Clinical trial · Interventional
Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma
Effects of Adding a Controlled Breathing Protocol to a Therapeutic Exercise Program in Adults 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, multicenter clinical trial with two intervention arms. 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 somatic symptoms in individuals with multiple myeloma
Conditions
Conditions (5)
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 | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
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
- 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.
- interventionNames
- Other: Therapeutic exercise + initial education session
- 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. * 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)
- BACKGROUNDShahriari M, Dehghan M, Pahlavanzadeh S, Hazini A. Effects of progressive muscle relaxation, guided imagery and deep diaphragmatic breathing on quality of life in elderly with breast or prostate cancer. J Educ Health Promot. 2017 Apr 19;6:1. doi: 10.4103/jehp.jehp_147_14. eCollection 2017. PMID 28546966
- 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. PMID 34636946
- BACKGROUNDDhruva A, Miaskowski C, Abrams D, Acree M, Cooper B, Goodman S, Hecht FM. Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. J Altern Complement Med. 2012 May;18(5):473-9. doi: 10.1089/acm.2011.0555. Epub 2012 Apr 23. PMID 22525009
- BACKGROUNDShao R, Man ISC, Lee TMC. The Effect of Slow-Paced Breathing on Cardiovascular and Emotion Functions: A Meta-Analysis and Systematic Review. Mindfulness. 2024;15(1):1-18. doi:10.1007/s12671-023-02294-2
- 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
- BACKGROUNDMoller MD, Ihorst G, Pahl A, Scheubeck S, Barsch F, Dold SM, Bertz H, Arends J, Wasch R, Engelhardt M. Physical activity is associated with less comorbidity, better treatment tolerance and improved response in patients with multiple myeloma undergoing stem cell transplantation. J Geriatr Oncol. 2021 May;12(4):521-530. doi: 10.1016/j.jgo.2020.11.003. Epub 2020 Nov 20. PMID 33223484
- Li 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.