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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
J. Andrew Taylor, Spaulding Rehabilitation Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Other: FES-row-training Other: Arms-only-row training Other: Time Control Not Applicable

Detailed Description:

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

  1. FES-RT 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.

  2. ARMS-ONLY-RT GROUP

    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.

  3. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three intervention groups (Control, AO-Row, and FES-RT) run in parallel
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FES-row-training
Subjects will perform 6 months of FES-row-training.
Other: 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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: J. Andrew Taylor, Ph.D. Spaulding Rehabilitation Hospital/Harvard Medical School
  Study Documents (Full-Text)

Documents provided by J. Andrew Taylor, Spaulding Rehabilitation Hospital:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: J. Andrew Taylor, Director, Cardiovascular Research Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02139436    
Other Study ID Numbers: 1R01HL117037 ( U.S. NIH Grant/Contract )
1R01HL117037 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2014    Key Record Dates
Results First Posted: March 22, 2022
Last Update Posted: March 22, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries