NCT06905470

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

March 5, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

March 5, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

eccentric trainingstrength trainingupper bodyaerobic performancemuscle volume

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Upper body strength

    < 1 week pre and 12 weeks post intervention start.

  • Handgrip strength

    < 1 week pre and 12 weeks post intervention start.

  • Aerobic performance

    < 1 week pre and 12 weeks post intervention start.

  • Muscle volume

    < 1 week pre and 12 weeks post intervention start.

  • Arm circumference

    < 1 week pre and 12 weeks post intervention start.

  • +2 more secondary outcomes

Other Outcomes (3)

  • Feasibility of the KREHA training (total number of training sessions)

    Throughout the intervention phase, week 0-12

  • Feasibility of the KREHA training progression (number of sessions adapted)

    Throughout the intervention phase, week 0-12

  • Feasibility of the KREHA training progression (power adaptation)

    Throughout the intervention phase, week 0-12

Study Arms (2)

Eccentric arm-crank (KREHA) training

EXPERIMENTAL

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

Standard clinical routine strength (STAN) training

ACTIVE COMPARATOR

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

Interventions

20 eccentric resistance training sessions will be performed on a symmetric arm-crank ergometer in a supine position.

Eccentric arm-crank (KREHA) 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.

Standard clinical routine strength (STAN) training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • inflammatory or neurodegenerative diseases (including multiple sclerosis or Guillain-BarrĂ© 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Anneke Hertig-Godeschalk, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Matched-pair randomized controlled trial
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

April 1, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

December 2, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations