Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma

Starting soon · Not applicable

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

In brief

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

Key facts

Study ID

NCT07312942

Run by

Universidad Complutense de Madrid

People needed

32

Starts

2026-01-01

Expected to finish

2026-07-01

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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