Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury

NCT06259227 | Terminated DMC

• 2 other identifiers: 1045NL81465.091.22
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in cardiorespiratory fitness

  Defined as VO2peak in ml/kg/min

  Baseline (T0), 6 weeks after T0 (T1), end of inpatient rehab (T2)* (average 3 months after T0), end of outpatient rehab (T4) (average 3 months after T2) , 3 months after end of outpatient rehab (T6)

Secondary Outcomes (29)

• Gait assessments - Walking ability

  Baseline (T0), 6 weeks after T0 (T1), end of inpatient rehab (T2)* (average 3 months after T0), 2 weeks after T2 (T3), end of outpatient rehab (T4) (average 3 months after T2) , 2 weeks after T4 (T5), 3 months after end of outpatient rehab (T6)

• Gait assessments - Gait capacity

  Baseline (T0), 6 weeks after T0 (T1), end of inpatient rehab (T2)* (average 3 months after T0), 2 weeks after T2 (T3), end of outpatient rehab (T4) (average 3 months after T2) , 2 weeks after T4 (T5), 3 months after end of outpatient rehab (T6)

• Gait assessments - Gait performance

  Baseline (T0), 6 weeks after T0 (T1), end of inpatient rehab (T2)* (average 3 months after T0), 2 weeks after T2 (T3), end of outpatient rehab (T4) (average 3 months after T2) , 2 weeks after T4 (T5), 3 months after end of outpatient rehab (T6)

• Pulmonary function - Forced Vital Capacity (FVC)

  Baseline (T0), 6 weeks after T0 (T1), end of inpatient rehab (T2)* (average 3 months after T0), end of outpatient rehab (T4) (average 3 months after T2) , 3 months after end of outpatient rehab (T6)

• Pulmonary function - Forced Expiratory Volume in 1 second (FEV1)

  Baseline (T0), 6 weeks after T0 (T1), end of inpatient rehab (T2)* (average 3 months after T0), end of outpatient rehab (T4) (average 3 months after T2) , 3 months after end of outpatient rehab (T6)

Other Outcomes (12)

• Age (years)

  Baseline (T0)

• Sex (male / female)

  Baseline (T0)

• Height (cm)

  Baseline (T0)

Study Arms (2)

Intervention group

EXPERIMENTAL

During the primary rehabilitation program, the intervention group will receive 2-3 individualized cardiorespiratory fitness training sessions per week.

Other: Cardiorespiratory fitness (CRF) training

Control group

NO INTERVENTION

The control group will receive usual care.

Interventions

Cardiorespiratory fitness (CRF) training OTHER

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.

Intervention group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of incomplete spinal cord injury based on a stable cause (e.g. traumatic)
• Spinal cord injury classification C or D on the American Spinal Injury Association (ASIA) impairment scale
• During this study in the subacute phase (\< 6 months post injury)
• Hospitalized in the Sint Maartenskliniek for a primary, inpatient rehabilitation program
• Older than 18 years of age
• Able to understand and perform study related procedures
• Capable to sit at least 3 times a day for 2 hours (prerequisites to start the active rehabilitation program)
• The ability to use an arm ergometer

You may not qualify if:

• Unable to give informed consent
• Language barrier
• Participating in another interventional study targeting cardiorespiratory fitness
• Have contraindications to perform exercise during the rehabilitation program

Sponsors & Collaborators

• Sint Maartenskliniek: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Sint Maartenskliniek

Ubbergen, 6574 NA, Netherlands

Location

MeSH Terms

Interventions

Cardiorespiratory Fitness; Corticotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Physical Fitness; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Ilse van Nes, Dr.

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: February 14, 2024
• Study Start: January 11, 2024
• Primary Completion: July 28, 2025
• Study Completion: August 19, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)