Effects of Adding a Controlled Breathing Protocol to a Therapeutic Exercise Program in Adults With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Somatic Symptom Questionnaire
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Only the principal investigator will have access to the randomization sequence, thereby maintaining blinding for the rest of the team involved in data collection.
Both groups will receive the same therapeutic exercise program and an educational session with a standardized educational leaflet on the importance of physical activity and proper breathing in daily life, with the aim of minimizing differences in the perceived intervention.
The study will include evaluator blinding, as all assessments will be carried out by an independent investigator who is not involved in the randomization process and is unaware of participants' group allocation. Additionally, statistical analyses will be conducted by a specialized statistician, also blinded to group assignment, thereby ensuring impartiality in the analysis and interpretation of the results.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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: 2.
- •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: 3.
- •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: 4.
- •Inability to remain in the supine position for ≥ 5 minutes, required for part of the breathing intervention.
- •Confirmed pregnancy or reasonable suspicion of pregnancy. 4.
- •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.
结局指标
主要结局
Somatic Symptom Questionnaire
时间窗: 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
次要结局
- Global quality of life(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(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(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.)
研究者
Isidro Fernández López
PT, PhD.
Universidad Complutense de Madrid