Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma

NCT07376733 · tracked via the Priya Life Science Spain tracker

Sponsor

Universidad Complutense de Madrid

Phase

Not applicable

Started

2026-02-11

Last updated

2026-10-01

Condition(s) studied

Multiple Myeloma (MM)Breathing TechniquesBreathing ExercisesExercise ActivityDiaphragmatic BreathingHeart Rate Variability (HRV)

Investigational drug(s) / intervention(s)

Controlled breathing exercise protocol + therapeutic exercise + initial education sessionTherapeutic exercise + initial education session

Controlled breathing exercise protocol + therapeutic exercise + initial education session: In addition to the therapeutic exercise protocol and the educational session on proper breathing, participants will perform a controlled breathing protocol at home twice daily, at least five days per week, throughout the 6-week study period, following the recommendations of the principal investigator. The goal is to integrate slow, gentle, diaphragmatic, nasal breathing into daily life. Additionally, within this same group, two in-person controlled breathing training sessions, each lasting 5 minutes, will be conducted at the hospital to promote correct execution of the technique, one at the beginning of the intervention and another at its completion. To promote adherence and ensure correct and consistent execution, participants will have access through the Web-App to two audio files containing guided breathing instructions and visualization exercises. These recordings were specifically developed for this project by a physiotherapist with more than 20 years of experience.

Therapeutic exercise + initial education session: In addition to the educational session on proper breathing, participants will perform: * Three weekly sessions of mobility and muscle-strengthening exercises (two on-site and one home-based) for 6 weeks. The on-site sessions will last between 30 and 40 minutes and will take place at the Rehabilitation Department of Hospital 12 de Octubre in Madrid (a total of 12 on-site sessions-two per week). The home-based exercise program will consist of completing, once per week during the 6-week intervention, a structured session that replicates the logic and technique of the on-site program. A maximum of four absences from the on-site therapeutic exercise program will be allowed, and on those occasions the patient must register via the web application that they completed the prescribed home-based program. * Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week.

Study summary

A randomized, parallel, double-blind, controlled, clinical trial. Two groups of participants will be included, both receiving a therapeutic exercise intervention and an educational session on the importance of proper breathing over a 6-week period. One of the groups will additionally perform a home-based controlled breathing exercise protocol. Pre- and post-intervention assessments (6 weeks) will be conducted, along with a follow-up evaluation 4 weeks after completion of the intervention. The goal is to determine the effectiveness of adding a controlled breathing exercise program to a therapeutic exercise intervention on cardiorespiratory variables in individuals with multiple myeloma.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥ 18 years. * Confirmed diagnosis of multiple myeloma, currently undergoing active treatment with daratumumab, and under clinical follow-up by the Hematology Department of HU12O. * Explicit medical indication for supervised physical activity issued by the responsible hematologist and documented in the medical record. * No scheduled hematopoietic stem cell transplantation within the 60 days following the planned start date of the intervention (verified through medical record review). * Functional status of ECOG 0-2 (Eastern Cooperative Oncology Group), assessed by a healthcare professional from the Hematology Department, ensuring the ability to perform at least basic and light instrumental activities of daily living, including independent ambulation. * Access to a smartphone with stable internet connection, required for monitoring and recording adherence to the intervention. * Ability to provide written informed consent, demonstrating understanding of the study's nature, purpose, and procedures. Exclusion Criteria: * Medical risk contraindicating exercise or breathing techniques: * Clinically significant cardiovascular disease, including:decompensated heart failure, acute myocardial infarction within the past 3 months, clinically uncontrolled arrhythmias, unstable angina, acute-phase deep vein thrombosis or pulmonary embolism, pacemakers or cardiac devices whose monitoring parameters contraindicate supervised exercise according to cardiology. * Severe decompensated respiratory disease, such as acute exacerbation of COPD, severe respiratory insufficiency, or persistently low resting oxygen saturation \< 90% (not correctable). * High musculoskeletal or bone risk: * Extensive lytic bone lesions, high risk of pathological fracture, or unstable vertebral fracture, documented by imaging or based on the assessment of the Hematology/Traumatology specialist. * Uncontrolled pain that prevents safe participation in an exercise program. * Hematologic or systemic conditions contraindicating exercise: * Severe anemia: hemoglobin \< 9 g/dL in women or \< 8 g/dL in men (latest laboratory test ≤ 14 days). * Active systemic infection contraindicating exercise, fever ≥ 38 °C, or neutropenia \< 0.5 × 10⁹/L. * Severe cytopenias that, in the opinion of the hematologist, preclude moderate exercise. * Functional or procedural limitations: * Inability to remain in the supine position for ≥ 5 minutes, required for part of the breathing intervention. * Confirmed pregnancy or reasonable suspicion of pregnancy. * Severe cognitive impairment, major psychiatric disorders, or neurological diseases that limit understanding of the procedures or safe participation. * Significant difficulty understanding the language (spoken or written) that prevents following essential instructions or completing validated questionnaires.

Primary outcome measure(s)

HRV SDNN pre-postintervention — Baseline measurement: obtained prior to initiation of the training protocol. Second measurement: obtained immediately upon completion of the 6-week protocol.Follow-up: one additional measurement four weeks after completing the intervention protocol.
Two measurement systems will be used concurrently to assess HRV SDNN and to evaluate agreement between methods: * Handheld portable electrocardiograph. * Heart rate and HRV monitor with chest-worn sensor (Polar H10).

Trial sites (1)

Facility	City	Region	Status
Hospital Universitario 12 de Octubre	Madrid	Spain	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07376733 on ClinicalTrials.gov ↗ ← All trials in Spain