NCT07312942Toboroz
Effects of Controlled Breathing Added to Therapeutic Exercise in Multiple Myeloma
Effects of Adding a Controlled Breathing Protocol to a Therapeutic Exercise Program in Adults With Multiple Myeloma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 1.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 32 (tervezett)
- Első benyújtás
- 2025. dec. 17.
- Kezdés
- 2026. jan. 26.
- Elsődleges befejezés
- 2027. jan.
- Fő szponzor
- Universidad Complutense de Madrid
- Betegségek
- Mielóma multiplex
- NCT-szám
- NCT07312942
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 32
- 2026. jan. 26. és az elsődleges befejezés (2027. jan.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Más betegség
- 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.
Laborértékek
- 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.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hospital Universitario 12 de Octubre | Madrid | Spanyolország | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.