Respiratory Biofeedback Added to Strengthening Training in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Number of participants with treatment-related adverse events during intervention sessions
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Arm
Placebo intervention based on conscious breathing three times per day for 6 weeks
干预措施: PLACEBO INTERVENTION (Other)
Treatment Arm
Participants will receive diaphragmatic biofeedback combined with respiratory muscle training three times per day for 6 weeks
干预措施: Diaphragmatic biofeedback combined with respiratory muscle training (Other)
结局指标
主要结局
Number of participants with treatment-related adverse events during intervention sessions
时间窗: Baseline to 6 weeks
Adverse events and discomfort related to the intervention will also be recorded to evaluate overall number of adverse events registered during intervention period.
Respiratory Symptoms assessed by Edmonton Symptom Assessment Scale (ESAS)
时间窗: Baseline to 6 weeks
Respiratory symptoms will be assessed using the validated symptom questionnaire and clinical reporting, focusing on perceived dyspnea and fatigue , and other respiratory-related complaints during daily activities. The Edmonton Symptom Assessment Scale (ESAS) is a validated instrument that assesses symptom severity, with each symptom rated on a numeric scale ranging from 0 (no symptom) to 10 (worst possible severity). Thus, higher scores indicate a worse outcome and greater symptom burden.
Respiratory Complications
时间窗: Baseline to 12 weeks
The occurrence of respiratory complications during the intervention period will be monitored and recorded, including any clinically relevant respiratory events reported by participants or identified during follow-up assessments.
Quality of Life of participants evaluated by Euqol-5Dimensions questionnaire
时间窗: Baseline to 6 weeks
Health-related quality of life will be assessed using a validated questionnaire to evaluate perceived physical, emotional, and functional well-being in participants undergoing the intervention. The EuroQol 5-Dimension (EQ-5D) questionnaire is a standardized measure of health-related quality of life comprising five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health states are converted into a utility index score, typically ranging from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health status; additionally, the EQ-5D includes a visual analogue scale (EQ-VAS) from 0 to 100, with higher scores reflecting better perceived health.
Acceptability of intervention considering number of sessions completed by participant
时间窗: 6 weeks
Acceptability of diaphragmatic biofeedback added to respiratory muscle training will be assessed through participant completion rates.
次要结局
- Cardiorespiratory Capacity evaluated using 6 Minutes Walking test(Baseline to 6 weeks)
研究者
Marie Carmen Valenza
Principal Investigator
Universidad de Granada