Clinical trial · Interventional
Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma
Efficacy of a Controlled Breathing and Therapeutic Exercise Program on Cardiorespiratory Variables in Patients With Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breathing Exercises | — | UNRESOLVED | — |
| Breathing Techniques | — | UNRESOLVED | — |
| Diaphragmatic Breathing | — | UNRESOLVED | — |
| Exercise Activity | — | UNRESOLVED | — |
| Heart Rate Variability (HRV) | — | UNRESOLVED | — |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Controlled breathing exercise protocol + therapeutic exercise + initial education session | Other | — | UNRESOLVED |
| Therapeutic exercise + initial education session | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Therapeutic exercise + initial education session + home-based controlled breathing exercise protocol
- description
- * 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. Additionally, within this same group, two in-person controlled breathing training sessions, each lasting 5 minutes, will be conducted at the hospital. * Perform three weekly sessions of mobility and muscle-strengthening exercises (two on-site and one home-based) for 6 weeks. 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. * Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week. * All participants will receive an initial educational session and an explanatory leaflet outlining the fundamental principles of functional breathing.
- interventionNames
- Other: Controlled breathing exercise protocol + therapeutic exercise + initial education session
- type
- ACTIVE_COMPARATOR
- label
- Therapeutic exercise + initial educational session on proper breathing
- description
- * Perform three weekly sessions of mobility and muscle-strengthening exercises (two on-site and one home-based) for 6 weeks. 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. * Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week. * To promote adherence to the protocol and standardize basic knowledge regarding the breathing technique, all participants will receive an initial educational session delivered on the first day of the on-site intervention. This session will include an introductory lecture and an explanatory leaflet outlining the fundamental principles of functional breathing and its relevance to the intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDDiaz-Balboa E, Gonzalez-Salvado V, Rodriguez-Romero B, Martinez-Monzonis A, Pedreira-Perez M, Cuesta-Vargas AI, Lopez-Lopez R, Gonzalez-Juanatey JR, Pena-Gil C. Thirty-second sit-to-stand test as an alternative for estimating peak oxygen uptake and 6-min walking distance in women with breast cancer: a cross-sectional study. Support Care Cancer. 2022 Oct;30(10):8251-8260. doi: 10.1007/s00520-022-07268-z. Epub 2022 Jul 11. PMID 35819522
- BACKGROUNDInsulander P, Carnlof C, Schenck-Gustafsson K, Jensen-Urstad M. Device profile of the Coala Heart Monitor for remote monitoring of the heart rhythm: overview of its efficacy. Expert Rev Med Devices. 2020 Mar;17(3):159-165. doi: 10.1080/17434440.2020.1732814. Epub 2020 Feb 26. PMID 32101067
- BACKGROUNDLuna-Alcala S, Espejel-Guzman A, Lerma C, Leon P, Guerra EC, Fernandez JRE, Martinez-Dominguez P, Serrano-Roman J, Cabello-Ganem A, Aparicio-Ortiz AD, Keirns C, Lerma A, Ana-Bayona MJS, Espinola-Zavaleta N. Heart rate variability-based prediction of early cardiotoxicity in breast-cancer patients treated with anthracyclines and trastuzumab. Cardiooncology. 2024 May 29;10(1):32. doi: 10.1186/s40959-024-00236-y. PMID 38812020
- BACKGROUNDLi J, Peng Y, Zhan D, Zhang Y, Yu S. Exercise interventions in patients with multiple myeloma: a scoping review. BMC Sports Sci Med Rehabil. 2025 Jun 9;17(1):148. doi: 10.1186/s13102-025-01193-4. PMID 40490782
- BACKGROUNDNicol JL, Chong JE, McQuilten ZK, Mollee P, Hill MM, Skinner TL. Safety, Feasibility, and Efficacy of Exercise Interventions for People With Multiple Myeloma: A Systematic Review. Clin Lymphoma Myeloma Leuk. 2023 Feb;23(2):86-96. doi: 10.1016/j.clml.2022.10.003. Epub 2022 Oct 22. PMID 36450625
- BACKGROUNDFournie C, Verkindt C, Dalleau G, Bouscaren N, Mohr C, Zunic P, Cabrera Q. Rehabilitation program combining physical exercise and heart rate variability biofeedback in hematologic patients: a feasibility study. Support Care Cancer. 2022 Mar;30(3):2009-2016. doi: 10.1007/s00520-021-06601-2. Epub 2021 Oct 12.