Clinical trial NCT06259227: Cardiorespiratory Fitness Training in Patients with Incomplete Spinal Cord Injury
Official title: Personalized Cardiorespiratory Fitness Training in Patients with Incomplete Spinal Cord Injury During Primary Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Exercise Training
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2024-02-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: 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:
measure: Gait assessments - Walking ability
timeFrame: 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)
measure: Gait assessments - Gait capacity
timeFrame: 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)
measure: Gait assessments - Gait performance
timeFrame: 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)
measure: Pulmonary function - Forced Vital Capacity (FVC)
timeFrame: 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)
measure: Pulmonary function - Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 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)
measure: Pulmonary function - Peak Expiratory Flow (PEF)
timeFrame: 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)
measure: Neurological status
timeFrame: 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)
measure: Muscle force - Grip force
timeFrame: 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)
measure: Muscle force - Voluntary muscle strength
timeFrame: 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)
measure: Cardiometabolic risk factors - Waist circumference (cm)
timeFrame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
measure: Cardiometabolic risk factors - Skinfold thickness
timeFrame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
measure: Cardiometabolic risk factors - Blood pressure
timeFrame: 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)
measure: Cardiometabolic risk factors - Heart rate
timeFrame: 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)
measure: Cardiometabolic risk factors - Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
measure: Cardiometabolic risk factors - High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
measure: Cardiometabolic risk factors - Total Cholesterol (TC)
timeFrame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
measure: Cardiometabolic risk factors - Fasted insulin
timeFrame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
measure: Cardiometabolic risk factors - Fasted glucose
timeFrame: Baseline (T0) , 3 months after end of outpatient rehab (T6)
measure: Secondary complications - Urinary and bowel dysfunction
timeFrame: 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)
measure: Secondary complications - Level of pain experienced during the last week
timeFrame: 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)
measure: Secondary complications - Shoulder pain
timeFrame: Baseline (T0), 6 weeks after T0 (T1)
measure: Secondary complications - Level of fatigue experienced during the last week
timeFrame: 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)
measure: Secondary complications - Pressure sores
timeFrame: 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)
measure: Secondary complications - Spasticity
timeFrame: 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)
measure: Secondary complications - Number of respiratory and cardiovascular complications
timeFrame: 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)
measure: Secondary complications - Number of rehospitalizations
timeFrame: 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)
measure: Quality of Life (QoL)
timeFrame: 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)
measure: Functional independence
timeFrame: 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)
measure: Exercise self-efficacy
timeFrame: 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)
Other outcomes:
measure: Age (years)
timeFrame: Baseline (T0)
measure: Sex (male / female)
timeFrame: Baseline (T0)
measure: Height (cm)
timeFrame: Baseline (T0)
measure: Weight (kg)
timeFrame: Baseline (T0)
measure: Body Mass Index (kg/m^2)
timeFrame: Baseline (T0)
measure: Nationality
timeFrame: Baseline (T0)
measure: Medical history
timeFrame: Baseline (T0)
measure: Time since spinal cord injury (days)
timeFrame: Baseline (T0)
measure: Cause of spinal cord injury (traumatic / non-traumatic)
timeFrame: Baseline (T0)
measure: Level of spinal cord injury
timeFrame: Baseline (T0)
measure: Medication use
timeFrame: 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)
measure: Smoking history
timeFrame: Baseline (T0)
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Ilse van Nes, Dr.
role: PRINCIPAL_INVESTIGATOR
References: