Respiratory Biofeedback Added to Strengthening Training in Patients With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diaphragmatic biofeedback combined with respiratory muscle training, PLACEBO INTERVENTION.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease (Stages 4 and 5). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Other 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 - Other 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.
Primary outcome measures
- Number of participants with treatment-related adverse events during intervention sessions [Time frame: Baseline to 6 weeks]
- Respiratory Symptoms assessed by Edmonton Symptom Assessment Scale (ESAS) [Time frame: Baseline to 6 weeks]
- Respiratory Complications [Time frame: Baseline to 12 weeks]
- Quality of Life of participants evaluated by Euqol-5Dimensions questionnaire [Time frame: Baseline to 6 weeks]
- Acceptability of intervention considering number of sessions completed by participant [Time frame: 6 weeks]
Secondary outcome measures (1)
- Cardiorespiratory Capacity evaluated using 6 Minutes Walking test [Time frame: Baseline to 6 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07369973 · SICEIA-2024-003384