N/A N=71 Basic Science

Musculoskeletal Plasticity After Spinal Cord Injury

Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT02622295 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Acute Gene Regulation: MSTN — 5.49; 4.76 arbitrary units — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Single-session electrically induced exercise (Behavioral); Electrically-induced exercise training (Behavioral)
Age: Adult · 21+ yrs
Sex: All
Sponsor: Richard K Shields
Primary completion: Nov 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Gene Regulation: MSTN	5.49; 4.76	<0.001 sig
PRIMARY Acute Gene Regulation: PGC1-alpha	5.23; 6.63	<0.001 sig
PRIMARY Acute Gene Regulation: PDK4	6.59; 7.29	<0.001 sig
PRIMARY Acute Gene Regulation: SDHB	7.15; 7.20	0.467
PRIMARY Post-training Gene Regulation: MSTN	5.34; 4.78	<0.001 sig
PRIMARY Post-training Gene Regulation: PGC1-alpha	5.89; 5.90	0.932
PRIMARY Post-training Gene Regulation: PDK4	7.01; 6.87	0.326
PRIMARY Post-training Gene Regulation: SDHB	7.22; 7.26	0.673
PRIMARY Post-training Metabolism: Fasting Glucose	95.5; 97.8	0.539
PRIMARY Post-training Metabolism: Fasting Insulin	20.6; 11.8	0.155
PRIMARY Post-training Metabolism: HOMA Score	2.3; 1.3	0.164
PRIMARY Post-training Bone Turnover: Osteocalcin	6638.5; 6874.1	0.493
SECONDARY Post-training Subject-report Measures: EQ-5D	0.296; 0.265	0.458

Summary

Patients with spinal cord injury (SCI) experience metabolic syndrome, diabetes, obesity, pressure ulcers, and cardiovascular disease at far greater rates than the general population. A rehabilitation method to prevent or reverse the systemic metabolic consequences of SCI is a pressing need. The purpose of this study is to determine the dose of muscle activity that can enhance an oxidative muscle phenotype and improve clinical markers of metabolic health and bone turnover in patients with SCI. The long-term goal of this research is to develop exercise-based interventions to prevent secondary health conditions such as diabetes and to ultimately protect health-related quality of life (QOL). Specific Aim 1: To compare changes in skeletal muscle gene regulation in individuals who receive high frequency (HF) active-resisted stance and low frequency (LF) active-resisted stance for 3 years. Hypothesis 1: The expression of genes regulating skeletal muscle metabolism will support that HF and LF both instigate a shift toward an oxidative muscle phenotype. A novel finding will be that LF is a powerful regulator of oxidative pathways in skeletal muscle. Specific Aim 2: To compare changes in systemic markers of metabolic health and bone turnover in individuals with SCI who receive HF or LF for 3 years. Hypothesis 2: HF and LF will both reduce glucose/insulin levels and HOMA (homeostasis model assessment) score. Secondary Aim: To measure subject-reported QOL using the EQ-5D survey metric. Hypothesis 3: HF and LF subjects will show a trend toward improved self-reported QOL after 3 years. There will be an association between metabolic improvement and improved perception of QOL. These observations will support that this intervention has strong feasibility for future clinical translation.

Eligibility Criteria

Inclusion Criteria

Motor complete SCI (AIS A-B)

Exclusion Criteria

Pressure ulcers
Chronic infection
Lower extremity muscle contractures
Deep vein thrombosis
Bleeding disorder
Recent limb fractures
Any comorbid disease known to affect bone metabolism (such as parathyroid dysfunction)
Pregnancy
Anti-osteoporosis medications
Vitamin D supplements
Metformin or other medications for diabetes.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02622295). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.