Cardiorespiratory Fitness Training in Patients with Incomplete Spinal Cord Injury
- Conditions
- Incomplete Spinal Cord InjuryExercise Training
- Interventions
- Other: Cardiorespiratory fitness (CRF) training
- Registration Number
- NCT06259227
- Lead Sponsor
- Sint Maartenskliniek
- 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.
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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
- Unable to give informed consent
- Language barrier
- Participating in another interventional study targeting cardiorespiratory fitness
- Have contraindications to perform exercise during the rehabilitation program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Cardiorespiratory fitness (CRF) training During the primary rehabilitation program, the intervention group will receive 2-3 individualized cardiorespiratory fitness training sessions per week.
- Primary Outcome Measures
Name Time Method Change in cardiorespiratory fitness 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
- Secondary Outcome Measures
Name Time Method 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) 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).
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) 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.
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) Daily life gait performance is measured by inertial measurements units (IMU), determining spatiotemporal parameters. Furthermore, the Activ8 activity monitor will be used.
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) 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.
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) Measured by simple spirometry and defined as the volume expired in the first second of the FVC maneuver in liters.
Pulmonary function - Peak Expiratory Flow (PEF) 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) Measured by simple spirometry and defined as the maximal expiratory flow rate achieved during the FVC maneuver and is defined in liters/minute.
Neurological status 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) 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).
Cardiometabolic risk factors - Waist circumference (cm) Baseline (T0) , 3 months after end of outpatient rehab (T6) Measured in a standing position across the belly button during the exhale.
Cardiometabolic risk factors - Skinfold thickness Baseline (T0) , 3 months after end of outpatient rehab (T6) Measured by a skinfold calliper and will be performed according to the American College of Sports Medicine standard description of skinfold measurements.
Muscle force - Grip force 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) 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.
Muscle force - Voluntary muscle strength 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) 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).
Cardiometabolic risk factors - Blood pressure 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) Descriptive outcome measure in mmHg
Cardiometabolic risk factors - Heart rate 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) Descriptive outcome measure in beats per minute
Cardiometabolic risk factors - Total Cholesterol (TC) Baseline (T0) , 3 months after end of outpatient rehab (T6) Measured by a venous blood sample when participants have been sober for 4 hours
Secondary complications - Shoulder pain Baseline (T0), 6 weeks after T0 (T1) 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.
Secondary complications - Number of respiratory and cardiovascular complications 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) Descriptive outcome measure
Secondary complications - Number of rehospitalizations 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) Descriptive outcome measure
Cardiometabolic risk factors - Low Density Lipoprotein Cholesterol (LDL-C) Baseline (T0) , 3 months after end of outpatient rehab (T6) Measured by a venous blood sample when participants have been sober for 4 hours
Cardiometabolic risk factors - High Density Lipoprotein Cholesterol (HDL-C) Baseline (T0) , 3 months after end of outpatient rehab (T6) Measured by a venous blood sample when participants have been sober for 4 hours
Secondary complications - Urinary and bowel dysfunction 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) Descriptive outcome measure
Cardiometabolic risk factors - Fasted insulin Baseline (T0) , 3 months after end of outpatient rehab (T6) Measured by a venous blood sample when participants have been sober for 4 hours
Cardiometabolic risk factors - Fasted glucose Baseline (T0) , 3 months after end of outpatient rehab (T6) Measured by a venous blood sample when participants have been sober for 4 hours
Secondary complications - Level of fatigue experienced during the last week 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) Measured by the visual analog scale (VAS). The VAS is an unidimensional measure, containing a straight horizontal line of 100 mm.
Secondary complications - Pressure sores 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) Descriptive outcome measure including location, severity and duration
Secondary complications - Spasticity 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) 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.
Secondary complications - Level of pain experienced during the last week 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) 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).
Exercise self-efficacy 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) 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.
Quality of Life (QoL) 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) 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.
Functional independence 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) 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.
Trial Locations
- Locations (1)
Sint Maartenskliniek
🇳🇱Ubbergen, Netherlands