Меню
Идёт набор NCT06015451

Exercise in Postconcussion Symptoms and Posttraumatic Headache

Без фазы С лечением Brain Concussion Post-Concussion Syndrome Post-Traumatic Headache Craniocerebral Trauma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Sub-symptom threshold exercise.
Кому может быть актуально
Состояния в реестре: Brain Concussion, Post-Concussion Syndrome, Post-Traumatic Headache, Craniocerebral Trauma. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Exercise Interventions in Patients With Postconcussion Symptoms and Posttraumatic Headache. A Randomized Controlled Trial.

Обзор

The goal of this clinical trial is to compare two models of delivery of guided exercise in patients with exercise intolerance after mild head injury. The main question it aims to answer is: • Is a program that includes elements of in-house exercise and follow-up sessions, and repeated treadmill testing, superior to a program with telephone-based follow-up only? Participants will undergo a treadmill test to determine eligibility for the study, and to determine at what intensity level their symptoms worsen (symptom threshold). Thereafter they will exercise 15-20 minutes, 3-5 times per week at 80-90% of the heart rate that was found to be the symptom threshold. One group will receive face-to-face folllow-up and repeated testing, one group will receive telephone-based follow-up only . Researchers will compare these two groups to see if closer follow-up is superior when it comes to recovery from exercise intolerance after 12 weeks of exercise.

Подробное описание

Patients with self-reported symptom exacerbation in relation to physical activity will be screened for inclusion with Buffalo Concussion Treadmill test (BCTT), an incremental treadmill exercise test according to a standard Balke protocol, to the first sign of symptom exacerbation or submaximal exertion. Heart rate and perceived exertion (Borg scale) are measured every minute. Patients who demonstrate symptom exacerbation according to predefined criteria will receive an individually tailored program for workouts with self-selected aerobic activites, of 15-20 minutes duration, 4-5 times per week at 85-90% (measured with HR monitor) of the HR at test termination, and they are randomised to either:

A. Every week the first three weeks, participants will exercise one individual session at the hospital, and the BCTT will be performed every 3rd week at the hospital to be able to shape the intervention.

B. The participants will only exercise at home, and will be contacted by telephone/video call, every week during the first three weeks, thereafter less often, up to every third week.

After 12 weeks, there will be a repeated BCTT, performed by a blinded assessor.

Patient reported outcomes are collected using electronic questionnaires before and after the intervention and 6 months after inclusion.

Вмешательства

  • Другое Sub-symptom threshold exercise
    Aerob exercise at an intensity just below the intensity that provokes symptom exacerbation.

Первичные конечные точки

  • Exercise tolerance [Срок оценки: 3 months]
Вторичные конечные точки (9)
  • Headache burden [Срок оценки: 6 months]
  • Change on self-selected area of function. [Срок оценки: 6 months]
  • Self-reported amount of physical activity [Срок оценки: 6 months]
  • Quality of life after head injury (QOL) [Срок оценки: 6 months]
  • Depressive symptoms [Срок оценки: 6 months]
  • Anxiety [Срок оценки: 6 months]
  • Impact of headaches [Срок оценки: 6 months]
  • Fatigue [Срок оценки: 6 months]
  • Adherence to training [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Age 18-65 years
  • Having sustained a minimal head injury or mild traumatic brain injury at least 2 weeks ago.
  • At least one postconcussion symptoms, of at least moderate degree, occurring within the first week after the head injury.
  • Intolerance for physical activity (self-reported and measured; including symptom exacerbation later on the test day).
  • Capable of giving informed consent.

Критерии исключения

  • More than 2 years since last injury.
  • The symptoms are better explained by other conditions.
  • Severe communication problems, typically due to poor knowledge of Norwegian.
  • Severe psychiatric, neurological, somatic, or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.
  • Safety concerns according to the study medical checklist.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • St. Olavs Hospital, Clinic of Rehabilitation — Trondheim

Идентификаторы

NCT: NCT06015451 · 468196

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗