Respiratory Biofeedback Added to Strengthening Training in Patients With Chronic Kidney Disease (RESPI-REN)

University of Granada (UGR)

Status: Not yet enrolling

Conditions: Chronic Kidney Disease (Stages 4 and 5)

Treatments: Other: PLACEBO INTERVENTION; Other: Diaphragmatic biofeedback combined with respiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT07369973

SICEIA-2024-003384

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Treatment Arm

Experimental group

Description:

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

Treatment:

Other: Diaphragmatic biofeedback combined with respiratory muscle training

Control Arm

Placebo Comparator group

Description:

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

Treatment:

Other: PLACEBO INTERVENTION