Chronic Kidney Disease (Stages 4 and 5)RESPI-RENNCT07369973
Respiratory Biofeedback Added to Strengthening Training in Patients With Chronic Kidney Disease
A study testing Diaphragmatic biofeedback combined with respiratory muscle training in people with Chronic Kidney Disease (Stages 4 and 5), run by Universidad de Granada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5)
- What is being tested?
- Diaphragmatic biofeedback combined with respiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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)
- Being tested
- Diaphragmatic biofeedback combined with respiratory muscle training, PLACEBO INTERVENTION
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic biofeedback combined with respiratory muscle trainingOther
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 INTERVENTIONOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will receive diaphragmatic biofeedback combined with respiratory muscle training three times per day for 6 weeks Receives: 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 Receives: Other: PLACEBO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary 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.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Alejandro Heredia-Ciuró, PhD, Principal investigator, Universidad de GranadaMarie Carmen Valenza, PhD, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369973
- Sponsor's protocol ID
- SICEIA-2024-003384
- Acronym
- RESPI-REN
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Biofeedback Added to Strengthening Training in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07369973
- Acronym / sponsor ID
- RESPI-REN / SICEIA-2024-003384
- Conditions
- Chronic Kidney Disease (Stages 4 and 5)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Diaphragmatic biofeedback combined with respiratory muscle trainingParticipants will receive diaphragmatic biofeedback combined with respiratory muscle training three times per day for 6 weeks |
| Control Arm | Placebo comparator | Other: PLACEBO INTERVENTIONPlacebo intervention based on conscious breathing three times per day for 6 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic biofeedback combined with respiratory muscle trainingThis 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. | Other | Treatment Arm |
| PLACEBO 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. | Other | Control Arm |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Cardiorespiratory Capacity evaluated using 6 Minutes Walking test
Time frame: Baseline to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Heredia-Ciuró, PhD principal investigator
Universidad de Granada
Marie Carmen Valenza, PhD study director
Universidad de Granada
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic biofeedback combined with respiratory muscle training in people with Chronic Kidney Disease (Stages 4 and 5), run by Universidad de Granada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD University Professor (958248035 ext. +34, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events during intervention sessions (time frame: Baseline to 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.