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
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).
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.
Severe anemia: hemoglobin < 9 g/dL in women or < 8 g/dL in men (latest laboratory test ≤ 14 days).
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. 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 respiratory control-based interventions, and were reviewed and approved by the entire research team.
Therapeutic exercise + initial education session
Other interventionIn addition to the therapeutic exercise protocol and 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.
Somatic Symptom Questionnaire
The PHQ-15 will be used to assess the number of somatic symptoms and the degree of distress experienced during the past four weeks. Cancer survivors with a greater number of somatic symptoms tend to report higher levels of stress, partly due to increased fear of disease recurrence or progressio
Global quality of life
Global quality of life will be assessed using the EORTC-QLQ C30 Version 3.0 questionnaire, developed by the European Organization for Research and Treatment of Cancer (EORTC), a cancer-specific instrument that has been extensively validated in both its English and Spanish versions
Sleep Quality Questionnaire
The Pittsburgh Sleep Quality Index (PSQI) will be used in its validated Spanish version, which provides a global sleep quality score as well as partial scores across seven distinct components
Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) will be used to assess these symptoms among study participants. This screening instrument has been widely used and validated as a brief tool for detecting depressive and anxiety symptoms in oncology patients
Fatigue
The Brief Fatigue Inventory (BFI) will be used to assess fatigue; it is a reliable instrument that allows for rapid evaluation of fatigue levels in cancer patients, and its Spanish version has also been validated
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