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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
hybrid high-intensity training
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Specialhospitalet for Polio og Ulykkesramte

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES-legcycling with voluntary arm-work

Arm Description

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

Outcomes

Primary Outcome Measures

Number of serious adverse events
Assessed by number of incidences of autonomic hyperreflexia or acute cardiac events
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.
compliance
Assessed with number of dropouts and proportion of fulfilled training minutes
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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
October 10, 2019
Last Updated
December 20, 2019
Sponsor
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04211311
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
April 26, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES-legcycling with voluntary arm-work
Arm Type
Experimental
Arm Description
FES-legcycling combined with arm ski-ergometer or arm-cycling
Intervention Type
Other
Intervention Name(s)
hybrid high-intensity training
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of serious adverse events
Description
Assessed by number of incidences of autonomic hyperreflexia or acute cardiac events
Time Frame
8 weeks
Title
Shoulder pain
Description
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.
Time Frame
8 weeks
Title
compliance
Description
Assessed with number of dropouts and proportion of fulfilled training minutes
Time Frame
8 weeks
Title
intensity
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Peak oxygen uptake
Description
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.
Time Frame
8 weeks
Title
leisure time physical activity
Description
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.
Time Frame
8 weeks
Title
health related quality of life
Description
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
Time Frame
8 weeks
Title
Fatigue
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Juul-Kristensen, Assoc Prof
Organizational Affiliation
Denmark, University of Southern Denmark, Odense, Funen, Denmark, 5230
Official's Role
Study Director
Facility Information:
Facility Name
Specialhospitalet for Polio og Ulykkesramte
City
Rødovre
ZIP/Postal Code
2610
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No, due to the small sample size (8) as a feasibility study is, and the group is heterogeneous.
Citations:
PubMed Identifier
35193705
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.
Results Reference
derived

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

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