Clinical trial NCT06905470: The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation
Official title: The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation - a Matched-Pair Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: eccentric training
strength training
upper body
aerobic performance
muscle volume
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2025-04-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Matched-pair randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: Inclusion Criteria:

* 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).
* wheelchair dependency during activities of daily living, defined by a score of 0-2 in the SCIM subsection regarding "Mobility in the house".
* passed sports medical assessment and having sufficient biceps/triceps function to perform arm-crank training, as determined by an experienced sports medicine physician

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Upper body strength
timeFrame: < 1 week pre and 12 weeks post intervention start.
Secondary outcomes:
measure: Upper body strength
timeFrame: < 1 week pre and 12 weeks post intervention start.
measure: Handgrip strength
timeFrame: < 1 week pre and 12 weeks post intervention start.
measure: Aerobic performance
timeFrame: < 1 week pre and 12 weeks post intervention start.
measure: Muscle volume
timeFrame: < 1 week pre and 12 weeks post intervention start.
measure: Arm circumference
timeFrame: < 1 week pre and 12 weeks post intervention start.
measure: Functioning during activities of daily living
timeFrame: < 1 week pre and 12 weeks post intervention start.
measure: Health-related quality of life
timeFrame: < 1 week pre and 12 weeks post intervention start.
Other outcomes:
measure: Feasibility of the KREHA training (total number of training sessions)
timeFrame: Throughout the intervention phase, week 0-12
measure: Feasibility of the KREHA training progression (number of sessions adapted)
timeFrame: Throughout the intervention phase, week 0-12
measure: Feasibility of the KREHA training progression (power adaptation)
timeFrame: Throughout the intervention phase, week 0-12
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References: