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 : April 18, 2018
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139436
|Contact: Glen Picard, M.A.||firstname.lastname@example.org|
|Contact: David B Estradaemail@example.com|
|United States, Massachusetts|
|Spaulding Hospital Cambridge||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Glen Picard, M.A. 617-758-5511 firstname.lastname@example.org|
|Principal Investigator: J. Andrew Taylor, Ph.D.|
|Principal Investigator:||J. Andrew Taylor, Ph.D.||Spaulding Rehabilitation Hospital/Harvard Medical School|