The Effects of Eccentric Compared to Standard Strength Training in Primary Spinal Cord Injury Rehabilitation (KREHA3)

July 7, 2026 updated by: Swiss Paraplegic Research, Nottwil

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
    • Canton of Lucerne
      • Nottwil, Canton of Lucerne, Switzerland, 6207
        • Swiss Paraplegic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eccentric arm-crank (KREHA) training
The eccentric training intervention consists of 20 training sessions performed on a symmetric arm-crank (Krafttraining mittels exzentrischer Handkurbel, KREHA) device. The training sessions have a duration of approximately 30 min and will be completed within twelve weeks, with a maximum of three sessions per week.
Procedure: Eccentric (KREHA) training
20 eccentric resistance training sessions will be performed on a symmetric arm-crank ergometer in a supine position.
Active Comparator: Standard clinical routine strength (STAN) training
The standard strength training intervention consists of a total of 20 training sessions at the gym of the study center, performed following clinical routine procedures. The training sessions have a duration of approximately 60 min and will be completed within twelve weeks, with around three sessions per week.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Upper body strength
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.
< 1 week pre and 12 weeks post intervention start.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Upper body strength
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.
< 1 week pre and 12 weeks post intervention start.
Handgrip strength
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.
< 1 week pre and 12 weeks post intervention start.
Aerobic performance
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)
< 1 week pre and 12 weeks post intervention start.
Muscle volume
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.
< 1 week pre and 12 weeks post intervention start.
Arm circumference
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.
< 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.
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.
< 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.
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.
< 1 week pre and 12 weeks post intervention start.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of the KREHA training (total number of training sessions)
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.
Throughout the intervention phase, week 0-12
Feasibility of the KREHA training progression (number of sessions adapted)
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.
Throughout the intervention phase, week 0-12
Feasibility of the KREHA training progression (power adaptation)
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.
Throughout the intervention phase, week 0-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Paraplegic Research, Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-21
  • SNCTP000006132 (Other Identifier: Swiss National Clinical Trials Portal)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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