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

Spinal Cord Injuries Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211311
• Other study ID #: d4qxwjy6
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: June 1, 2018

Study information

• Verified date: December 2019
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 1, 2018
• Est. primary completion date: April 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• 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

Locations

Country	Name	City	State
Denmark	Specialhospitalet for Polio og Ulykkesramte	Rødovre

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious adverse events	Assessed by number of incidences of autonomic hyperreflexia or acute cardiac events	8 weeks
Primary	Shoulder pain	Measured using Wheelchair Shoulder Pain Index (WUSPI), a 15 item questionnaire measuring shoulder pain during daily activities. Each item is scored on a 10 mm visual analog scale with anchors no pain to worst pain ever. Total index score range from 0 - 100. Within each item there is a not applicable option. The score used is performance corrected WUSPI score, dividing total index score by number of item responses and multiplied by 15. Higher score indicate higher level of shoulder pain.	8 weeks
Primary	compliance	Assessed with number of dropouts and proportion of fulfilled training minutes	8 weeks
Primary	intensity	Assessed as mean intensity of the 4 x 4 min. intervals as proportion of peak watt measured at baseline test. Peakwatt for FES-cycling was defined as an average of the three highest watt values within 30 sec. For skiergometer peak watt was defined as the highest average of one min. splits.	8 weeks
Secondary	Peak oxygen uptake	Assessed measuring pulmonary gas exchange. Peak oxygen uptake is defined as respiratory exchange ratio of 1.05 or higher, concentration of blood lactate of 7 mmol/l or more and subjective rating of perceived exertion on the Borg 6-20 scale of min. 16.	8 weeks
Secondary	leisure time physical activity	leisure time physical activity measured with leisure time physical activity questionnaire - SCI (LTPAQ-SCI), asking number of min. spent performing low-, moderate and high intensity leisure time physical activity pr. day, scored by multiplying number of min by number of days yielding number of minutes of leisure time physical activity per week.	8 weeks
Secondary	health related quality of life	health related quality of life measured with Short Form 36 (SF-36), categorically based on a three to six categories Likert scale. An algorithm transforms the scores into a 0-100 scoring system, with higher scores indicating better quality of life	8 weeks
Secondary	Fatigue	Assessed with the Multi Dimensional Fatigue Inventory (MFI-20) covering 5 dimensions of fatigue which are scored using a five level scale. Sub scale scores range 4-20 are calculated as the sum of item ratings and total fatigue score range 20-100 is calculated as the sum of sub scale scores with higher scores indicating lower level of fatigue.	8 weeks