CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 71 enrolled
Drug / intervention
Single-session electrically induced exercise +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02622295
NCT02622295N/ACompleted

Musculoskeletal Plasticity After Spinal Cord Injury

Richard K Shields·interventional·Posted Dec 4, 2015·Updated Nov 4, 2022

In Brief

A clinical study evaluating Single-session electrically induced exercise and Electrically-induced exercise training for Spinal Cord Injuries. Completed, enrolled 71 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 4, 2015
Enrollment StartMay 1, 2015
Primary CompletionNov 18, 2021
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 10.6 years ago

Interventions

Single-session electrically induced exercisebehavioral

A single session of electrically induced exercise to the quadriceps and hamstring muscle groups of people with paralysis.

Electrically-induced exercise trainingbehavioral

Multiple sessions of electrically induced exercise to the quadriceps and hamstring muscle groups for up to 3 years in people with paralysis.