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Набор скоро начнётся NCT07192809

The Effect of Attention Distraction on the Adherence to Exercise, in Chronic Low Back Pain Patients.

Без фазы С лечением Chronic Low Back Pain (CLBP) Distraction Methods Adherence to Care

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: Stabilisation exercise, resistance exercise and distraction task, stabilisation exercise and resistance exercises.
Кому может быть актуально
Состояния в реестре: Chronic Low Back Pain (CLBP), Distraction Methods, Adherence to Care. Базовые параметры: от 18 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
Греция
Следующий шаг
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Официальное название

Chronic Non-Specific Low Back Pain: Investigating the Effectiveness of a Dual-Task Program as an Attention Distraction Strategy

Обзор

This randomized controlled trial aims to investigate whether the use of an attention distraction application during exercise increases patient adherence to exercise programs in chronic non-specific low back pain (CNSLBP). In addition, the study will examine whether higher adherence to exercise leads to improved outcomes in pain levels, functional capacity, kinesiophobia, quality of life, central sensitization, and pain catastrophizing.

Подробное описание

Participants will be stratified based on their level of physical activity according to the International Physical Activity Questionnaire (IPAQ) into:

* Low physical activity * Moderate physical activity * High physical activity

They will then be randomly assigned to one of two groups: (1) an experimental group using the attention distraction application during the standard exercise program and (2) a control group following the same standard exercise program without distraction. The intervention will last for 8 weeks, with participants attending three non-supervised sessions per week (total: 24 training sessions). Each session will last approximately 25-30 minutes. Adherence to the exercise program will be monitored through the EARS questionnaire and the distraction application (The total score ranges from 0 to 24, where a higher score reflects better adherence).

The intervention group sessions consist of 5 minute submaximal warm-up followed by 25 minutes of stabilisation and resistance training with exercises focused on strength and stabilisation while using the distraction application. The training will consist of two parts: warming-up and the resistance and stabilisation program. The resistance program will consist of 4 exercises: knee flexion, abdominal crunches, prone superman and leg extension. Each exercise will be performed for 3 sets of 10 repetitions with a rest of 30 sec corresponding to every set , and 1 minute between each exercise. The stabilisation program will consist of 3 exercises: bridge, plank and side plank. Each exercise will be performed for 3 sets of 1 repetition (maximum time) with a rest of 30 sec corresponding to every set and 1 minute between each exercise. Four levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by increasing the resistance band tension, by changing the base of support or my modifying the length of resistance level arm.

In the control group they will perform the same exercises without the distraction-based application.

The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a CR10scale. The progression will be in line with guidelines provided by the American College of Sports Medicine.

Adherence to the program for both groups will be assessed by the Exercise Adherence Rating Scale (EARS - GR).

Вмешательства

  • Другое Stabilisation exercise, resistance exercise and distraction task
    The 8-week exercise intervention consists of 25 minutes non supervised training while distracting their attention with a knowledge based application
  • Другое stabilisation exercise and resistance exercises
    The 8-week exercise intervention consists of 25 minutes non supervised training without distracting their attention with a knowledge based application

Первичные конечные точки

  • Adherence to exercise [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Adherence to exercise [Срок оценки: During the 6 month intervention period.]
  • Adherence to exercise [Срок оценки: During the 6 month intervention period.]
  • Adherence to exercise [Срок оценки: During the 6 month intervention period]
  • Adherence to exercise [Срок оценки: During the 6 month intervention period]
  • Adherence to exercise [Срок оценки: During the 6 month intervention period]
Вторичные конечные точки (12)
  • Pain Intensity [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Anxiety, Stress, and Depression [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Functionality [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Pain Catastrophizing [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Central Sensitization [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Kinesiophobia [Срок оценки: Baseline, Week 8, and follow-up (6 months)]
  • Individual's health-related quality of life [Срок оценки: Baseline, Week 8, and follow-up (6 months)]
  • Effect of Physical Activity Level [Срок оценки: Analyzed post-intervention based on IPAQ stratification]
  • Work Productivity [Срок оценки: Baseline, Week 8, and follow-up (6 months)]
  • Lumbar Mobility [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Muscle Endurance [Срок оценки: Baseline, Week 8, and follow-up (6 months).]
  • Gait Analysis [Срок оценки: Baseline, Week 8, and follow-up (6 months).]

Критерии участия

Критерии включения

  • Age > 18 years
  • Chronic non-specific low back pain (≥3 months)
  • No physical therapy or structured exercise program in the last 3 months
  • Willingness to use the attention distraction application (for the AD-APP group)
  • Completion of the International Physical Activity Questionnaire (IPAQ)

Критерии исключения

  • History of spinal surgery
  • Neurological conditions affecting movement
  • Regular use of pain relief medication within the past two weeks
  • Pregnancy
  • Severe psychological disorders that may affect compliance

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

Греция · 1 центр
  • University of Thessaly — Lamia

Идентификаторы

NCT: NCT07192809 · 20787/25/TFSKTH - 09/07/2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗