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Effets de la respiration contrôlée ajoutée à l'exercice thérapeutique dans le myélome multiple

28 septembre 2026 mis à jour par: Isidro Fernández López, Universidad Complutense de Madrid

Effets de l'ajout d'un protocole de respiration contrôlée à un programme d'exercices thérapeutiques chez les adultes atteints de myélome multiple

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Randomized, parallel, double-blind, controlled clinical trial in which two groups of participants will be included and randomly assigned to one of the two intervention arms:

Therapeutic exercise + initial educational session on proper breathing.

Therapeutic exercise + initial educational session on proper breathing + home-based controlled breathing exercise protocol.

The therapeutic exercise and controlled breathing program will last 6 weeks. During this period, 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.

Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week.

Perform a controlled breathing protocol twice per day at home during 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.

The variables to be assessed will include: somatic symptom questionnaire, quality of life, sleep quality, fatigue, anxiety and depression symptoms.

These variables will be evaluated at baseline, at the end of the 6-week intervention period, and again 4 weeks after completing the intervention.

Type d'étude

Interventionnel

Inscription (Estimé)

32

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Isidro Fernández-López, PhD
  • Numéro de téléphone: +34625598970
  • E-mail: isidrofe@ucm.es

Lieux d'étude

  • Espagne
      • Madrid, Espagne, 28041
        • Recrutement
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Isidro Fernández López
          • Numéro de téléphone: +34625598970
          • E-mail: isidrofe@ucm.es

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Therapeutic exercise + initial educational session on proper breathing
  • Perform three weekly sessions of mobility and muscle-strengthening exercises (two on-site and one home-based) for 6 weeks. 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.
  • Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week.
  • To promote adherence to the protocol and standardize basic knowledge regarding the breathing technique, all participants will receive an initial educational session delivered on the first day of the on-site intervention. This session will include an introductory lecture and an explanatory leaflet outlining the fundamental principles of functional breathing and its relevance to the intervention.
Autre: Therapeutic exercise + initial education session

In 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.

Autres noms:
  • exercice thérapeutique
  • session éducative sur la respiration correcte
Expérimental: Therapeutic exercise + initial education session + home-based controlled breathing exercise protocol
  • 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.
  • Perform three weekly sessions of mobility and muscle-strengthening exercises (two on-site and one home-based) for 6 weeks. 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.
  • Walk a minimum of 7,000 steps/day or 50 minutes/day, three days per week.
  • To promote adherence to the protocol and standardize basic knowledge regarding the breathing technique, all participants will receive an initial educational session delivered on the first day of the on-site intervention. This session will include an introductory lecture and an explanatory leaflet outlining the fundamental principles of functional breathing and its relevance to the intervention.
Autre: Controlled breathing exercise protocol + therapeutic exercise + initial education session

In 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.

Autres noms:
  • Exercice thérapeutique
  • session éducative sur la respiration correcte

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Somatic Symptom Questionnaire
Délai: Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

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
Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Global quality of life
Délai: Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

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
Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.
Sleep Quality Questionnaire
Délai: Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

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
Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.
Anxiety and Depression Scale
Délai: Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

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
Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Fatigue
Délai: Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

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
Information for this variable will be collected at three time points: at baseline, at the end of the intervention (6 weeks), and four weeks after completion of the protocol.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Universidad Complutense de Madrid

Les enquêteurs

  • Directeur d'études: Gustavo Plaza-Manzano, PhD, Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry. Universidad Complutense de Madrid

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 janvier 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 mars 2027

Dates d'inscription aux études

Première soumission

17 décembre 2025

Première soumission répondant aux critères de contrôle qualité

17 décembre 2025

Première publication (Réel)

31 décembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Breathing Mieloma

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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