12 Participants NeededMy employer runs this trial

Hybrid HIIT-FES Cycling for Spinal Cord Injury

DR
Overseen ByDavid R Dolbow, DPT, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with spinal cord injuries (SCI) improve their health through a new exercise program. The study focuses on a combination of high-intensity interval training (HIIT) and functional electrical stimulation (FES) cycling, which involves cycling with both legs and arms. This program is called the Hybrid HIIT-FES Cycling Program. The goal is to determine if this exercise approach can improve heart health and muscle function more effectively than standard exercises. People who have had a spinal cord injury for at least a year and can cycle with their arms might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative exercise methods that could enhance the recovery journey.

What prior data suggests that this hybrid HIIT-FES cycling protocol is safe for individuals with spinal cord injury?

Research has shown that the Hybrid HIIT-FES Cycling Program is generally safe for people with spinal cord injuries (SCI). This high-intensity interval training combines arm and leg exercises with electrical stimulation to aid muscle movement. Studies have found that most participants tolerate it well, experiencing no serious side effects.

For instance, one study found that people with SCI who tried hybrid HIIT attended sessions regularly, with very few discontinuing. This suggests they found the exercise both manageable and safe. Another study reported improvements in muscle health and fitness without major negative effects.

Overall, evidence suggests that the Hybrid HIIT-FES Cycling Program is a safe exercise option for individuals with SCI. It may enhance muscle and heart health with minimal risk of side effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Hybrid HIIT-FES Cycling Program for spinal cord injury because it combines high-intensity interval training (HIIT) with functional electrical stimulation (FES) to enhance muscle function, which is not typically seen in standard care. Unlike traditional therapies that often involve only passive or active range of motion exercises, this program actively engages muscles in both voluntary and electronically stimulated cycling, potentially offering better strength and endurance improvements. By integrating these elements, the program aims to maximize rehabilitation outcomes and improve quality of life for individuals with spinal cord injuries.

What evidence suggests that the Hybrid HIIT-FES Cycling Program could be effective for spinal cord injury?

Research has shown that functional electrical stimulation (FES) cycling can enhance muscle health in the lower body for people with spinal cord injuries (SCI). It builds muscle, reduces fat, and improves aerobic fitness. In this trial, one group of participants will engage in a Hybrid HIIT-FES Cycling Program, which combines high-intensity interval training (HIIT) with FES cycling. This combination may improve muscle function and heart health in less time. FES cycling has been linked to increased strength and better blood flow in the legs, suggesting that the Hybrid HIIT-FES Cycling Program might effectively improve health outcomes for individuals with SCI.12367

Who Is on the Research Team?

DR

David R Dolbow, DPT, PhD

Principal Investigator

William Caery University

Are You a Good Fit for This Trial?

This trial is for people with spinal cord injuries. Participants should be able to take part in exercise programs and not have any medical issues that would make exercise unsafe, as determined by the study team.

Inclusion Criteria

At least 1 year post-SCI
I am between 21 and 70 years old.
My spinal cord injury is between C4 and T12 and is classified as ASIA A, B, or C.
See 1 more

Exclusion Criteria

I have severe osteoporosis with a T score below -4.
I have uncontrolled episodes of sudden high blood pressure due to nerve problems.
I have pressure sores on my buttocks or feet.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PRIME Muscle Strengthening

Participants undergo peripheral remodeling intermittent muscular exercise (PRIME) for preliminary muscle strengthening

4 weeks
2 visits per week

Hybrid HIIT-FES Cycling

Participants engage in hybrid high-intensity interval training with functional electrical stimulation cycling

8 weeks
2 visits per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Hybrid HIIT-FES Cycling Program
  • Peripheral Remodeling Intermittent Muscular Exercise (PRIME)

Trial Overview

The study compares a new program combining muscle strengthening, high-intensity interval training (HIIT), and hybrid cycling using both arm movement and electrical stimulation of leg muscles, against standard range of motion exercises for arms and legs.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Muscle strengthening exercise and hybrid FES cyclingExperimental Treatment2 Interventions
Group II: Active range of motion exercise with the arms 4x10 reps and passive range of motion to legs 4x10.Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

William Carey University

Lead Sponsor

Trials
2
Recruited
20+

Citations

Study Details | NCT07648173 | Hybrid HIIT-FES Cycling ...

Low cadence cycling (10 rpm) has been shown to provide greater muscle hypertrophy in the legs than high cadence (50 rpm) cycling, demonstrating ...

Hybrid high-intensity interval training using functional ...

Functional electrical stimulation cycling exercise after spinal cord injury: a systematic review of health and fitness-related outcomes. J ...

Functional electrical stimulation cycling exercise after spinal ...

Current evidence indicates that FES cycling exercise improves lower-body muscle health of adults with SCI, and may increase power output and aerobic fitness.

Functional electrical stimulation cycling exercise after spinal ...

CONCLUSION: Current evidence indicates that FES cycling exercise improves lower-body muscle health of adults with SCI, and may increase power output and aerobic ...

Evaluating the Health and Fitness Benefits of ...

Conclusions: FES-cycling on a recumbent trike shows potential as a therapeutic and recreational activity for individuals with SCI. It ...

Systematic Review of the Exercise or Health-Related ...

The findings from these studies suggest that FES cycling may lead to cardiorespiratory and muscle benefits in adults with acute and chronic SCI. Children with ...

Testosterone + Hybrid Exercise for Spinal Cord Injury

Hybrid HIIT was safe for people with SCI paraplegia. The majority of the criteria for feasibility were met with acceptable attendance rate, limited drop out. 7.