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

Swiss Paraplegic Research, Nottwil

Status: Not yet enrolling

Conditions: Spinal Cord Injury

Treatments: Procedure: Eccentric (KREHA) training; Procedure: Standard clinical routine strength (STAN) training

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06905470

2023-21

SNCTP000006132 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Eccentric arm-crank (KREHA) training

Experimental group

Description:

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.

Treatment:

Procedure: Eccentric (KREHA) training

Standard clinical routine strength (STAN) training

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard clinical routine strength (STAN) training