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Clinical Trials in Italy / NCT07518940
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ENERGIA: Personalized Exercise Program for Fatigue in Patients With Myeloproliferative Neoplasms and Chronic Myeloid Leukemia

NCT07518940 · tracked via the Priya Life Science Italy tracker
Sponsor
Carmen Fava
Phase
Not applicable
Started
2026-08-01
Last updated
2026-04-09

Condition(s) studied

Myeloproliferative DiseasePolycythemia VeraThrombocythemia EssentialMyelofibrosis, PrimaryChronic Myeloid Leukemia (CML)

Investigational drug(s) / intervention(s)

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.

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 intervention consists of a 12-week supervised program combining aerobic and resistance training, delivered twice weekly, with additional home-based aerobic activity to achieve recommended weekly exercise volumes. Exercise intensity is individualized based on baseline clinical and cardiopulmonary exercise testing parameters

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
AO Ordine Mauriziano di Torino Torino To

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07518940 on ClinicalTrials.gov ↗ ← All trials in Italy