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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Participants will receive diaphragmatic biofeedback combined with respiratory muscle training three times per day for 6 weeks |
|
| Control Arm | Placebo Comparator | Placebo intervention based on conscious breathing three times per day for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic biofeedback combined with respiratory muscle training | Other | 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 muscle training approaches. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 weeks |
| 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. | Baseline to 6 weeks |
| 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. | Baseline to 12 weeks |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie Carmen Valenza, PhD University Professor | Contact | 958248035 | +34 | cvalenza@ugr.es |
| Name | Affiliation | Role |
|---|---|---|
| Alejandro Heredia-Ciuró, PhD | Universidad de Granada | Principal Investigator |
| Marie Carmen Valenza, PhD | Universidad de Granada | Study Director |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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|
| PLACEBO INTERVENTION | Other | 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. |
|
| Baseline to 6 weeks |
| Acceptability of intervention considering number of sessions completed by participant | Acceptability of diaphragmatic biofeedback added to respiratory muscle training will be assessed through participant completion rates. | 6 weeks |
| Baseline to 6 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026741 |
| Physical Therapy Modalities |