The Relationship Between Irisin and Bone Health in Individuals With Spinal Cord Injury

NCT05319522 | Completed

• 1 other identifier: B3641-M
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 circulating irisin and identify an exercise-based means to increase irisin concentrations.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injuries; Irisin; Bone mineral density; Exercise

Outcome Measures

Primary Outcomes (3)

• Irisin - Bone measure correlations

  Circulating irisin concentrations will be correlated with DXA and HR-pQCT bone measures

  Baseline; at rest

• FNDC5 gene expression

  FNDC5 gene expression will be measured in vastus lateralis skeletal muscle biopsies via RT-PCR to determine if potential differences in circulating irisin concentrations may be attributed to differential gene expression.

  Baseline; at rest

• Exercise induced change in irisin concentration

  Circulating irisin concentrations will be measured before and immediately following an arm ergometer high-intensity interval exercise bout to determine if this exercise modality can increased circulating irisin concentrations in individuals with SCI and controls

  baseline and immediately post-exercise

Study Arms (2)

Individuals with SCI

ACTIVE COMPARATOR

Male and female, Veteran and non-Veteran participants with traumatic SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.

Behavioral: Acute Exercise

Controls (No SCI)

ACTIVE COMPARATOR

Male and female Veterans, age and sex-matched to participants with SCI will complete the baseline blood draw, muscle biopsy and DXA/HR-pQCT bone imaging. This group will complete blood draws before and after arm ergometer high-intensity interval exercise bout.

Behavioral: Acute Exercise

Interventions

Acute Exercise BEHAVIORAL

Participants with and without SCI will complete an arm ergometer, high-intensity interval exercise bout. The exercise bout will be performed at a relative intensity based on previously determined peak power output during an arm ergometer graded exercise test.

Also known as: Arm Ergometer Exercise; High-Intensity Interval Exercise

Controls (No SCI); Individuals with SCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Adam J. Sterczala, PhD

  VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: May 5, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)