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

"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"

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: hybrid high-intensity training

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Rødovre, Denmark, 2610
    • Specialhospitalet for Polio og Ulykkesramte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FES-legcycling with voluntary arm-work; FES-legcycling combined with arm ski-ergometer or arm-cycling	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of serious adverse events	Assessed by number of incidences of autonomic hyperreflexia or acute cardiac events	8 weeks
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
compliance	Assessed with number of dropouts and proportion of fulfilled training minutes	8 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Study Director: Birgit Juul-Kristensen, Assoc Prof, Denmark, University of Southern Denmark, Odense, Funen, Denmark, 5230

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2018
• Primary Completion (ACTUAL): April 26, 2018
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (ACTUAL): December 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: d4qxwjy6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, due to the small sample size (8) as a feasibility study is, and the group is heterogeneous.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No