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Recruiting NCT07312942

Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma

Conditions: Multiple Myeloma, Breathing Techniques, Breathing Exercises, Exercise Activity, Diaphragmatic Breathing

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Universidad Complutense de Madrid

Location: Hospital Universitario 12 de Octubre Madrid

Summary

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

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07312942). StuddyBuddy aggregates publicly available trial information.