Adding Controlled Breathing to Exercise for People With Multiple Myeloma

Trial details

Who runs it

Universidad Complutense de Madrid

Trial code

NCT07312942

Record updated

1 October 2026

Original description

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.Read full original descriptionShow less

Effects of Adding a Controlled Breathing Protocol to a Therapeutic Exercise Program in Adults With Multiple Myeloma

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

Inclusion: 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: 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); 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; 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; 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.

ClinicalTrials.gov NCT07312942