Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma

NCT07376733 | Not Yet Recruiting

• 1 other identifier: Cardiorespiratory Mieloma
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breathing Techniques; Breathing Exercises; Exercise Activity; Diaphragmatic Breathing; Heart Rate Variability (HRV); Multiple Myeloma (MM)

Keywords

multiple myeloma; Breathing; Diaphragmatic breathing; Slow breathing; exercise activity; Breathing exercises; heart rate variability

Outcome Measures

Primary Outcomes (1)

• HRV SDNN pre-postintervention

  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).

  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.

Secondary Outcomes (7)

• HRV SDNN In-person controlled breathing intervention

  -First measurement: before and after the first in-person breathing training session.-Second measurement (week 6): before and after the second in-person breathing training session.-Third measurement (week 10): before and after the reinforcement session

• HRV RMSSD In-person controlled breathing intervention

  -First measurement: before and after the first in-person breathing training session.-Second measurement (week 6): before and after the second in-person breathing training session.-Third measurement (week 10): before and after the reinforcement session.

• HRV HF In-person controlled breathing intervention

  -First measurement: before and after the first in-person breathing training session.-Second measurement (week 6): before and after the second in-person breathing training session.-Third measurement (week 10): before and after the reinforcement session.

• Heart Rate In-person controlled breathing intervention

  -First measurement: before and after the first in-person breathing training session.-Second measurement (week 6): before and after the second in-person breathing training session.-Third measurement (week 10): before and after the reinforcement session.

• Heart Rate 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.

Other Outcomes (2)

• Lower-Limb Strength

  Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

• Estimated Peak Oxygen Consumption (VO₂peak)

  Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

Study Arms (2)

Therapeutic exercise + initial education session + home-based controlled breathing exercise protocol

EXPERIMENTAL

* 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.

Other: Controlled breathing exercise protocol + therapeutic exercise + initial education session

Therapeutic exercise + initial educational session on proper breathing

ACTIVE COMPARATOR

* 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.

Other: Therapeutic exercise + initial education session

Interventions

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

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 + home-based controlled breathing exercise protocol

Therapeutic exercise + initial education session OTHER

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.

Therapeutic exercise + initial educational session on proper breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Related Publications (7)

• Díaz-Balboa E, González-Salvado V, Rodríguez-Romero B, et al. 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;30(10):8251-8260. doi:10.1007/s00520-022-07268-z

  BACKGROUND

• Insulander P, Carnlöf 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;17(3):159-165. doi:10.1080/17434440.2020.1732814

  BACKGROUND

• Luna-Alcala S, Espejel-Guzmán A, Lerma C, et al. Heart rate variability-based prediction of early cardiotoxicity in breast-cancer patients treated with anthracyclines and trastuzumab. Cardiooncology. 2024;10(1):32. doi:10.1186/s40959-024-00236-y

  BACKGROUND

• 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.

  PMID: 40490782 BACKGROUND

• Nicol 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 BACKGROUND

• Fournie 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 BACKGROUND

• Shahriari 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 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Respiratory Aspiration; Hypoventilation

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Gustavo Plaza-Manzano, PhD

  Faculty of Nursing, Physiotherapy and Podiatry. Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Isidro Fernández-López, PhD

CONTACT

+34625598970; isidrofe@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Only the principal investigator will have access to the randomization sequence, thereby maintaining blinding for the rest of the team involved in data collection. Both groups will receive the same therapeutic exercise program and an educational session with a standardized educational leaflet on the importance of physical activity and proper breathing in daily life, with the aim of minimizing differences in the perceived intervention. The study will include evaluator blinding, as all assessments will be carried out by an independent investigator who is not involved in the randomization process and is unaware of participants' group allocation. Additionally, statistical analyses will be conducted by a specialized statistician, also blinded to group assignment, thereby ensuring impartiality in the analysis and interpretation of the results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, parallel, double-blind, controlled clinical trial. Two groups of participants will be included, both receiving an educational session with a standardized educational leaflet on the importance of proper breathing, and a therapeutic exercise intervention 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. For heart rate and heart rate variability variables, two assessments will be conducted at identical time points to determine the immediate within-session effect of the in-person breathing session, compared with participants in the control group, who will be instructed to breathe spontaneously while maintaining their usual breathing pattern.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: January 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01