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Hybrid High-intensity Interval Training for Persons With Spinal Cord Injury. A Feasibility Study

NCT ID: NCT04211311

Last Updated: 2019-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-30

Study Completion Date

2018-06-01

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FES-legcycling with voluntary arm-work

FES-legcycling combined with arm ski-ergometer or arm-cycling

Group Type EXPERIMENTAL

hybrid high-intensity training

Intervention Type OTHER

FES-legcycling combined with either arm skiergometer or arm-cycling in 4 x 4 min. intervals at 90% peak power output, 3 times a week for 8 weeks

Interventions

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hybrid high-intensity training

FES-legcycling combined with either arm skiergometer or arm-cycling in 4 x 4 min. intervals at 90% peak power output, 3 times a week for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Birgit Juul-Kristensen, Assoc Prof

Role: STUDY_DIRECTOR

Denmark, University of Southern Denmark, Odense, Funen, Denmark, 5230

Locations

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Specialhospitalet for Polio og Ulykkesramte

Rødovre Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 35193705 (View on PubMed)

Other Identifiers

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d4qxwjy6

Identifier Type: -

Identifier Source: org_study_id