Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia

Официальное название

Effect of Manual Diaphragmatic Release on Exercise Capacity and Quality of Life in Women With Fibromyalgia: A Randomized Controlled Trial

Обзор

Evaluate the effect of manual diaphragmatic release on exercise capacity, inspiratory muscles strength, symptoms severity, and health-related quality of life in women diagnosed with fibromyalgia.

Подробное описание

Sixty women diagnosed with fibromyalgia will be recruited from outpatient rheumatology and physical therapy clinics. Following clinical screening, patients will be randomly assigned into two parallel groups:

The Study Group: Will include 30 women participating in manual diaphragmatic release plus aerobic training for 8 weeks.

The Control Group: Will include 30 women participating in aerobic training only for 8 weeks.

At baseline and post-study (after 8 weeks), outcomes will be comprehensively assessed. The primary focus is to determine whether manual release of the diaphragm improves exercise capacity, minimizes the overall impact of fibromyalgia symptoms, improves health-related quality of life metrics, and enhances respiratory muscles strength.

Вмешательства

• Другое Manual Diaphragmatic Release
  Thrice a week for 8 weeks, the participant will assume a supine position with relaxed limbs. The therapist will position themselves at the head of the participant and make manual contact with the pisiform, hypothenar region, and the last three fingers on both sides, underneath the seventh to tenth rib costal cartilages. During the inspiratory phase, the therapist gently pulls the contact points toward the head and slightly laterally, progressively deepening contact within the costal margin over
• Другое Aerobic Training
  3 sessions per week consisting of 30-45 minutes of cycling at low-to-moderate intensity on a cycle ergometer. Intensity will be managed at a workout heart rate ranging between 60% to 70% of the maximal heart rate, accompanied by a brief warm-up and cool-down phase.

Первичные конечные точки

• Exercise Capacity [Срок оценки: Baseline and after 8 weeks]

Вторичные конечные точки (3)

• Health-Related Quality of Life [Срок оценки: Baseline and after 8 weeks]
• Fibromyalgia Symptom Severity [Срок оценки: Baseline and after 8 weeks]
• Respiratory Muscle Strength [Срок оценки: Baseline and after 8 weeks]

Критерии участия

Критерии включения

• Confirmed clinical diagnosis of fibromyalgia fulfilling the American College of Rheumatology diagnostic criteria.
• Sedentary or low physical activity status (not participating in structured exercise programs within the past 3 months).

Критерии исключения

• Severe psychiatric comorbidities (e.g., major depressive disorder with active suicidal ideation) or cognitive impairments.
• Presence of comorbid rheumatologic or autoimmune conditions that overlap with muscle/joint symptoms (e.g., severe rheumatoid arthritis, systemic lupus erythematosus).
• Primary chronic respiratory/chest diseases (e.g., severe COPD or active asthma).
• Cardiovascular disorders or uncontrolled hypertension.
• Pregnancy.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07641166 · Diaphragmatic Release

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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