About this trial
The goal of this clinical trial is to assess the effects of eccentric arm-crank (KREHA) training compared to standard clinical routine strength (STAN) training in individuals undergoing primary spinal cord injury (SCI) rehabilitation.
The main questions this trail aims to answer are:
* what are the effects of the training on upper body strength, aerobic performance, muscle volume, functional independence, and health-related quality of life? * is the KREHA training feasible to implement into the rehabilitation routine?
Participants will:
* perform either 20 KREHA sessions or 20 STAN sessions within 12 weeks * perform a test battery to collect data on training effects before (pretest) and after (posttest) the study intervention
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older.
informed consent as confirmed per signature.
traumatic or disease-related SCI.
participating in the routine strength training program during primary SCI rehabilitation at the study center (generally this is initiated around one month after SCI onset).
Disqualifiers
inflammatory or neurodegenerative diseases (including multiple sclerosis or Guillain-Barré syndrome).
comorbidities or other health issues that may interfere with study participation, inability or contraindications to undergo the investigated intervention.
MRI contraindications (magnetic metal parts or electronic implants such as pacemakers in the body).
pregnancy (anamnestic).
Trial design
Parallel
Treatments tested in this trial
Eccentric (KREHA) training
Procedure/Surgery20 eccentric resistance training sessions will be performed on a symmetric arm-crank ergometer in a supine position.
Standard clinical routine strength (STAN) training
Procedure/SurgeryThe regular strength training intervention consists of a total of 20 training sessions at the gym of the study center, performed following clinical routine procedures.
Treatment groups
Trial outcomes
Primary outcomes
Upper body strength
Change in upper body strength will be measured by a one-repetition maximum (1RM) bench press (in kg). The maximum amount of weight that can be pushed upwards for one repetition, while lying in a supine position on a weight training bench.
Secondary outcomes
Upper body strength
Change in upper body strength measured by a 1RM bench pull (in kg). The maximum amount of weight that can be pulled upwards for one repetition, while lying in a prone position on a weight training bench.
Handgrip strength
Change in maximum strength of three handgrip measurements (in kg) of both hands using a Jamar Handgrip Dynamometer.
Aerobic performance
Change in cardiopulmonary adaptations, measured by aerobic performance in an exercise test on a regular arm-crank ergometer. A ramp protocol starting at 20 Watt followed by 1 Watt / 6 sec increments to failure will be used. The following parameters will be evaluated during this aerobic endurance test: power at failure at the end of the test (in Watt), peak oxygen uptake during the test (in ml/kg/min), maximal heart rate (bpm)
Muscle volume
Magnetic resonance imaging (MRI) of relevant upper body muscles of the dominant upper arm and shoulder will be used to measure change in muscle volume.
Other outcomes
Feasibility of the KREHA training (total number of training sessions)
Successful implementation of the KREHA training in the clinical routine, by assessing whether the 20 KREHA sessions are completed within 12 weeks.
Feasibility of the KREHA training progression (number of sessions adapted)
Feasibility of the KREHA training progression, by assessing how many training sessions needed to be adapted.
Feasibility of the KREHA training progression (power adaptation)
Feasibility of the KREHA training progression, by assessing how much the target power (in Watts) of a training session needed to be adapted compared to the initially planned progression.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: