Recruiting

PRIME + HIIT-FES Cycling

Sponsor:

William Carey University

Code:

NCT07648173

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Muscle strengthening exercise followed by Hybrid FES cycling Exercise

Active ROM exercise with arms and Passive ROM exercise with legs

Study Details

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

Study ID

NCT07648173

Start date

Mar 3, 2026

Status verified date

Jun, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Muscle strengthening exercise and hybrid FES cycling

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.

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

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.

Interventions

Muscle strengthening exercise followed by Hybrid FES cycling Exercise

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 ROM exercise with arms and Passive ROM exercise with legs

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

Primary outcome measure

  • Aerobic Fitness [ Time Frame: 12 weeks ]
  • Percent body fat [ Time Frame: 12 weeks ]
  • Percent lean mass [ Time Frame: 12 weeks ]
  • Lipid profile [ Time Frame: 12 weeks ]
  • Glucose profile [ Time Frame: 12 weeks ]
  • Inflammation marker [ Time Frame: 12 weeks ]
  • Functional mobility [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

David R Dolbow, DPT, PhD

601-318-6274ddolbow@wmcarey.edu

Locations

William Carey University

Recruiting

Hattiesburg, Mississippi, United States, 39401

Contacts

David R Dolbow, DPT, PhD

601-318-6274ddolbow@wmcarey.edu

More Information

Sponsor

William Carey University

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Hybrid functional electrical stimulation cycling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by William Carey University on 2026-07-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.