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Not yet recruiting NCT06905470

The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation

No phase Interventional Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eccentric (KREHA) training, Standard clinical routine strength (STAN) training.
Who it may be relevant to
Registry conditions: Spinal Cord Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation - a Matched-Pair Randomized Controlled Trial

Overview

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

Interventions

  • Procedure Eccentric (KREHA) training
    20 eccentric resistance training sessions will be performed on a symmetric arm-crank ergometer in a supine position.
  • Procedure Standard clinical routine strength (STAN) training
    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.

Primary outcome measures

  • Upper body strength [Time frame: < 1 week pre and 12 weeks post intervention start.]
Secondary outcome measures (7)
  • Upper body strength [Time frame: < 1 week pre and 12 weeks post intervention start.]
  • Handgrip strength [Time frame: < 1 week pre and 12 weeks post intervention start.]
  • Aerobic performance [Time frame: < 1 week pre and 12 weeks post intervention start.]
  • Muscle volume [Time frame: < 1 week pre and 12 weeks post intervention start.]
  • Arm circumference [Time frame: < 1 week pre and 12 weeks post intervention start.]
  • Functioning during activities of daily living [Time frame: < 1 week pre and 12 weeks post intervention start.]
  • Health-related quality of life [Time frame: < 1 week pre and 12 weeks post intervention start.]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Switzerland · 1 center
  • Swiss Paraplegic Centre — Nottwil

Identifiers

NCT: NCT06905470 · 2023-21 · SNCTP000006132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗