Clinical trial NCT04211311: Hybrid High-intensity Interval Training for Persons With Spinal Cord Injury. A Feasibility Study
Official title: "Feasibility of High-intensity Interval Training (HIIT) as Hybrid Exercise Using Functional Electrical Stimulation Leg-cycling (FEScycling) and Ski Ergometer (SkiErg) With the Arms for People With Chronic Spinal Cord Injury Paraplegia"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study examines safety and feasibility of a study protocol using a combination of functional electrical legcycling with voluntary armwork (hybrid training) as either skiergometer or armcycling in high intensity intervals for persons with spinal cord injury paraplegia.

Detailed description: Cardiovascular disease is one of the most common causes of early death in people with spinal cord injury. Physical activity at high intensity is known to reduce the risk of cardiovascular disease in other patient groups.

During aerobic training, combining functional electrical stimulation (FES) with voluntary arm-work induces a higher oxygen uptake than FES cycling alone and high intensity interval training induces higher oxygen uptake than training at continuous intensity. The hypothesis is that combining hybrid training with high-intensity induces even higher oxygen uptake thereby reducing the risk of cardiovascular disease. This training modality has not been tested before, so before conducting a randomized controlled trial testing the effect of this training modality on oxygen uptake, the aim was to asses safety and feasibility of this protocol.

Eligibility criteria: Inclusion Criteria:

* spinal cord injury paraplegia,
* complete and incomplete lesions,
* ability to be electrically stimulated,
* willing to train 3 times a week at high intensity

Exclusion Criteria:

* heart pacemaker or other heart problems contradicting high intensity aerobic training,
* pregnancy,
* unstable fractures,
* cancer,
* heterotopic ossification,
* myositis ossificans,
* severe osteoporosis,
* pressure ulcers,
* newly implanted metal,
* newly surgery,
* frequent episodes of autonomic hyperreflexia,
* very high or low blood pressure,
* dislocation or subluxation of joints
* high level of shoulder pain at study start.

Primary outcomes:
measure: Number of serious adverse events
timeFrame: 8 weeks
measure: Shoulder pain
timeFrame: 8 weeks
measure: compliance
timeFrame: 8 weeks
measure: intensity
timeFrame: 8 weeks
Secondary outcomes:
measure: Peak oxygen uptake
timeFrame: 8 weeks
measure: leisure time physical activity
timeFrame: 8 weeks
measure: health related quality of life
timeFrame: 8 weeks
measure: Fatigue
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rødovre
country: Denmark
facility: Specialhospitalet for Polio og Ulykkesramte
Study officials:
affiliation: Denmark, University of Southern Denmark, Odense, Funen, Denmark, 5230
name: Birgit Juul-Kristensen, Assoc Prof
role: STUDY_DIRECTOR
References:
citation: Vestergaard M, Jensen K, Juul-Kristensen B. Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. Pilot Feasibility Stud. 2022 Feb 22;8(1):43. doi: 10.1186/s40814-022-00997-2.