Personalized Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury During Primary Rehabilitation

Brief Summary

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)

Primary Outcomes

Secondary Outcomes

• 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 - 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 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))
• 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))
• 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))
• Cardiometabolic risk factors - Waist circumference (cm)(Baseline (T0) , 3 months after end of outpatient rehab (T6))
• Cardiometabolic risk factors - Skinfold thickness(Baseline (T0) , 3 months after end of outpatient rehab (T6))
• 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))
• 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))
• 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))
• 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))
• Cardiometabolic risk factors - Total Cholesterol (TC)(Baseline (T0) , 3 months after end of outpatient rehab (T6))
• Secondary complications - Shoulder pain(Baseline (T0), 6 weeks after T0 (T1))
• 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))
• 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))
• Cardiometabolic risk factors - Low Density Lipoprotein Cholesterol (LDL-C)(Baseline (T0) , 3 months after end of outpatient rehab (T6))
• Cardiometabolic risk factors - High Density Lipoprotein Cholesterol (HDL-C)(Baseline (T0) , 3 months after end of outpatient rehab (T6))
• 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))
• Cardiometabolic risk factors - Fasted insulin(Baseline (T0) , 3 months after end of outpatient rehab (T6))
• Cardiometabolic risk factors - Fasted glucose(Baseline (T0) , 3 months after end of outpatient rehab (T6))
• 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))
• 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))
• 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))
• 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))
• 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))
• 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))
• 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))