An interventional study of Controlled breathing exercise protocol + therapeutic exercise + initial education session and Therapeutic exercise + initial education session in Multiple Myeloma (MM), Breathing Techniques and Breathing Exercises, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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.
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:
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 26 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Medical risk contraindicating exercise or breathing techniques:
High musculoskeletal or bone risk:
Hematologic or systemic conditions contraindicating exercise:
Functional or procedural limitations:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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
* 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
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.
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.
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).
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 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).
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
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).
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
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).
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
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).
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
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).
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
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).
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
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).
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.
Lower-Limb Strength
The 30-Second Sit-to-Stand test (30STS) will be used to assess lower-limb strength and endurance. This test has been employed in several studies involving oncology patients.
Time frame: 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)
The same test used to assess lower-limb muscle strength (30STS) will be employed to estimate peak oxygen consumption (VO₂peak). The 30STS has been shown to be a useful tool for estimating VO₂peak in patients with cancer. Its use may facilitate the evaluation and stratification of functional capacity in this population. The formula used to estimate VO₂peak will correspond to the equation known as ONCORE.
Time frame: 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.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 172 non-industry interventional studies with no phase under Multiple Myeloma, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 81. This study's planned 10 months is below that.
Counting every sponsor, half of 186 studies reached it within 38 months; a quarter within 20 and three quarters within 79.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 1, 2026: start Jan 2026 → Feb 2026, primary completion Jun 2026 → Dec 2026 and completion Sep 2026 → Feb 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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