Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207, Switzerland
NCT Number: NCT06905470
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
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Nottwil, Canton of Lucerne, 6207, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20 eccentric resistance training sessions will be performed on a symmetric arm-crank ergometer in a supine position.
The regular strength training intervention consists of a total of 20 training sessions at the gym of the study center, performed following clinical routine procedures.
Time frame: < 1 week pre and 12 weeks post intervention start.
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.
Time frame: < 1 week pre and 12 weeks post intervention start.
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.
Time frame: < 1 week pre and 12 weeks post intervention start.
Change in maximum strength of three handgrip measurements (in kg) of both hands using a Jamar Handgrip Dynamometer.
Time frame: < 1 week pre and 12 weeks post intervention start.
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)
Time frame: < 1 week pre and 12 weeks post intervention start.
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.
Time frame: < 1 week pre and 12 weeks post intervention start.
Change in arm circumference of the right and left lower and upper arm (in cm), will be used to estimate muscle volume.
Time frame: < 1 week pre and 12 weeks post intervention start.
Change in functioning during activities of daily living will be assessed by the Spinal Cord Independence Measure (SCIM) as extracted from clinical records. The SCIM total score ranges from 0-100, with higher scores indicating higher levels of functional independence.
Time frame: < 1 week pre and 12 weeks post intervention start.
Change in health-related quality of life will be assessed using the Short Form Health Survey (SF-12). Weighted physical and mental component scores range from 0-100, with higher scores indicating better physical or mental health.
Time frame: Throughout the intervention phase, week 0-12
Successful implementation of the KREHA training in the clinical routine, by assessing whether the 20 KREHA sessions are completed within 12 weeks.
Time frame: Throughout the intervention phase, week 0-12
Feasibility of the KREHA training progression, by assessing how many training sessions needed to be adapted.
Time frame: Throughout the intervention phase, week 0-12
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.
Contact information is provided by the study sponsor or research team.
Anneke Hertig-Godeschalk, PhD
CONTACT
Fabian Ammann, MSc
CONTACT
Swiss Paraplegic Research, Nottwil
Network
The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation - a Matched-Pair Randomized Controlled Trial
Acronym: KREHA3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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