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

Официальное название

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

Обзор

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

Вмешательства

• Процедура Eccentric (KREHA) training
  20 eccentric resistance training sessions will be performed on a symmetric arm-crank ergometer in a supine position.
• Процедура 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.

Первичные конечные точки

• Upper body strength [Срок оценки: < 1 week pre and 12 weeks post intervention start.]

Вторичные конечные точки (7)

• Upper body strength [Срок оценки: < 1 week pre and 12 weeks post intervention start.]
• Handgrip strength [Срок оценки: < 1 week pre and 12 weeks post intervention start.]
• Aerobic performance [Срок оценки: < 1 week pre and 12 weeks post intervention start.]
• Muscle volume [Срок оценки: < 1 week pre and 12 weeks post intervention start.]
• Arm circumference [Срок оценки: < 1 week pre and 12 weeks post intervention start.]
• Functioning during activities of daily living [Срок оценки: < 1 week pre and 12 weeks post intervention start.]
• Health-related quality of life [Срок оценки: < 1 week pre and 12 weeks post intervention start.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швейцария · 1 центр

• Swiss Paraplegic Centre — Nottwil

Идентификаторы

NCT: NCT06905470 · 2023-21 · SNCTP000006132

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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