Multiple Myeloma (MM)NCT07376733
Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma
A study testing Therapeutic exercise + initial education session in people with Multiple Myeloma (MM) and Breathing Techniques, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Breathing Techniques, Breathing Exercises
- What is being tested?
- Therapeutic exercise + initial education session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 11 Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Isidro Fernández López, 625598970, isidrofe@ucm.es
About this study
Official title: Efficacy of a Controlled Breathing and Therapeutic Exercise Program on Cardiorespiratory Variables in Patients With Multiple Myeloma
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.
Read the detailed description
Randomized, parallel, double-blind, controlled clinical trial including participants with a confirmed medical diagnosis of multiple myeloma who are currently receiving active treatment with daratumumab and are under clinical follow-up by the Hospital Hematology Department.
Participants will be randomly assigned to one of two intervention groups:
- Control group: Therapeutic exercise + an initial educational session on proper breathing.
- Experimental group: Therapeutic exercise + an initial educational session on proper breathing + a home-based controlled breathing exercise protocol.
Both groups will undergo their respective intervention programs for 6 weeks. During each of the six weeks, participants will:
Perform three weekly sessions of mobility and muscle-strengthening exercises (two supervised on-site sessions and one home-based session). The on-site sessions will last 30-40 minutes and will be conducted at the Rehabilitation Department of Hospital 12 de Octubre in Madrid (a total of 12 on-site sessions, two per week). The weekly home-based session will consist of a structured session replicating the content and methodology of the supervised program.
Walk a minimum of 7,000 steps per day or 50 minutes per day, at least three days per week.
Participants assigned to the experimental group will additionally perform a controlled breathing protocol twice daily at home, following the recommendations of the principal investigator. Furthermore, they will complete two in-person controlled breathing training sessions, each lasting 5 minutes, at the hospital to ensure correct execution of the technique-one at the beginning of the intervention and one at its completion.
The variables to be assessed will include heart rate variability (HRV) indicators (SDNN, RMSSD, HF), heart rate, lower limb strength assessed using the 30-Second Sit-to-Stand Test (30STS), and estimated peak oxygen consumption (VO₂peak). All outcome measures will be evaluated at baseline, at the end of the 6-week intervention, and 4 weeks after completion of the intervention.
In addition, heart rate variability indicators and heart rate will be assessed immediately before and after the two in-person controlled breathing training sessions. as well as before and after an additional reinforcement session conducted four weeks after completion of the intervention. This will allow evaluation of the acute response of these variables to the breathing protocol, compared with participants in the control group, who will be instructed to breathe spontaneously, maintaining their habitual breathing pattern without any external guidance during the same time period.
- Conditions
- Multiple Myeloma (MM), Breathing Techniques, Breathing Exercises, Exercise Activity, Diaphragmatic Breathing, Heart Rate Variability (HRV)
- Being tested
- Controlled breathing exercise protocol + therapeutic exercise + initial education session, Therapeutic exercise + initial education session
- Keywords
- multiple myeloma, Breathing, Diaphragmatic breathing, Slow breathing, exercise activity, Breathing exercises, heart rate variability
- Medical subject headings
- Multiple Myeloma, Respiratory Aspiration, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled breathing exercise protocol + therapeutic exercise + initial education sessionOther
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 sessionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Therapeutic exercise + initial education session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The standard deviation of normal R-R intervals (SDNN) is a heart rate variability (HRV) index that represents overall HRV activity in the time domain; higher values indicate greater overall HRV activity.
This variable will be assessed before and after the two in-person 5-minute controlled breathing training sessions, as well as before and after an additional reinforcement session conducted four weeks after completion of the intervention. This design will allow evaluation of the temporal evolution of these variables in response to the breathing protocol, compared with participants in the control group, who will be instructed during the same time periods to breathe spontaneously, maintaining their usual breathing pattern without any external guidance.
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).
Measured: -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
The root mean square of successive differences between R-R intervals (RMSSD) is a heart rate variability (HRV) index that correlates with vagally mediated regulation.
This variable will be assessed before and after the two in-person 5-minute controlled breathing training sessions, as well as before and after an additional reinforcement session conducted four weeks after completion of the intervention. This design will allow evaluation of the temporal evolution of these variables in response to the breathing protocol, compared with participants in the control group, who will be instructed during the same time periods to breathe spontaneously, maintaining their usual breathing pattern without any external guidance.
Two measurement systems will be used concurrently to assess HRV RMSSD and to evaluate agreement between methods:
- Handheld portable electrocardiograph.
- Heart rate and HRV monitor with chest-worn sensor (Polar H10).
Measured: -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
High frequency (HF) is a heart rate variability (HRV) index that represents parasympathetic nervous system activity in the frequency domain.
This variable will be assessed before and after the two in-person 5-minute controlled breathing training sessions, as well as before and after an additional reinforcement session conducted four weeks after completion of the intervention. This design will allow evaluation of the temporal evolution of these variables in response to the breathing protocol, compared with participants in the control group, who will be instructed during the same time periods to breathe spontaneously, maintaining their usual breathing pattern without any external guidance.
Two measurement systems will be used concurrently to assess HRV HF and to evaluate agreement between methods:
- Handheld portable electrocardiograph.
- Heart rate and HRV monitor with chest-worn sensor (Polar H10).
Measured: -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
This variable will be assessed before and after the two in-person 5-minute controlled breathing training sessions, as well as before and after an additional reinforcement session conducted four weeks after completion of the intervention. This design will allow evaluation of the temporal evolution of these variables in response to the breathing protocol, compared with participants in the control group, who will be instructed during the same time periods to breathe spontaneously, maintaining their usual breathing pattern without any external guidance.
Two measurement systems will be used concurrently to assess HR and to evaluate agreement between methods. Heart rate (HR) will be assessed using the mean value obtained over the 5-minute recording period from both measurement systems employed. These two systems are:
- Handheld portable electrocardiograph.
- Heart rate and HRV monitor with chest-worn sensor (Polar H10).
Measured: -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
Heart rate (HR) will be assessed using the mean value obtained over the 5-minute recording period from both measurement systems employed. These two systems are:
- Handheld portable electrocardiograph.
- Heart rate and HRV monitor with chest-worn sensor (Polar H10).
Measured: 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.
HRV RMSSD pre-postintervention
The root mean square of successive differences between R-R intervals (RMSSD) is a heart rate variability (HRV) index that correlates with vagally mediated regulation. Two measurement systems will be used concurrently to assess HRV RMSSD and to evaluate agreement between methods:
- Handheld portable electrocardiograph.
- Heart rate and HRV monitor with chest-worn sensor (Polar H10).
Measured: 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.
HRV HF pre-postintervention
High frequency (HF) is a heart rate variability (HRV) index that represents parasympathetic nervous system activity in the frequency domain; lower values indicate anxiety or stress, whereas higher values suggest a state of relaxation. Two measurement systems will be used concurrently to assess HRV HF and to evaluate agreement between methods:
- Handheld portable electrocardiograph.
- Heart rate and HRV monitor with chest-worn sensor (Polar H10).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start11 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isidro Fernández López, Universidad Complutense de Madrid
- Investigators
- Gustavo Plaza-Manzano, PhD, Study director, Faculty of Nursing, Physiotherapy and Podiatry. Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376733
- Sponsor's protocol ID
- Cardiorespiratory Mieloma
- Status last verified
- Sep 2026
- First submitted
- 21 Jan 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diaz-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.
PubMed 35819522Insulander 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.
PubMed 32101067Luna-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.
PubMed 38812020Li 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.
PubMed 40490782Nicol 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.
PubMed 36450625Fournie 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.
PubMed 34636946Shahriari 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.
PubMed 28546966
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Controlled Breathing and Therapeutic Exercise Program on Cardiorespiratory Variables in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07376733
- Acronym / sponsor ID
- Cardiorespiratory Mieloma
- Conditions
- Multiple Myeloma (MM), Breathing Techniques, Breathing Exercises, Exercise Activity, Diaphragmatic Breathing, Heart Rate Variability (HRV)
- Keywords
- multiple myeloma, Breathing, Diaphragmatic breathing, Slow breathing, exercise activity, Breathing exercises, heart rate variability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized, parallel, double-blind, controlled clinical trial including participants with a confirmed medical diagnosis of multiple myeloma who are currently receiving active treatment with daratumumab and are under clinical follow-up by the Hospital Hematology Department.
Participants will be randomly assigned to one of two intervention groups:
- Control group: Therapeutic exercise + an initial educational session on proper breathing.
- Experimental group: Therapeutic exercise + an initial educational session on proper breathing + a home-based controlled breathing exercise protocol.
Both groups will undergo their respective intervention programs for 6 weeks. During each of the six weeks, participants will:
Perform three weekly sessions of mobility and muscle-strengthening exercises (two supervised on-site sessions and one home-based session). The on-site sessions will last 30-40 minutes and will be conducted at the Rehabilitation Department of Hospital 12 de Octubre in Madrid (a total of 12 on-site sessions, two per week). The weekly home-based session will consist of a structured session replicating the content and methodology of the supervised program.
Walk a minimum of 7,000 steps per day or 50 minutes per day, at least three days per week.
Participants assigned to the experimental group will additionally perform a controlled breathing protocol twice daily at home, following the recommendations of the principal investigator. Furthermore, they will complete two in-person controlled breathing training sessions, each lasting 5 minutes, at the hospital to ensure correct execution of the technique-one at the beginning of the intervention and one at its completion.
The variables to be assessed will include heart rate variability (HRV) indicators (SDNN, RMSSD, HF), heart rate, lower limb strength assessed using the 30-Second Sit-to-Stand Test (30STS), and estimated peak oxygen consumption (VO₂peak). All outcome measures will be evaluated at baseline, at the end of the 6-week intervention, and 4 weeks after completion of the intervention.
In addition, heart rate variability indicators and heart rate will be assessed immediately before and after the two in-person controlled breathing training sessions. as well as before and after an additional reinforcement session conducted four weeks after completion of the intervention. This will allow evaluation of the acute response of these variables to the breathing protocol, compared with participants in the control group, who will be instructed to breathe spontaneously, maintaining their habitual breathing pattern without any external guidance during the same time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise + initial education session + home-based controlled breathing exercise protocol | Experimental | Other: Controlled breathing exercise protocol + therapeutic exercise + initial education session* 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. |
| Therapeutic exercise + initial educational session on proper breathing | Active comparator | Other: Therapeutic exercise + initial education session* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- Medical risk contraindicating exercise or breathing techniques:
- High musculoskeletal or bone risk:
- Hematologic or systemic conditions contraindicating exercise:
- Functional or procedural limitations:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled breathing exercise protocol + therapeutic exercise + initial education sessionIn 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. | Other | Therapeutic exercise + initial education session + home-based controlled breathing exercise protocol |
| Therapeutic exercise + initial education sessionIn 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. | Other | Therapeutic exercise + initial educational session on proper breathing |
Primary outcome
HRV SDNN pre-postintervention
Time frame: 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).
7 secondary outcomes
HRV SDNN In-person controlled breathing intervention
Time frame: -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
Time frame: -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
Time frame: -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
Time frame: -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
Time frame: 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.
HRV RMSSD pre-postintervention
Time frame: 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.
HRV HF pre-postintervention
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 35819522Diaz-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.
- Background: PubMed 32101067Insulander 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.
- Background: PubMed 38812020Luna-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.
- Background: PubMed 40490782Li 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.
- Background: PubMed 36450625Nicol 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.
- Background: PubMed 34636946Fournie 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.
- Background: PubMed 28546966Shahriari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gustavo Plaza-Manzano, PhD study director
Faculty of Nursing, Physiotherapy and Podiatry. Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercise + initial education session in people with Multiple Myeloma (MM) and Breathing Techniques, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isidro Fernández-López, PhD (+34625598970, isidrofe@ucm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRV SDNN pre-postintervention (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376733, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.