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

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: Not yet recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Procedure: Eccentric (KREHA) training; Procedure: Standard clinical routine strength (STAN) training

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fabian Ammann, MSc; Phone Number: +41419396624; Email: fabian.ammann@paraplegie.ch
• Study Contact Backup: Name: Anneke Hertig-Godeschalk, PhD; Phone Number: +414 9396603; Email: anneke.hertig@paraplegie.ch

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	< 1 week pre and 12 weeks post intervention start.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	< 1 week pre and 12 weeks post intervention start.
Handgrip strength	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
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.	Throughout the intervention phase, week 0-12
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.	Throughout the intervention phase, week 0-12
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.	Throughout the intervention phase, week 0-12

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: strength training; eccentric training; upper body; aerobic performance; muscle volume
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID 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