Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI

NCT02139436 | Completed Results

• 1 other identifier: 1R01HL117037
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Exercise Capacity at 6 Months

  Volunteers will perform an incremental exercise test of FES- or arms-only rowing to determine maximal oxygen uptake.

  Baseline and 6 months

• Change From Baseline in Visceral Adiposity at 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.

  Baseline, 6 months

• Change From Baseline in Myocardial Structure at 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.

  Baseline and 6 months

• Change From Baseline in Insulin Sensitivity at 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.

  Baseline and 6 months

• Change From Baseline in Blood Lipids at 6 Months

  Blood will be taken via standard venipuncture to measure: total cholesterol.

  Baseline and 6 months

Study Arms (3)

FES-row-training

EXPERIMENTAL

Subjects will perform 6 months of FES-row-training.

Other: FES-row-training

Wait-list time control

OTHER

Subjects perform 6 months of their standard of care

Other: Time Control

Arms-only-row-training

ACTIVE COMPARATOR

Subjects will perform 6 months of arms-only row training

Other: Arms-only-row training

Interventions

FES-row-training OTHER

FES-row-training

Arms-only-row training OTHER

Arms-only-row-training

Time Control OTHER

Wait-list time control

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Spinal cord injured outpatients aged 18-40
• medically stable
• body mass index 18.5-30.0
• months post SCI
• ASIA scale A, B or C at neurological level C5-T12
• able to follow directions
• leg muscles responsive to FES

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Spaulding Hospital Cambridge

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (5)

• Yates BA, Brown R, Picard G, Taylor JA. Improved pulmonary function is associated with reduced inflammation after hybrid whole-body exercise training in persons with spinal cord injury. Exp Physiol. 2023 Mar;108(3):353-360. doi: 10.1113/EP090785. Epub 2023 Jan 9.

  PMID: 36622954 DERIVED

• Ely MR, Schleifer GD, Singh TK, Baggish AL, Taylor JA. Exercise Training Does Not Attenuate Cardiac Atrophy or Loss of Function in Individuals With Acute Spinal Cord Injury: A Pilot Study. Arch Phys Med Rehabil. 2023 Jun;104(6):909-917. doi: 10.1016/j.apmr.2022.12.001. Epub 2022 Dec 23.

  PMID: 36572202 DERIVED

• Solinsky R, Schleifer GD, Draghici AE, Hamner JW, Taylor JA. Methodologic implications for rehabilitation research: Differences in heart rate variability introduced by respiration. PM R. 2022 Dec;14(12):1483-1489. doi: 10.1002/pmrj.12770. Epub 2022 Mar 12.

  PMID: 35077032 DERIVED

• Solinsky R, Draghici A, Hamner JW, Goldstein R, Taylor JA. High-intensity, whole-body exercise improves blood pressure control in individuals with spinal cord injury: A prospective randomized controlled trial. PLoS One. 2021 Mar 4;16(3):e0247576. doi: 10.1371/journal.pone.0247576. eCollection 2021.

  PMID: 33661958 DERIVED

• Ely MR, Singh TK, Baggish AL, Taylor JA. Reductions in Cardiac Structure and Function 24 Months After Spinal Cord Injury: A Cross-Sectional Study. Arch Phys Med Rehabil. 2021 Aug;102(8):1490-1498. doi: 10.1016/j.apmr.2021.01.070. Epub 2021 Feb 5.

  PMID: 33556347 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Flowering time control protein FCA, Arabidopsis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Glen Picard
• Organization: Spaulding Rehabilitation Hospital

gpicard@partners.org

6177585511

Study Officials

• J. Andrew Taylor, Ph.D.

  Spaulding Rehabilitation Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiovascular Research Laboratory

Model Details: Three intervention groups (Control, AO-Row, and FES-RT) run in parallel

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 15, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: March 22, 2022
• Results First Posted: March 22, 2022

Record last verified: 2022-02

Locations

US (1)