Respiratory Biofeedback Added to Strengthening Training in Patients With Chronic Kidney Disease

Обзор

The goal of this clinical trial is to learn whether diaphragmatic biofeedback added to respiratory muscle training improves clinical and functional outcomes in adults with chronic kidney disease. It will also evaluate the feasibility and acceptability of this intervention. The main questions it aims to answer are: Is diaphragmatic biofeedback added to respiratory muscle training acceptable and well tolerated in patients with chronic kidney disease? Does this intervention reduce respiratory symptoms and complications in this population? Does diaphragmatic biofeedback added to respiratory muscle training improve cardiorespiratory capacity and quality of life? Researchers will evaluate diaphragmatic biofeedback combined with respiratory muscle training and a placebo intervention based on conscious breathing to assess its effects. Participants will: * Perform the assigned intervention three times per day for 6 weeks * Follow a structured respiratory muscle training program with diaphragmatic biofeedback * Be monitored for symptoms, respiratory complications, and perceived quality of life throughout the study

Вмешательства

• Другое Diaphragmatic biofeedback combined with respiratory muscle training
  This intervention is novel because it integrates diaphragmatic biofeedback into a structured respiratory muscle training program specifically designed for patients with chronic kidney disease, a population in which respiratory dysfunction is prevalent yet under-addressed. By providing real-time feedback on diaphragmatic activity, the intervention aims to enhance motor learning, improve activation of the diaphragm, and optimize training efficiency beyond conventional breathing or respiratory musc
• Другое PLACEBO INTERVENTION
  The placebo intervention will consist of concious guided breathing sessions based on the participant's subjective respiratory sensations, without the use of objective physiological feedback or diaphragm-specific biofeedback. Participants will be instructed to follow standardized breathing guidance focused on perceived comfort and awareness, matching the intervention group in session frequency and duration.

Первичные конечные точки

• Number of participants with treatment-related adverse events during intervention sessions [Срок оценки: Baseline to 6 weeks]
• Respiratory Symptoms assessed by Edmonton Symptom Assessment Scale (ESAS) [Срок оценки: Baseline to 6 weeks]
• Respiratory Complications [Срок оценки: Baseline to 12 weeks]
• Quality of Life of participants evaluated by Euqol-5Dimensions questionnaire [Срок оценки: Baseline to 6 weeks]
• Acceptability of intervention considering number of sessions completed by participant [Срок оценки: 6 weeks]

Вторичные конечные точки (1)

• Cardiorespiratory Capacity evaluated using 6 Minutes Walking test [Срок оценки: Baseline to 6 weeks]

Критерии участия

Критерии включения

• Adults aged ≥18 years
• Diagnosis of chronic kidney disease (CKD) at any stage
• Clinically stable condition, with no acute medical events in the previous 4 weeks
• Ability to understand and follow breathing and training instructions
• Willingness to participate and provide written informed consent

Критерии исключения

• Acute respiratory infection or unstable pulmonary disease
• Severe cognitive impairment or neurological condition limiting cooperation
• Unstable cardiovascular disease or contraindications to respiratory muscle training
• Recent thoracic or abdominal surgery (<3 months)
• Significant visual impairment that prevents proper use of the biofeedback device
• Participation in another interventional clinical trial during the study period

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07369973 · SICEIA-2024-003384

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗