Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury — FIT@HOME  

Exercise Training Clinical Trial

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

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Exercise Training
• Incomplete Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT06259227
• Study type: Interventional
• Source: Sint Maartenskliniek
• Contact: Maxime van Oort
• Phone: +31651943045
• Email: m.vanoort@maartenskliniek.nl
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Completion date: February 2026