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

Part of paid clinical trials in Hattiesburg, Mississippi.

Sponsor
William Carey University
Study ID
NCT07648173
Status
Recruiting
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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

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 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

Study Details

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.

Key Dates

Start date
May 29, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Aerobic Fitness [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
William Carey UniversityHattiesburgMississippi39401
David R Dolbow, DPT, PhD
[email protected]
601-318-6274

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