Hybrid HIIT-FES Cycling Program on Individuals With Spinal Cord Injury to Improve Health

NCT07648173 | Recruiting DMC

• 1 other identifier: WilliamCareyUn
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Project Summary/Abstract Obesity and metabolic syndrome (obesity, dyslipidemia, hyperglycemia, hypertension) are epidemic in the spinal cord injured (SCI) population. A recent study assessing the body composition and metabolic syndrome rates of 72 motor complete chronic SCI individuals revealed an obesity rate of over 90% and a metabolic syndrome rate of 60%. These results are significantly higher than in the general population. As such individuals with SCI typically have systemic inflammation and an accelerated trajectory towards cardiometabolic disease, and early mortality. Although the accelerated trajectory is multi-factorial, substantial evidence implicates sedentary behavior and low physical activity levels as significant contributing factors. Exercise strategies for individuals with SCI have included upper body arm crank exercise (ACE), functional electrical stimulation leg cycling exercise (FES-LCE), or a combination of the two (FES Hybrid Exercise). These modalities have yielded modest improvements in physical fitness and cardiometabolic risk profiles in individuals with SCI. FES-LCE reportedly increased lean-to-fat mass ratio, enhanced peripheral blood flow and vasoreactivity, and increased bone mass in the paralyzed legs. In addition, FES-LCE improves metabolic function as evidenced by increased glucose disposal. There is evidence that high-intensity interval training exercise can increase muscle mass and improve cardiovascular fitness with considerably less time commitment than non-interval activities. However, given many individuals with SCI respond poorly to the onset of training a primer exercise program for the extremely deconditioned muscles is recommended for optimal results. The investigators intend to investigate the optimization of benefits by using a novel hybrid FES cycling protocol (FES legs cycling plus voluntary arms cycling) combined with high intensity interval training (HIIT) and preceded by a preparatory muscle strengthening program called "peripheral remodeling intermittent muscular exercise (PRIME) to prepare the deconditioned muscles for the more intense exercise in the hybrid HIIT-FES cycling program. The investigators hypothesize that individuals in the PRIME + hybrid HIIT-FES cycling program will demonstrate significantly greater cardiometabolic health and functional benefits than the control group receiving standard of care range of motion exercises.

Conditions

Spinal Cord Injuries

Keywords

Hybrid functional electrical stimulation cycling

Outcome Measures

Primary Outcomes (7)

• Aerobic Fitness

  Vo2peak determined by arm crank maximal exercise stress test

  12 weeks

• Percent body fat

  Percent body fat determined by DXA scan.

  12 weeks

• Percent lean mass

  Percent and amount of lean mass (muscle and bone) determined by DXA scan.

  12 weeks

• Lipid profile

  Blood testing of high density lipoprotein

  12 weeks

• Glucose profile

  Blood test for fasting glucose.

  12 weeks

• Inflammation marker

  Blood test for c-reactive protein

  12 weeks

• Functional mobility

  Ten meter wheelchair propulsion test

  12 weeks

Study Arms (2)

Muscle strengthening exercise and hybrid FES cycling

EXPERIMENTAL

Voluntary muscle strengthening includes wall pulley exercises (seated rows and chest press for arms, 4 sets of 10 reps twice weekly for four weeks followed by the hybrid FES cycling which includes arm cycling (HIIT 2 minutes easy alternated with 2 hard for 20 -30 minutes using Borg 10 point rating of perceived exertion scale twice weekly for eight weeks.

Other: Muscle strengthening exercise followed by Hybrid FES cycling Exercise; Other: Active ROM exercise with arms and Passive ROM exercise with legs

Active range of motion exercise with the arms 4x10 reps and passive range of motion to legs 4x10.

ACTIVE COMPARATOR

Active range of motion (arms) and passive range of motion exercises with the legs is considered a standard of care comparison. Both arms and legs will receive 4 sets of 10 repetitions twice weekly for 12 weeks.

Other: Muscle strengthening exercise followed by Hybrid FES cycling Exercise; Other: Active ROM exercise with arms and Passive ROM exercise with legs

Interventions

Muscle strengthening exercise followed by Hybrid FES cycling Exercise OTHER

Resistance exercise with arms and electrical stimulation to legs (4 sets of 10 repetitions twice weekly for 4 weeks followed by Hybrid FES cycling which is functional electrical stimulation cycling with the legs and voluntary cycling with the arms for 20-30 minutes twice weekly for 8 weeks.

Active range of motion exercise with the arms 4x10 reps and passive range of motion to legs 4x10.; Muscle strengthening exercise and hybrid FES cycling

Active ROM exercise with arms and Passive ROM exercise with legs OTHER

Active ROM exercise with arms and Passive ROM exercise with legs both 4 sets of 10 repetitions twice weekly

Active range of motion exercise with the arms 4x10 reps and passive range of motion to legs 4x10.; Muscle strengthening exercise and hybrid FES cycling

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men and women ages 21-70 years
• C4-T12 SCI American Spinal Injury Association Impairment Scale A, B, and C as per International Standards for Neurological Classification of SCI
• ≥1 years post-SCI
• Participants must be able to perform voluntary arm cycling.

You may not qualify if:

• pressure wounds on buttocks or feet
• unhealed bone fractures or history of fragility fractures
• uncontrolled cardiovascular disease
• uncontrolled Type-2 diabetes
• severe osteoporosis (T score below -4)
• uncontrolled autonomic dysreflexia
• orthopedic or other problems that preclude leg and arm cycling.

Sponsors & Collaborators

• William Carey University: lead

Study Sites (1)

William Carey University

Hattiesburg, Mississippi, 39401, United States

RECRUITING

Related Publications (13)

• 13. Dolbow DR, Credeur DP, Simmons KA. Peripheral Vascular Changes after Electrically Induced Interval Cycling In a 34-Year-Old Obese Man with Chronic Paraplegia. Clinical Kinesiology. 2017;71(4):40-43.

  RESULT

• Dolbow DR, Credeur DP. Effects of resistance-guided high intensity interval functional electrical stimulation cycling on an individual with paraplegia: A case report. J Spinal Cord Med. 2018 Mar;41(2):248-252. doi: 10.1080/10790268.2017.1367358. Epub 2017 Sep 4.

  PMID: 28868988 RESULT

• Dolbow DR, Credeur DP, Lemacks JL, Stokic DS, Pattanaik S, Corbin GN, Courtner AS. Electrically induced cycling and nutritional counseling for counteracting obesity after spinal cord injury: A pilot study. J Spinal Cord Med. 2021 Jul;44(4):533-540. doi: 10.1080/10790268.2019.1710939. Epub 2020 Jan 23.

  PMID: 31971487 RESULT

• Gillen JB, Martin BJ, MacInnis MJ, Skelly LE, Tarnopolsky MA, Gibala MJ. Twelve Weeks of Sprint Interval Training Improves Indices of Cardiometabolic Health Similar to Traditional Endurance Training despite a Five-Fold Lower Exercise Volume and Time Commitment. PLoS One. 2016 Apr 26;11(4):e0154075. doi: 10.1371/journal.pone.0154075. eCollection 2016.

  PMID: 27115137 RESULT

• Karstoft K, Winding K, Knudsen SH, Nielsen JS, Thomsen C, Pedersen BK, Solomon TP. The effects of free-living interval-walking training on glycemic control, body composition, and physical fitness in type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2013 Feb;36(2):228-36. doi: 10.2337/dc12-0658. Epub 2012 Sep 21.

  PMID: 23002086 RESULT

• Figoni SF, Dolbow DR, Crawford EC, White ML, Pattanaik S. Does aerobic exercise benefit persons with tetraplegia from spinal cord injury? A systematic review. J Spinal Cord Med. 2021 Sep;44(5):690-703. doi: 10.1080/10790268.2020.1722935. Epub 2020 Feb 11.

  PMID: 32043944 RESULT

• Dolbow DR, Gorgey AS, Ketchum JM, Moore JR, Hackett LA, Gater DR. Exercise adherence during home-based functional electrical stimulation cycling by individuals with spinal cord injury. Am J Phys Med Rehabil. 2012 Nov;91(11):922-30. doi: 10.1097/PHM.0b013e318269d89f.

  PMID: 23085704 RESULT

• Dolbow DR, Farkas GJ, Berg AS, Welsch MA, Gorgey AS, Gater DR. Fat to lean mass ratio in spinal cord injury: Possible interplay of components of body composition that may instigate systemic inflammation and metabolic syndrome. J Spinal Cord Med. 2022 Nov;45(6):833-839. doi: 10.1080/10790268.2022.2111900. Epub 2022 Sep 21.

  PMID: 36129335 RESULT

• Gorgey AS, Dolbow DR, Dolbow JD, Khalil RK, Gater DR. The effects of electrical stimulation on body composition and metabolic profile after spinal cord injury--Part II. J Spinal Cord Med. 2015 Jan;38(1):23-37. doi: 10.1179/2045772314Y.0000000244. Epub 2014 Jul 8.

  PMID: 25001669 RESULT

• Gorgey AS, Dolbow DR, Dolbow JD, Khalil RK, Castillo C, Gater DR. Effects of spinal cord injury on body composition and metabolic profile - part I. J Spinal Cord Med. 2014 Nov;37(6):693-702. doi: 10.1179/2045772314Y.0000000245. Epub 2014 Jul 7.

  PMID: 25001559 RESULT

• Farkas GJ, Gorgey AS, Dolbow DR, Berg AS, Gater DR. Sex dimorphism in the distribution of adipose tissue and its influence on proinflammatory adipokines and cardiometabolic profiles in motor complete spinal cord injury. J Spinal Cord Med. 2019 Jul;42(4):430-436. doi: 10.1080/10790268.2018.1436125. Epub 2018 Feb 21.

  PMID: 29465306 RESULT

• Evans N, Wingo B, Sasso E, Hicks A, Gorgey AS, Harness E. Exercise Recommendations and Considerations for Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2015 Sep;96(9):1749-50. doi: 10.1016/j.apmr.2015.02.005. Epub 2015 Jul 18. No abstract available.

  PMID: 26198424 RESULT

• Gater DR Jr, Farkas GJ, Dolbow DR, Berg A, Gorgey AS. Body Composition and Metabolic Assessment After Motor Complete Spinal Cord Injury: Development of a Clinically Relevant Equation to Estimate Body Fat. Top Spinal Cord Inj Rehabil. 2021;27(1):11-22. doi: 10.46292/sci20-00079.

  PMID: 33814880 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• David R Dolbow, DPT, PhD

  William Caery University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David R Dolbow, DPT, PhD

CONTACT

601-318-6274; ddolbow@wmcarey.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Physical Therapy, Research Professor College of Osteopathic Medicine

Model Details: Planned Experimental Protocols: The hypothesis for our research aim is that combining the PRIME muscle strengthening program and the hybrid HIIT-FES cycling will reduce obesity, enhance cardiometabolic health markers, improve central and peripheral vascular health, and improve physical function in persons with chronic SCI more than the standard of care ROM exercises. This will be tested using a two-group pre- post-test study design.

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 15, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: August 31, 2027 to August 31, 2032
• Access Criteria: Individual participant data will be kept at William Carey University and is available without individual identifiers upon request from the PI.

Locations

US (1)