FES Cycling and Nutritional Counseling for Battling Obesity After SCI

NCT03810963 | Completed

• 1 other identifier: WilliamCareyU
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

High intensity interval training; functional electrical stimulation cycling; chronic spinal cord injury; cardiometabolic disease risk; body composition; body fat percentage; nutritional counseling

Outcome Measures

Primary Outcomes (4)

• Body Fat Percentage

  Percentage of body fat measured during pre- and post-testing

  Eight Weeks

• Fat mass and lean mass

  Total fat and lean mass in kg measured during pre- and post-testing

  Eight Weeks

• Arterial health via flow mediated dilation

  Measurement of arterial diameter change in mm after blood flow restriction during pre- poste testing

  Eight Weeks

• Blood glucose testing

  Using finger stick blood droplet method pre- and post-testing for blood glucose and HbA1c measures

  8 weeks

Secondary Outcomes (1)

• Pre- post- intervention three day dietary recall

  Eight Weeks

Study Arms (2)

FES Cycling and Nutrition Counseling

EXPERIMENTAL

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

Nutritional Counseling Only

OTHER

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

Other: Nutritional Counseling Only

Interventions

HIIT-FES Cycling combined with Nutritional Counseling COMBINATION_PRODUCT

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.

FES Cycling and Nutrition Counseling

Nutritional Counseling Only OTHER

Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.

Nutritional Counseling Only

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

Sponsors & Collaborators

• William Carey University: lead
• University of Southern Mississippi: collaborator
• University of Mississippi Medical Center: collaborator

Study Sites (1)

William Carey University Physical Therapy Program

Hattiesburg, Mississippi, 39401, United States

Location

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MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• David Dolbow, DPT, PhD

  William Carey University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 22, 2019
• Study Start: May 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)