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

NCT07369973 | Not Yet Recruiting

• 1 other identifier: SICEIA-2024-003384
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Kidney Disease (Stages 4 and 5)

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (1)

• Cardiorespiratory Capacity evaluated using 6 Minutes Walking test

  Baseline to 6 weeks

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Participants will receive diaphragmatic biofeedback combined with respiratory muscle training three times per day for 6 weeks

Other: Diaphragmatic biofeedback combined with respiratory muscle training

Control Arm

PLACEBO COMPARATOR

Placebo intervention based on conscious breathing three times per day for 6 weeks

Other: PLACEBO INTERVENTION

Interventions

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.

Treatment Arm

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.

Control Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Alejandro Heredia-Ciuró, PhD

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

• Marie Carmen Valenza, PhD

  Universidad de Granada

  STUDY DIRECTOR

Central Study Contacts

Marie Carmen Valenza, PhD University Professor

CONTACT

958248035; cvalenza@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 27, 2026
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01