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.
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).
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).
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.
Parallel
Controlled breathing exercise protocol + therapeutic exercise + initial education session
Other interventionIn 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
Other interventionIn 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).
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).
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).
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).
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).
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.
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.
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