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

Study Description
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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 immediate FES-RT, to a time control beginning FES-RT after a 6 month wait, or 6 months of arms-only-RT followed by FES-RT. Measures will be made at baseline and every 3 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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 will wait for 6 months before performing 6 months of FES-row-training.
 Other: 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: FES-row-training
Other: Arms-only-row training


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  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 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.

  4. 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).

  5. 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.


Eligibility Criteria
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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
Contacts and Locations
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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


Contacts
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Contact: Glen Picard, M.A. 617-758-5511 gpicard@partners.org
Contact: David B Estrada 617-758-5507 destrada@partners.org

Locations
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United States, Massachusetts
Spaulding Hospital Cambridge Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Glen Picard, M.A.    617-758-5511    gpicard@partners.org   
Principal Investigator: J. Andrew Taylor, Ph.D.         
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
More Information
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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
Last Update Posted: September 18, 2019
Last Verified: September 2019
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