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Идёт набор NCT06087692

Efficacy of Video-Based Interactive Game Therapy in Interstitial Lung Patients

Без фазы С лечением Interstitial Lung Disease

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: Exercise.
Кому может быть актуально
Состояния в реестре: Interstitial Lung Disease. Базовые параметры: 40 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence.

Подробное описание

Interstitial lung disease (ILD) is a heterogeneous group of diseases consisting of variable amounts of inflammation and fibrosis and a wide variety of acute and chronic pulmonary disorders affecting both the interstitium and lung parenchyma. Many forms of ILD are progressive over time, associated with severely disabling symptoms and poor quality of life, yet medical treatment options are often limited. There are no specific pulmonary rehabilitation guidelines for this patient population, and standard programs are adapted on a patient basis. However, it is seen that the participation and attendance of patients in pulmonary rehabilitation programs is low, and the benefits obtained from the programs are gradually lost after completing the intensive rehabilitation process and breaking contact with the rehabilitation team. For these reasons, the guidelines emphasize the need to implement new strategies that can overcome limitations, and it is stated that there is a need for research and development of new program models that will make evidence-based pulmonary rehabilitation more accessible for patients. The use of gamification elements in order to encourage changes in health behaviors such as physical activity appears as an entertaining option by increasing extrinsic motivation in sedentary individuals or in diseases where physical activity is targeted. The aim of this study is to investigate the effectiveness of Nintendo Wii applied in addition to aerobic exercise in patients with ILD on exercise capacity and peripheral muscle strength, symptoms, activity and participation with objective methods, based on evidence.

Hypotheses:

H0: Video-based game therapy applied in addition to aerobic exercise in patients with ILD has has no effect on exercise capacity, quality of life and physical fitness level.

H1: Video-based game therapy applied in addition to aerobic exercise in patients with ILD increases exercise capacity, quality of life and physical fitness level.

Patients in the Nintendo group will be included a medium intensity (40-60% of the maximum heart rate or 4-6 intensity according to the Modified Borg scale) aerobic exercise program with a horizontal bicycle ergometer 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist, and then they will be included in ''Wii Fit'' exercise program an average of 30 minutes. Patients in the aerobic exercise group will be included a medium intensity (%40-60 of the maximum heart rate or 4-6 intensity according to the Modified Borg Scala) aerobic exercise program with a horizontal bicycle ergometer, 2 days a week for 8 weeks, lasting an average of 30 minutes, accompanied by a physiotherapist. After eight weeks, all assessments will be repeated.

As a result of this study, the contribution of video-based interactive game therapy to exercise capacity, peripheral muscle strength, physical activity level, symptoms, activity and participation levels in patients with ILD will be determined and compared.

Вмешательства

  • Другое Exercise
    -based game therapy applied in addition to aerobic exercise

Первичные конечные точки

  • 6 minute walk test [Срок оценки: through study completion, an average of 1 year]
  • Incremental Shuttle Walk Test [Срок оценки: through study completion, an average of 1 year]
  • Endurance Shuttle Walk Test [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (9)
  • Respiratory Muscle Strength [Срок оценки: through study completion, an average of 1 year]
  • Muscle strength [Срок оценки: through study completion, an average of 1 year]
  • Dyspnea [Срок оценки: through study completion, an average of 1 year]
  • Fatigue [Срок оценки: through study completion, an average of 1 year]
  • The Saint George Respiratory Questionnaire [Срок оценки: through study completion, an average of 1 year]
  • Daily Life Activities: [Срок оценки: through study completion, an average of 1 year]
  • International Physical Activity Questionnaire (Short Form) [Срок оценки: through study completion, an average of 1 year]
  • Leicester Cough Questionnaire [Срок оценки: through study completion, an average of 1 year]
  • Global rating of change (GRC) [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • Diagnosed with ILD (Interstitial lung disease) by a chest diseases specialist, aged between 40-65 years, and have been under follow-up for at least 6 months according to the current ATS/ERS guidelines.
  • Clinically stable, with no exacerbations or infections.
  • Able to walk, with no visual or auditory impairments.
  • Patients with cognitive abilities sufficient to understand commands.

Критерии исключения

Orthopedic and neurological problems that could hinder exercise training.

  • Changes in medical treatment during the study.
  • Unstable cardiac diseases.
  • Insufficient cooperation.
  • Diagnosed visual, auditory, vestibular, or neurological problems that could affect balance.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • İstanbul Faculty of Medicine — Istanbul

Публикации

  • Holland AE, Hill CJ, Conron M, Munro P, McDonald CF. Short term improvement in exercise capacity and symptoms following exercise training in interstitial lung disease. Thorax. 2008 Jun;63(6):549-54. doi: 10.1136/thx.2007.088070. Epub 2008 Feb 1. PMID 18245143
  • Arslan MS, Ozer AY, Bingol Z, Okumus G. Effectiveness of Active Video Games as a Training Tool in Patients With Interstitial Lung Disease: A Randomised Controlled Trial. Respirology. 2026 Mar;31(3):265-275. doi: 10.1002/resp.70166. Epub 2025 Dec 4. PMID 41344887

Идентификаторы

NCT: NCT06087692 · PHD Thesis

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗