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Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury

NCT06259227 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-04-16

No results posted yet for this study

Summary

The goal of this exploratory randomized controlled trial is to assess the effect of a personalized training intervention during primary rehabilitation of 6 weeks on cardiorespiratory fitness in individuals with subacute (\<6 months) spinal cord injury during primary rehabilitation and during follow-up. Secondary outcomes include the effect on gait assessments, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, quality of life, functional independence and self-efficacy.

Participants in the intervention group will receive 2-3 personalized cardiorespiratory fitness-focused training sessions per week, for a period of 6 weeks. Participants in the control group will receive usual care.

Conditions

  • Incomplete Spinal Cord Injury
  • Exercise Training

Interventions

OTHER

Cardiorespiratory fitness (CRF) training

The CRF training will take place on an arm cycle ergometer, or on an recumbent cross trainer. The duration and intensity of these 2 CRF gait training sessions will be determined by scientific exercise guidelines. A practical way of increasing vigorous-intensity exercise is high-intensity interval training (HIIT). The HIIT intervention consist of 2-3 trainings per week, with each exercise session including a 5-minute warm-up, 30-second interval periods (with a power output up to 90% of the peak power output (PPO)), and 30-second recovery periods. There are 5 minutes of 50% of PPO between interval periods. The number of interval periods increases during the intervention period, resulting in a maximum total training time of 35 minutes.

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Sint Maartenskliniek

    lead OTHER

Principal Investigators

  • Ilse van Nes, Dr. · Sint Maartenskliniek

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2025-07-28
Completion
2025-08-19

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259227 on ClinicalTrials.gov