[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621908":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":41,"collaborators":25,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":25,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":25,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":68,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":25},{"fullName":5,"class":6},"Universidad Complutense de Madrid","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Therapeutic exercise + initial education session + home-based controlled breathing exercise protocol","EXPERIMENTAL","* 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. Additionally, within this same group, two in-person controlled breathing training sessions, each lasting 5 minutes, will be conducted at the hospital.\n* 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.\n* Walk a minimum of 7,000 steps\u002Fday or 50 minutes\u002Fday, three days per week.\n* All participants will receive an initial educational session and an explanatory leaflet outlining the fundamental principles of functional breathing.",[13],"Other: Controlled breathing exercise protocol + therapeutic exercise + initial education session",{"label":15,"type":16,"description":17,"interventionNames":18},"Therapeutic exercise + initial educational session on proper breathing","ACTIVE_COMPARATOR","* 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.\n* Walk a minimum of 7,000 steps\u002Fday or 50 minutes\u002Fday, three days per week.\n* 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.",[19],"Other: Therapeutic exercise + initial education session",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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. Additionally, within this same group, two in-person controlled breathing training sessions, each lasting 5 minutes, will be conducted at the hospital to promote correct execution of the technique, one at the beginning of the intervention and another at its completion.\n\nTo 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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Therapeutic exercise + initial education session","In addition to the educational session on proper breathing, participants will perform:\n\n* 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.\n* Walk a minimum of 7,000 steps\u002Fday or 50 minutes\u002Fday, three days per week.",[15],[31],{"name":32,"affiliation":33,"role":34},"Gustavo Plaza-Manzano, PhD","Faculty of Nursing, Physiotherapy and Podiatry. Universidad Complutense de Madrid","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Isidro Fernández-López, PhD","CONTACT","+34625598970","isidrofe@ucm.es",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Isidro Fernández López","Principal Investigator","100621908","effects-of-controlled-breathing-on-cardiorespiratory-variables-in-multiple-myeloma-100621908",false,"NCT07376733","Effects of Controlled Breathing on Cardiorespiratory Variables in Multiple Myeloma","Efficacy of a Controlled Breathing and Therapeutic Exercise Program on Cardiorespiratory Variables in Patients With Multiple Myeloma","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed diagnosis of multiple myeloma, currently undergoing active treatment with daratumumab, and under clinical follow-up by the Hematology Department of HU12O.\n* Explicit medical indication for supervised physical activity issued by the responsible hematologist and documented in the medical record.\n* No scheduled hematopoietic stem cell transplantation within the 60 days following the planned start date of the intervention (verified through medical record review).\n* 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.\n* Access to a smartphone with stable internet connection, required for monitoring and recording adherence to the intervention.\n* Ability to provide written informed consent, demonstrating understanding of the study's nature, purpose, and procedures.\n\nExclusion Criteria:\n\n* Medical risk contraindicating exercise or breathing techniques:\n\n  * 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.\n  * Severe decompensated respiratory disease, such as acute exacerbation of COPD, severe respiratory insufficiency, or persistently low resting oxygen saturation \\\u003C 90% (not correctable).\n* High musculoskeletal or bone risk:\n\n  * Extensive lytic bone lesions, high risk of pathological fracture, or unstable vertebral fracture, documented by imaging or based on the assessment of the Hematology\u002FTraumatology specialist.\n  * Uncontrolled pain that prevents safe participation in an exercise program.\n* Hematologic or systemic conditions contraindicating exercise:\n\n  * Severe anemia: hemoglobin \\\u003C 9 g\u002FdL in women or \\\u003C 8 g\u002FdL in men (latest laboratory test ≤ 14 days).\n  * Active systemic infection contraindicating exercise, fever ≥ 38 °C, or neutropenia \\\u003C 0.5 × 10⁹\u002FL.\n  * Severe cytopenias that, in the opinion of the hematologist, preclude moderate exercise.\n* Functional or procedural limitations:\n\n  * Inability to remain in the supine position for ≥ 5 minutes, required for part of the breathing intervention.\n  * Confirmed pregnancy or reasonable suspicion of pregnancy.\n  * Severe cognitive impairment, major psychiatric disorders, or neurological diseases that limit understanding of the procedures or safe participation.\n  * Significant difficulty understanding the language (spoken or written) that prevents following essential instructions or completing validated questionnaires.","ALL","18 Years",{"count":55,"type":56},26,"ESTIMATED","INTERVENTIONAL",[59],"NA","A randomized, parallel, double-blind, controlled, clinical trial. 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 cardiorespiratory variables in individuals with multiple myeloma.",[62,63,64,65,66,67],"Multiple Myeloma (MM)","Breathing Techniques","Breathing Exercises","Exercise Activity","Diaphragmatic Breathing","Heart Rate Variability (HRV)",[69,70,71,72,73,74,75],"multiple myeloma","Breathing","Diaphragmatic breathing","Slow breathing","exercise activity","Breathing exercises","heart rate variability","NOT_YET_RECRUITING","2026-01-21",{"date":79,"type":80},"2026-01-29","ACTUAL",{"date":82,"type":56},"2026-01",{"date":84,"type":56},"2026-09",{"name":5,"class":6}]