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

NCT04211311 | Completed

• 1 other identifier: d4qxwjy6
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Peak oxygen uptake

  8 weeks

• leisure time physical activity

  8 weeks

• health related quality of life

  8 weeks

• Fatigue

  8 weeks

Study Arms (1)

FES-legcycling with voluntary arm-work

EXPERIMENTAL

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

Other: hybrid high-intensity training

Interventions

hybrid high-intensity training 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

FES-legcycling with voluntary arm-work

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Specialhospitalet for Polio og Ulykkesramte

Rødovre Municipality, 2610, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35193705 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Birgit Juul-Kristensen, Assoc Prof

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: December 26, 2019
• Study Start: January 30, 2018
• Primary Completion: April 26, 2018
• Study Completion: June 1, 2018
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)