N/A N=89 Basic Science

Long Duration Activity and Metabolic Control After Spinal Cord Injury

Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT03139344 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Acute Gene Regulation: NR4A3 mRNA Expression Pre and Post-Stimulation — 3.235; 2.711; 6.286; 5.772 arbitrary units — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Low-frequency Exercise (Other); High-frequency Exercise (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Richard K Shields
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Acute Gene Regulation: NR4A3 mRNA Expression Pre and Post-Stimulation	3.235; 2.711; 6.286; 5.772	<0.001 sig
PRIMARY Acute Gene Regulation: PGC1-alpha mRNA Expression Pre and Post-Stimulation	5.37; 4.92; 6.72; 6.43	<0.001 sig
PRIMARY Acute Gene Regulation: ABRA mRNA Expression Pre and Post-Stimulation	6.76; 5.63; 8.61; 7.71	0.011 sig
PRIMARY Acute Gene Regulation: PDK4 mRNA Expression Pre and Post-Stimulation	6.64; 6.46; 7.23; 7.45	0.148
PRIMARY Post-training Gene Regulation: MYH6 mRNA Expression Baseline and Post-Training	6.61; 5.38; 7.10; 6.58	0.069
PRIMARY Post-training Gene Regulation: MYL3 mRNA Expression Baseline and Post-Training	7.37; 6.38; 8.01; 7.96	0.118
PRIMARY Post-training Gene Regulation: MYH7 mRNA Expression Baseline and Post-Training	8.55; 7.16; 9.43; 8.85	0.059
PRIMARY Post-training Gene Regulation: ACTN3 mRNA Expression Baseline and Post-Training	8.95; 8.51; 8.20; 7.12	0.010 sig
PRIMARY Post-training Metabolism: Fasting Insulin	19.245; 8.305	0.036 sig
PRIMARY Post-training Metabolism: Fasting Glucose	94.727; 91.091	0.345
PRIMARY Post-training Metabolism: Fasting Glucose-insulin Ratio	8.649; 11.274	0.264
PRIMARY Post-training Metabolism: Fasting Hemoglobin A1c (HBA1c)	4.227; 3.970	0.266
PRIMARY Post-training Metabolism: C-reactive Protein (CRP)	11.427; 4.545	0.040 sig
PRIMARY Pre-training Subject-report Measures: PROMIS Physical Health	39.9; 37.0	0.109
PRIMARY Pre-training Subject Report Measures: PROMIS Mental Health	47.0; 47.3	0.895
PRIMARY Post-training Subject-report Measures: PROMIS Physical Health	39.9; 39.5	0.573
PRIMARY Post-training Subject-report Measures: PROMIS Mental Health	47.0; 47.3	0.858

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.

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, pregnancy, metformin or other medications for diabetes

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03139344). 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.