Clinical trial · Interventional
ENERGIA: Personalized Exercise Program for Fatigue in Patients With Myeloproliferative Neoplasms and Chronic Myeloid Leukemia
ENERGIA: Exercise in Rare Hematologic Diseases With Individualized and Adapted Management
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates whether a personalized, supervised exercise program can improve fatigue and physical function in patients with myeloproliferative neoplasms (MPN) and chronic myeloid leukemia (CML). Although many patients achieve good disease control with modern therapies, they often experience persistent symptoms such as fatigue that significantly affect daily life. Participants will take part in a 12-week exercise program that includes aerobic and resistance training, tailored to their individual fitness level and clinical condition. The program consists of two supervised sessions per week, along with additional home-based aerobic activity. Before and after the program, participants will undergo comprehensive assessments, including cardiopulmonary exercise testing, physical function tests, questionnaires on fatigue and quality of life, and blood sample collection. The study aims to determine whether this type of exercise program is feasible and safe, and whether it can reduce fatigue and improve physical capacity, quality of life, and biological markers related to inflammation and metabolism. Participants will also be followed after the intervention to evaluate whether the benefits are maintained over time.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia (CML) | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.85 |
| Myelofibrosis, Primary | Primary Myelofibrosis | ONTOLOGY_EXACT | 0.98 |
| Myeloproliferative Disease | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
| Thrombocythemia Essential | Essential Thrombocythemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Participants will take part in a 12-week exercise program that includes aerobic and resistance training, tailored to their individual fitness level and clinical condition. | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise arm
- description
- Participants will take part in a 12-week exercise program that includes aerobic and resistance training, tailored to their individual fitness level and clinical condition. Before and after the program, participants will undergo comprehensive assessments, including cardiopulmonary exercise testing, physical function tests, questionnaires on fatigue and quality of life, and blood sample collection.
- interventionNames
- Behavioral: Participants will take part in a 12-week exercise program that includes aerobic and resistance training, tailored to their individual fitness level and clinical condition.
Primary outcomes (2)
- measure
- Feasibility: Adherence to Exercise Program
- timeFrame
- Baseline to 12 weeks
- description
- Percentage of completed supervised exercise sessions relative to the total prescribed sessions over the intervention period.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Age ≥18 years Confirmed diagnosis of myeloproliferative neoplasm (polycythemia vera, essential thrombocythemia, low-risk primary myelofibrosis) or chronic myeloid leukemia according to WHO criteria Clinical and therapeutic stability for at least 8 weeks prior to enrollment Presence of clinically relevant fatigue as assessed by validated disease-specific questionnaires General clinical condition compatible with participation in a supervised exercise program of at least moderate intensity Absence of contraindications to cardiopulmonary exercise testing No participation in structured exercise or rehabilitation programs within the previous 3 months Minimum hematological safety parameters (hemoglobin \>10 g/dL; platelets \>100,000 × 10⁹/L) Ability to understand and comply with study procedures Provision of written informed consent Exclusion Criteria: Unstable cardiovascular conditions (including uncontrolled heart failure, recent myocardial ischemia, symptomatic ventricular arrhythmias, or unexplained syncope) Thrombotic or hemorrhagic events within the previous 3 months Active acute or chronic infections Severe orthopedic or neurological conditions limiting the ability to perform exercise or functional testing Severe systemic diseases (e.g., advanced renal or hepatic failure, active secondary malignancy, uncontrolled psychiatric disorders) Any clinical condition that, in the investigator's judgment, may compromise safety or adherence to the protocol Indication for a primary structured rehabilitation program based on physiatric evaluation
References
Publications (0)
Data not yet available