Incomplete Spinal Cord InjuryFIT@HOMENCT06259227
Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury
A study testing Cardiorespiratory fitness (CRF) training in people with Incomplete Spinal Cord Injury and Exercise Training, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incomplete Spinal Cord Injury, Exercise Training
- What is being tested?
- Cardiorespiratory fitness (CRF) training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Jan 2024to 19 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to give informed consent
- Language barrier
- Participating in another interventional study targeting cardiorespiratory fitness
- Have contraindications to perform exercise during the rehabilitation program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury During Primary Rehabilitation
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.
Read the detailed description
Rationale:
Despite advances in medical care, spinal cord injury (SCI) patients have significantly lower survival rates compared to the general population. The 'Koepelproject', an unique world-leading multi-center research project, discovered that SCI patients have a decreased pulmonary function, which is linked to poor cardiorespiratory fitness (CRF). This leads to respiratory and cardiovascular diseases, which are important predictors of death in SCI patients. However, there are limitations of the 'Koepelproject' which highlight the need for the proposed project 'FIT@HOME'. Rehabilitation knowledge in SCI patients is primarily focused on those with a complete lesion, while there has been changes in the characteristics of the SCI population over the last few decades. The diagnosis of an incomplete SCI (iSCI) is more common and requires different insights and skills compared to patients with complete lesions. Therefore, insight in the effect of personalized rehabilitation strategies focussed on CRF during primary rehabilitation will provide important information to support healthy ageing in iSCI patients.
Objective:
The primary aim of this study is to assess the effect of a personalized training intervention on CRF during primary rehabilitation and at follow-up. Secondary aims of this study are to determine the effect of this training intervention on gait capacity, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, quality of life (QoL), functional independence and exercise self-efficacy.
Study design:
The proposed study design is an explorative randomized controlled trial.
Study population:
This study will include 32 iSCI patients classified with an American Spinal Injury Association (ASIA) C or D in the subacute phase (< 6 months post injury), who are referred for a primary, inpatient rehabilitation program at the Sint Maartenskliniek.
Intervention:
The intervention includes 2-3 personalized CRF-focused training sessions per week. The control group receives usual care.
Main study parameters/endpoints:
The primary endpoint is the change in CRF (expressed as VO2peak) after the 6-weeks intervention period and at follow-up.
Secondary outcomes are gait assessments, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, secondary complications, quality of life, functional independence and exercise self-efficacy.
Measurements will be performed at:
T0 - Baseline
T1 - Following the 6-weeks intervention period during the primary rehabilitation program at the Sint Maartenskliniek
T2* - At discharge from the primary rehabilitation program at the Sint Maartenskliniek (only if the period following T1 is more than 2 weeks)
T3 - After 2 weeks in the outpatient rehabilitation program at the Sint Maartenskliniek
T4 - At discharge from the outpatient rehabilitation program at the Sint Maartenskliniek
T5 - 2 weeks following discharge from the outpatient rehabilitation program at the Sint Maartenskliniek (2 weeks after T4)
T6 - 3 months following discharge from the outpatient rehabilitation program at the Sint Maartenskliniek (3 months after T4, 2.5 months after T5)
- Conditions
- Incomplete Spinal Cord Injury, Exercise Training
- Being tested
- Cardiorespiratory fitness (CRF) training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiorespiratory fitness (CRF) trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | During the primary rehabilitation program, the intervention group will receive 2-3 individualized cardiorespiratory fitness training sessions per week. Receives: Other: Cardiorespiratory fitness (CRF) training |
| Control group | No intervention | The control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness
Defined as VO2peak in ml/kg/min
Measured: 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
Measured by Walking Index of Spinal Cord Injury (WISCI II), which is an ordinal scale (0-20) consisting of 21 items reflecting various levels of walking ability, taking into account the use of assistive devices, orthotic devices and physical assistance.
Measured: 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
Measured by the self-paced 2-Minute-Walk-Test (2MWT). Participants will be instructed to walk as far as possible at a comfortable walking speed in two minutes. The total distance walked in meters will be recorded. Furthermore, participants will be fitted with a facemask that will allow for the collection of respiratory gasses. Oxygen uptake and heart rate will be measured during the 2MWT (walking efficiency).
Measured: 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
Daily life gait performance is measured by inertial measurements units (IMU), determining spatiotemporal parameters. Furthermore, the Activ8 activity monitor will be used.
Measured: 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)
Measured by simple spirometry and defined as the total volume of air that a person can forcibly exhale during a maximal expiratory effort in liters.
Measured: 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)
Measured by simple spirometry and defined as the volume expired in the first second of the FVC maneuver in liters.
Measured: 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 - Peak Expiratory Flow (PEF)
Measured by simple spirometry and defined as the maximal expiratory flow rate achieved during the FVC maneuver and is defined in liters/minute.
Measured: 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)
Neurological status
Measured by the ASIA impairment scale will be used for both a motor and sensory examination. The ASIA impairment scale consists of a 5-point ordinal scale, which classifies individuals from "A" (complete SCI) to "E" (normal sensory and motor function).
Measured: 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)
Muscle force - Grip force
Measured by handgrip strength of the dominant hand. This will be assessed with a hydraulic, analogue hand dynamometer adjusted to the hand size of every participant.
Measured: 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)
Muscle force - Voluntary muscle strength
Voluntary muscle strength of 5 key muscles of both lower extremities and key muscles of both upper extremities in accordance with standard neurological assessment (ASIA). A six-point scale is used for scoring with 0 being total paralysis and 5 is normal active moment, full range of motion against gravity and expected from an unimpaired person.Upper extremity muscle strength will also be measured using a handheld dynamometer (HHD).
Measured: 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)
Cardiometabolic risk factors - Waist circumference (cm)
Measured in a standing position across the belly button during the exhale.
Measured: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Skinfold thickness
Measured by a skinfold calliper and will be performed according to the American College of Sports Medicine standard description of skinfold measurements.
Measured: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Blood pressure
Descriptive outcome measure in mmHg
Measured: 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)
Cardiometabolic risk factors - Heart rate
Descriptive outcome measure in beats per minute
Measured: 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)
Cardiometabolic risk factors - Low Density Lipoprotein Cholesterol (LDL-C)
Measured by a venous blood sample when participants have been sober for 4 hours
Measured: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - High Density Lipoprotein Cholesterol (HDL-C)
Measured by a venous blood sample when participants have been sober for 4 hours
Measured: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Total Cholesterol (TC)
Measured by a venous blood sample when participants have been sober for 4 hours
Measured: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Fasted insulin
Measured by a venous blood sample when participants have been sober for 4 hours
Measured: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Fasted glucose
Measured by a venous blood sample when participants have been sober for 4 hours
Measured: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Secondary complications - Urinary and bowel dysfunction
Descriptive outcome measure
Measured: 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 complications - Level of pain experienced during the last week
Measured by the visual analog scale (VAS). The VAS is an unidimensional measure, containing a straight horizontal line of 100 mm. Furthermore, pain will be classified according to the type of pain (neuropathic or nociceptive (musculoskeletal / visceral / other).
Measured: 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 complications - Shoulder pain
Measured by the pain subscale of the Shoulder Pain and Disability Index (SPADI) questionnaire. The subscale consists of five items on the numerical rating scale from 0 to 10, with a higher value indicating more disability.
Measured: Baseline (T0), 6 weeks after T0 (T1)
Secondary complications - Level of fatigue experienced during the last week
Measured by the visual analog scale (VAS). The VAS is an unidimensional measure, containing a straight horizontal line of 100 mm.
Measured: 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 complications - Pressure sores
Descriptive outcome measure including location, severity and duration
Measured: 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 complications - Spasticity
Measured by the Modified Ashworth Scale (MAS). The MAS is a scale of perceived resistance (tone) against passive movement of the limb and is the most widely used scale in the clinical setting. MAS assigns a grade of spasticity from a 0-4 ordinal scale, where lower scores represent normal muscle tone and higher scores represent spasticity.
Measured: 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 complications - Number of respiratory and cardiovascular complications
Descriptive outcome measure
Measured: 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 complications - Number of rehospitalizations
Descriptive outcome measure
Measured: 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)
Quality of Life (QoL)
Measured by the Quality of Life Basic Data Set Version 2.0 (QoL-BDS V2.0). This questionnaire includes four items on the individual's satisfaction with their life as a whole, their physical health, mental health, and social life. All items use a 0-10 numerical rating scale with higher scores indicating better QoL.
Measured: 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)
Functional independence
Measured by the Spinal Cord Independence Measure III (SCIM III). This questionnaire includes three specific areas of function: selfcare, respiration and sphincter management and a patient's mobility abilities. Each subscale score is evaluated within the 100-point scale, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence.
Measured: 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)
Exercise self-efficacy
Measured by the exercise self-efficacy scale (ESES). The ESES consists of 10 items about level of self-confidence with regard to performing regular physical activities and exercise.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start11 Jan 2024
- Primary completion28 Jul 2025
- Study completion19 Aug 2025
Why it stopped: The study was discontinued due to a departmental reorganization, combined with higher-than-expected screening dropout and insufficient eligible participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Ilse van Nes, Dr., Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259227
- Sponsor's protocol ID
- 1045
- Other IDs
- NL81465.091.22
- Acronym
- FIT@HOME
- Status last verified
- Apr 2026
- First submitted
- 18 Sep 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury During Primary Rehabilitation
- ClinicalTrials.gov ID
- NCT06259227
- Acronym / sponsor ID
- FIT@HOME / 1045
- Conditions
- Incomplete Spinal Cord Injury, Exercise Training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued due to a departmental reorganization, combined with higher-than-expected screening dropout and insufficient eligible participants.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale:
Despite advances in medical care, spinal cord injury (SCI) patients have significantly lower survival rates compared to the general population. The 'Koepelproject', an unique world-leading multi-center research project, discovered that SCI patients have a decreased pulmonary function, which is linked to poor cardiorespiratory fitness (CRF). This leads to respiratory and cardiovascular diseases, which are important predictors of death in SCI patients. However, there are limitations of the 'Koepelproject' which highlight the need for the proposed project 'FIT@HOME'. Rehabilitation knowledge in SCI patients is primarily focused on those with a complete lesion, while there has been changes in the characteristics of the SCI population over the last few decades. The diagnosis of an incomplete SCI (iSCI) is more common and requires different insights and skills compared to patients with complete lesions. Therefore, insight in the effect of personalized rehabilitation strategies focussed on CRF during primary rehabilitation will provide important information to support healthy ageing in iSCI patients.
Objective:
The primary aim of this study is to assess the effect of a personalized training intervention on CRF during primary rehabilitation and at follow-up. Secondary aims of this study are to determine the effect of this training intervention on gait capacity, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, quality of life (QoL), functional independence and exercise self-efficacy.
Study design:
The proposed study design is an explorative randomized controlled trial.
Study population:
This study will include 32 iSCI patients classified with an American Spinal Injury Association (ASIA) C or D in the subacute phase (< 6 months post injury), who are referred for a primary, inpatient rehabilitation program at the Sint Maartenskliniek.
Intervention:
The intervention includes 2-3 personalized CRF-focused training sessions per week. The control group receives usual care.
Main study parameters/endpoints:
The primary endpoint is the change in CRF (expressed as VO2peak) after the 6-weeks intervention period and at follow-up.
Secondary outcomes are gait assessments, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, secondary complications, quality of life, functional independence and exercise self-efficacy.
Measurements will be performed at:
T0 - Baseline
T1 - Following the 6-weeks intervention period during the primary rehabilitation program at the Sint Maartenskliniek
T2* - At discharge from the primary rehabilitation program at the Sint Maartenskliniek (only if the period following T1 is more than 2 weeks)
T3 - After 2 weeks in the outpatient rehabilitation program at the Sint Maartenskliniek
T4 - At discharge from the outpatient rehabilitation program at the Sint Maartenskliniek
T5 - 2 weeks following discharge from the outpatient rehabilitation program at the Sint Maartenskliniek (2 weeks after T4)
T6 - 3 months following discharge from the outpatient rehabilitation program at the Sint Maartenskliniek (3 months after T4, 2.5 months after T5)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Cardiorespiratory fitness (CRF) trainingDuring the primary rehabilitation program, the intervention group will receive 2-3 individualized cardiorespiratory fitness training sessions per week. |
| Control group | No intervention | –The control group will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Unable to give informed consent
- Language barrier
- Participating in another interventional study targeting cardiorespiratory fitness
- Have contraindications to perform exercise during the rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiorespiratory fitness (CRF) trainingThe 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. | Other | Intervention group |
Primary outcome
Change in cardiorespiratory fitness
Time frame: 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)
Defined as VO2peak in ml/kg/min
29 secondary outcomes
Gait assessments - Walking ability
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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 - Peak Expiratory Flow (PEF)
Time frame: 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)
Neurological status
Time frame: 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)
Muscle force - Grip force
Time frame: 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)
Muscle force - Voluntary muscle strength
Time frame: 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)
Cardiometabolic risk factors - Waist circumference (cm)
Time frame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Skinfold thickness
Time frame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Blood pressure
Time frame: 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)
Cardiometabolic risk factors - Heart rate
Time frame: 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)
Cardiometabolic risk factors - Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - High Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Total Cholesterol (TC)
Time frame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Fasted insulin
Time frame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Cardiometabolic risk factors - Fasted glucose
Time frame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
Secondary complications - Urinary and bowel dysfunction
Time frame: 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 complications - Level of pain experienced during the last week
Time frame: 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 complications - Shoulder pain
Time frame: Baseline (T0), 6 weeks after T0 (T1)
Secondary complications - Level of fatigue experienced during the last week
Time frame: 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 complications - Pressure sores
Time frame: 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 complications - Spasticity
Time frame: 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 complications - Number of respiratory and cardiovascular complications
Time frame: 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 complications - Number of rehospitalizations
Time frame: 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)
Quality of Life (QoL)
Time frame: 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)
Functional independence
Time frame: 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)
Exercise self-efficacy
Time frame: 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)
Results and safety
The study was stopped early (reason given: The study was discontinued due to a departmental reorganization, combined with higher-than-expected screening dropout and insufficient eligible participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilse van Nes, Dr. principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiorespiratory fitness (CRF) training in people with Incomplete Spinal Cord Injury and Exercise Training, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued due to a departmental reorganization, combined with higher-than-expected screening dropout and insufficient eligible participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.