CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Low-frequency Exercise +1 moreother
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/NCT03139344
NCT03139344N/ACompleted

Long Duration Activity and Metabolic Control After Spinal Cord Injury

Richard K Shields·interventional·Posted May 3, 2017·Updated Feb 16, 2023

In Brief

A clinical study evaluating Low-frequency Exercise and High-frequency Exercise for Spinal Cord Injuries. Completed, enrolled 89 participants across 1 site.

Detailed Summary

Skeletal muscle is the largest endocrine organ in the body, playing an indispensable role in glucose homeostasis. Spinal cord injury (SCI) prevents skeletal muscle from carrying out this important function. Dysregulation of glucose metabolism precipitates high rates of metabolic syndrome, diabetes, and other secondary health conditions (SHCs) of SCI. These SHCs exert a negative influence on health-related quality of life (HRQOL). New discoveries support that a low level of activity throughout the day offers a more effective metabolic stimulus than brief, episodic exercise bouts. The proposed study will translate this emerging concept to the population of individuals with SCI by using low-force, long-duration electrical muscle stimulation to subsidize daily activity levels. Recently, we demonstrated that this type of stimulation up-regulates key genes that foster an oxidative, insulin-sensitive phenotype in paralyzed muscle. We will now test whether this type of activity can improve glucose homeostasis and metabolic function in patients with chronic paralysis. We hypothesize that improvements in metabolic function will be accompanied by a reduction in SHCs and a concomitant improvement in self-reported HRQOL. The long-term goal of this research is to develop a rehabilitation strategy to protect the musculoskeletal health, metabolic function, and health-related quality of life of people living with complete SCI.

Study Details

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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 3, 2017
Enrollment StartAug 1, 2015
Primary CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 9.2 years ago

Interventions

Low-frequency Exerciseother

The quadriceps/hamstrings will perform exercise via the application of low-frequency electrical stimulation.

High-frequency Exerciseother

The quadriceps/hamstrings will perform exercise via the application of high-frequency electrical stimulation.