Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
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|ClinicalTrials.gov Identifier: NCT02139436|
Recruitment Status : Recruiting
First Posted : May 15, 2014
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Other: FES-row-training Other: Arms-only-row training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
Subjects will perform 6 months of FES-row-training.
Wait-list time control
Subjects will wait for 6 months before performing 6 months of FES-row-training.
Active Comparator: Arms-only-row-training
Subjects will perform 6 months of arms-only row training followed by 6 months of FES-row-training
Other: Arms-only-row training
- Change from baseline in exercise capacity at 3 and 6 months [ Time Frame: Baseline, 3 months, 6 months ]Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake.
- Change from baseline in visceral adiposity at 6 months [ Time Frame: Baseline, 6 months ]We will use a 5th generation General Electric Healthcare dual x-ray absorptiometry(DXA) scanner for regional fat measurements, the DXA software can be used to define standard regions that will allow comparability of measurements throughout the study.
- Change from baseline in myocardial structure at 3 and 6 months. [ Time Frame: Baseline, 3months, 6 months ]Echocardiography will be performed using a commercially available system(Vivid-1, General Electric Healthcare)to obtain measures of left ventricular wall thickness and left ventricular diastolic function.
- Change from baseline in insulin sensitivity at 3 and 6 months. [ Time Frame: Baseline, 3 months, 6 months ]Blood will be taken via standard venipuncture to measure: the homeostasis model assessment(HOMA) of insulin resistance, the quantitative insulin check index(QUICKI) and the serum insulin-like growth factor binding protein-1(IGFBP-1).
- Change from baseline in serum lipids at 3 and 6 months [ Time Frame: Baseline, 3 months, 6 months ]Blood will be taken via standard venipuncture to measure: plasma total cholesterol, low density cholesterol, high density apolipoprotein lipids and triglycerides.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139436
|Contact: Glen Picard, M.A.||email@example.com|
|Contact: David B Estradafirstname.lastname@example.org|
|United States, Massachusetts|
|Spaulding Hospital Cambridge||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Glen Picard, M.A. 617-758-5511 email@example.com|
|Principal Investigator: J. Andrew Taylor, Ph.D.|
|Principal Investigator:||J. Andrew Taylor, Ph.D.||Spaulding Rehabilitation Hospital/Harvard Medical School|