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NCT Number: NCT07369973

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

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

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Key information

Conditions

Chronic Kidney Disease (stages 4 and 5) Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of participants with treatment-related adverse events during intervention sessions

    Time frame: 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.

  2. Respiratory Symptoms assessed by Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 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.

  3. Respiratory Complications

    Time frame: 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.

  4. Quality of Life of participants evaluated by Euqol-5Dimensions questionnaire

    Time frame: 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.

  5. Acceptability of intervention considering number of sessions completed by participant

    Time frame: 6 weeks

    Acceptability of diaphragmatic biofeedback added to respiratory muscle training will be assessed through participant completion rates.

Secondary outcomes

  1. Cardiorespiratory Capacity evaluated using 6 Minutes Walking test

    Time frame: Baseline to 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Carmen Valenza, PhD University Professor

CONTACT

[email protected]

958248035 ext. +34

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Acronym: RESPI-REN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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