolism, including: parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates, oral glucocorticoids (use for more than 3 months)
- history of fractures or dislocations in the upper extremity from which the participant has not fully recovered
- upper limb pain or injury that interferes with the ability to perform aerobic exercise
- recent hospitalization for any reason (within the past three months)
- history of coronary artery disease, coronary bypass surgery or other cardiorespiratory events or conditions
- likely to experience clinically significant autonomic dysreflexia and/ or orthostatic hypotension in response to vigorous exercise
- endocrinopathy or metabolic disorders of the bone
- e.g. Paget's disease, renal bone disease
- history of allergic reaction to lidocaine
- any other conditions that the person's primary care physician deems is a contraindication to participation in arm ergometry exercise stress testing or vigorous exercise
- pregnant
- participation in another "Greater than Minimal Risk" study.
- Control Participants:
- active use of medications which potentially affect bone metabolism, including: parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates, oral glucocorticoids (use for more than 3 months)
- history of neuromuscular conditions which could influence muscle gene expression
- history of lower body musculoskeletal injuries from which the participant has not fully recovered
- recent hospitalization for any reason (within the past three months)
- history of allergic reaction to lidocaine
- any other conditions that the person's primary care physician deems is a contraindication to the performance of a vastus lateralis muscle biopsy
- pregnant
- participation in another "Greater than Minimal Risk" study
Key Trial Info
Start Date :
May 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05319522
Start Date
May 5 2023
End Date
April 30 2025
Last Update
July 11 2025
Active Locations (1)
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1
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240