N/A
N=68
Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02139436 ↗Enrolled (actual)
68
Serious AEs
2.9%
Results posted
Mar 2022
Primary outcome: Primary: Change From Baseline in Exercise Capacity at 6 Months — 14.6; 18.5; 17.1; 13.9 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FES-row-training (Other); Arms-only-row training (Other); Time Control (Other)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Exercise Capacity at 6 Months |
14.6; 18.5; 17.1; 13.9; 18.2; 18.9 | — |
| PRIMARY Change From Baseline in Visceral Adiposity at 6 Months |
13649; 10503; 10945; 16057; 11247; 12197 | — |
| PRIMARY Change From Baseline in Myocardial Structure at 6 Months. |
136; 149; 143; 129; 133; 138 | — |
| PRIMARY Change From Baseline in Insulin Sensitivity at 6 Months. |
2.7; 0.9; 1.4; 3.1; 0.6; 1.7 | — |
| PRIMARY Change From Baseline in Blood Lipids at 6 Months |
170; 157; 158; 171; 141; 149 | — |
Summary
Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first year, there are profound declines in physiologic function, forming the underlying substrate for future cardiovascular disease . In fact, acquired cardiovascular disease is an increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in part from profound physiologic 'detraining' resulting from motor impairment and immobility. Currently, effective interventions preventing acute declines that lead to cardiovascular compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is challenging and when employed, is typically limited to the upper body. Recently, the investigators refined a unique form of exercise for those with SCI that specifically mirrors exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in a hemodynamic profile that produces the beneficial cardiac loading conditions of large muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate cardiovascular declines following SCI. The investigators aims are to test the overall hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function, and 3) counter ventricular wall thickening and declining ventricular function occurring with acute SCI, and that these effects will be greater than that observed with an arms-only exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to FES-RT, to a time control, or arms-only-RT. Measures will be made at baseline and 6 months. The investigators work will provide results that clearly delineate potential health benefits of FES-RT, and if FES-RT is effective in a majority of those with SCI, its application, implementation, and integration could be easily replicated.
Eligibility Criteria
Inclusion Criteria
- Spinal cord injured outpatients aged 18-40
- medically stable
- body mass index 18.5-30.0
- 3-12 months post SCI
- ASIA scale A, B or C at neurological level C5-T12
- able to follow directions
- leg muscles responsive to FES
Exclusion Criteria
- hypertension
- significant arrhythmias
- coronary artery disease
- diabetes
- renal disease
- cancer
- epilepsy
- current use of cardioactive medications
- current grade 2 or greater pressure ulcers at relevant contact sites
- other neurological disease
- peripheral nerve compressions or rotator cuff tears that limit ability to row
- history of bleeding disorder
Data sourced from ClinicalTrials.gov (NCT02139436). 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.