Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI
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|ClinicalTrials.gov Identifier: NCT02139436|
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : March 22, 2022
Last Update Posted : March 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Other: FES-row-training Other: Arms-only-row training Other: Time Control||Not Applicable|
We will enroll approximately 60 individuals within three to six months post SCI to obtain data on 50 individuals. One-half of the subjects (N=25) will be randomized to immediately enroll in 6 months of FES-RT. One third (N=18) will be randomized to a wait-list to provide time control data from baseline to 6 months. A wait-list control group is routine in exercise studies because most volunteers are interested in participating in an exercise program. Hence, time controls are difficult to capture since many of those randomized to receive no exercise either drop from the study entirely, or end up pursuing some form of exercise on their own. Therefore, a vehicle for enrollment of a time control group that is acceptable to most volunteers is a wait-list. Therefore, a six month time control will provide data on expected declines and then subjects will be randomized to six months exercise.
Training Protocols for Each Study Group
Subjects will begin with short intervals of FES-RT interspersed with rest intervals and/or arms-only rowing intervals depending on fitness level and the response to the FES. A maximum FES-rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. The goal is for each volunteer to achieve an exercise intensity of 75-85% maintained for a continuous 30 minutes performed three times each week. A maximum FES-rowing test will be performed at the end of the six months of FES-RT to determine increases in fitness.
Training sessions will be 3 times per week for 26 weeks. To parallel the FES-RT, the initial training sessions will also consist of 6 sets of arms-only rowing for five minutes at 60% of VO2peak with a work-to-rest ratio of 2:1 and progress over the six months to an exercise intensity of 75-85% maintained for 30 minutes performed three times each week. A maximum arms-only rowing test will be performed at baseline. This will be repeated after three months of training and training intensity will be adjusted to maintain the training stimulus at the same relative intensity. A maximum arms-only rowing test will be performed at the end of the six months of training to determine increases in fitness.
- WAIT-LIST GROUP
The wait list group will not participate in any training for 6 months. A maximum arms-only rowing test will be performed immediately after enrollment, after initial familiarization with arms-only-RT equipment (usually 2-3 sessions) and will be repeated after 3 and 6 months
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Three intervention groups (Control, AO-Row, and FES-RT) run in parallel|
|Masking:||None (Open Label)|
|Official Title:||Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 1, 2020|
|Actual Study Completion Date :||March 1, 2021|
Subjects will perform 6 months of FES-row-training.
Wait-list time control
Subjects perform 6 months of their standard of care
Other: Time Control
Active Comparator: Arms-only-row-training
Subjects will perform 6 months of arms-only row training
Other: Arms-only-row training
- Change From Baseline in Exercise Capacity at 6 Months [ Time Frame: Baseline and 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 6 Months. [ Time Frame: Baseline and 6 months ]Echocardiography was 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 6 Months. [ Time Frame: Baseline and 6 months ]Blood will be taken via standard venipuncture to measure the homeostasis model assessment of insulin resistance (HOMA-IR). HOMA-IR is a measure of insulin resistance/sensitivity calculated by multiplying fasting insulin (μU/mL) by fasting glucose (mg/dL) and divided by a constant (405). A higher value indicates higher insulin resistance.
- Change From Baseline in Blood Lipids at 6 Months [ Time Frame: Baseline and 6 months ]Blood will be taken via standard venipuncture to measure: total cholesterol.
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
|United States, Massachusetts|
|Spaulding Hospital Cambridge|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||J. Andrew Taylor, Ph.D.||Spaulding Rehabilitation Hospital/Harvard Medical School|