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FES Cycling and Nutritional Counseling for Battling Obesity After SCI

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ClinicalTrials.gov Identifier: NCT03810963
Recruitment Status : Completed
First Posted : January 21, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
University of Southern Mississippi
University of Mississippi Medical Center
Information provided by (Responsible Party):
David Dolbow, William Carey University

Brief Summary:
Individuals who suffer from paralysis after spinal cord injury (SCI) are estimated to have an even greater (66%) prevalence of obesity. Obesity is a major public health concern and is associated with a plethora of cardiometabolic health complications (heart disease, stroke and type II diabetes mellitus). Although the benefits of physical activity to counteract obesity and cardiometabolic disease have been documented, SCI typically limits voluntary exercise to the often injured arms (60-90%). On the other hand, functional electrical stimulation (FES) cycling has proven to be a safe and effective way to exercise paralyzed leg muscles in clinical and home settings, saving the often overworked arms. The investigators have developed a novel high-intensity interval training (HIIT) protocol for FES lower extremities cycling that may provide equal or greater benefits with less time commitment. The investigators proof-of-principle study in 3 obese persons with SCI confirmed that HIIT-FES cycling 3 times per week for 8 weeks without dietary monitoring can increase legs lean mass (5-9%), increase cardiovascular health markers (58% on average) and decrease HbA1c blood levels (2-4%). Also, 2 persons decreased body weight and BMI. The investigators hypothesize that combining HIIT-FES cycling with nutritional counseling will be effective for reducing obesity and enhancing cardiometabolic health in persons with chronic SCI. Research AIM: To determine preliminary efficacy of HIIT-FES cycling combined with nutritional counseling in obese adults with SCI. In this pilot two-arm, parallel, pre-post, subject-matched controlled trial, we will test the hypothesis that the experimental group receiving HIIT-FES cycling plus nutritional counseling will decrease total body weight, decrease body fat percentage, decrease fat mass, increase total and legs lean mass, improve blood lipid levels, decrease blood glucose and HbA1c levels and improve vascular endothelial health (flow mediated dilation) significantly more than age-, sex- and injury-matched controls receiving nutritional counseling only. The investigators will recruit 20 obese adults, 21-65 years of age, with chronic post-traumatic SCI ranging in neurological level between C4 and T12. Participants will be divided into experimental (HIIT-FES cycling plus nutritional counseling) and control (nutritional counseling only) groups.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Combination Product: HIIT-FES Cycling combined with Nutritional Counseling Other: Nutritional Counseling Only Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The hypothesis for our research aim is that combining RG-HIIT-FES cycling with nutritional counseling will be more effective than nutritional counseling alone for reducing obesity and enhancing cardiometabolic health markers in persons with chronic SCI. This will be tested using a subject-matched controlled pre-post design. The experimental group receives 30 minutes of RG-HIIT-FES cycling three times per week for eight weeks and nutritional counseling over the telephone for 30 minutes one time per week for eight weeks. The control group receives the nutritional counseling only.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electrically Induced Cycling and Nutritional Counseling for Counteracting Obesity After SCI
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FES Cycling and Nutrition Counseling

Device:

HIIT-FES cycling will be performed 30 minutes per session, 3 times per week for 3 weeks combined with

Behavior:

Nutrition counseling will be completed via telephone for 30 minutes once per week for 8 weeks.

Combination Product: HIIT-FES Cycling combined with Nutritional Counseling
High intensity interval training functional electrical stimulation cycling for 30 minutes, three days per week for eight weeks, Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.

Nutritional Counseling Only

Behavior:

Nutritional counseling will be completed via telephone for 30 minutes once per week for 8 weeks.

Other: Nutritional Counseling Only
Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.




Primary Outcome Measures :
  1. Body Fat Percentage [ Time Frame: Eight Weeks ]
    Percentage of body fat measured during pre- and post-testing

  2. Fat mass and lean mass [ Time Frame: Eight Weeks ]
    Total fat and lean mass in kg measured during pre- and post-testing

  3. Arterial health via flow mediated dilation [ Time Frame: Eight Weeks ]
    Measurement of arterial diameter change in mm after blood flow restriction during pre- poste testing

  4. Blood glucose testing [ Time Frame: 8 weeks ]
    Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures


Secondary Outcome Measures :
  1. Pre- post- intervention three day dietary recall [ Time Frame: Eight Weeks ]
    Prior to and after the intervention a 3 day dietary recall will be completed to determine changes in dietary habits.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We will recruit men and women with C4-T12 SCI (n=20) American Spinal Injury Association Impairment Scale A, B, or C as per International Standards for Neurological Classification of SCI; ≥2 years post-SCI; age 21-65 years; body fat percentage according to over-weight classifications detailed in Gallagher et al. Am J Clin Nut 2000,72:694-701 ( women 20-40 y/o > 30%, 41-60 y/o > 35%, > 60 y/o > 42%; men 20-40 y/o > 19%, 40-60 y/o > 22%, > 60 y/o > 25%).

Exclusion Criteria:

  • Exclusion criteria include pressure wounds on buttocks or feet; unhealed bone fractures or history of fragility fractures; uncontrolled cardiovascular or metabolic disease; severe osteoporosis (T score ≤ 4); uncontrolled autonomic dysreflexia; and current smokers.

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): NCT03810963


Locations
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United States, Mississippi
William Carey University Physical Therapy Program
Hattiesburg, Mississippi, United States, 39401
Sponsors and Collaborators
William Carey University
University of Southern Mississippi
University of Mississippi Medical Center
Investigators
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Principal Investigator: David Dolbow, DPT, PhD William Carey University

Publications of Results:

Other Publications:
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Responsible Party: David Dolbow, Associate Professor of Physical Therapy, William Carey University
ClinicalTrials.gov Identifier: NCT03810963     History of Changes
Other Study ID Numbers: WilliamCareyU
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: None currently

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Dolbow, William Carey University:
High intensity interval training
functional electrical stimulation cycling
chronic spinal cord injury
cardiometabolic disease risk
body composition
body fat percentage
nutritional counseling
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