Respiratory Biofeedback Added to Strengthening Training in Patients With Chronic Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidad de Granada
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Diaphragmatic biofeedback combined with respiratory muscle training
Other interventionThis 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 muscle training approaches.
PLACEBO INTERVENTION
Other interventionThe 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events during intervention sessions
Adverse events and discomfort related to the intervention will also be recorded to evaluate overall number of adverse events registered during intervention period.
Time frame
Baseline to 6 weeks2
Respiratory Symptoms assessed by Edmonton Symptom Assessment Scale (ESAS)
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.
Time frame
Baseline to 6 weeks3
Respiratory Complications
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.
Time frame
Baseline to 12 weeks4
Quality of Life of participants evaluated by Euqol-5Dimensions questionnaire
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.
Time frame
Baseline to 6 weeksSecondary outcomes
1
Cardiorespiratory Capacity evaluated using 6 Minutes Walking test
Changes in cardiorespiratory capacity will be evaluated using standardized functional or physiological assessments appropriate for patients with chronic kidney disease, aiming to determine whether the intervention improves respiratory and exercise-related capacity. The Six-Minute Walk Test (6MWT) measures functional exercise capacity by recording the total distance walked in six minutes, expressed in meters, with higher distances indicating better functional performance. There is no fixed minimum or maximum value, as results depend on the individual's physical capacity and clinical condition.
Time frame
Baseline to 6 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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