An interventional study of 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. in Myeloproliferative Disease, Polycythemia Vera and Thrombocythemia Essential, sponsored by Carmen Fava. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Carmen Fava · Not applicable, Interventional, and Treatment
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.
Myeloproliferative neoplasms (MPN), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, as well as chronic myeloid leukemia (CML), are chronic hematologic conditions characterized by prolonged survival but a substantial and persistent symptom burden. Among these, fatigue represents one of the most prevalent and disabling symptoms, often persisting despite optimal disease control. Its pathophysiology is multifactorial and involves chronic low-grade inflammation, immune dysregulation, neuroendocrine alterations, impaired mitochondrial function, and reduced physical capacity.
Exercise has emerged as a promising non-pharmacological intervention capable of targeting several of these mechanisms simultaneously. Acute and chronic exercise are known to modulate inflammatory pathways, improve mitochondrial efficiency, enhance autonomic regulation, and increase cardiorespiratory fitness and muscle strength. These adaptations are biologically plausible mediators of improvements in fatigue and overall functional status. However, evidence specifically addressing patients with MPN and CML remains limited, and data on feasibility, safety, and mechanistic responses are still scarce.
This study is a prospective, single-arm, interventional trial designed to evaluate the feasibility, safety, and preliminary efficacy of a structured, personalized exercise program in patients with MPN and CML. 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.
Participants will undergo a comprehensive multidimensional assessment at baseline (T0), after the intervention (T1), and at follow-up (T2). Outcomes include feasibility measures (adherence and retention), safety (adverse events), and clinical endpoints such as fatigue, fatigability, cardiorespiratory fitness, physical function, body composition, cardiovascular risk profile, and psychosocial well-being. In addition, the study includes exploratory analyses of immunometabolic responses, integrating metabolomic and inflammatory biomarker profiling to investigate potential biological mechanisms underlying clinical changes.
The results of this study are expected to provide clinically relevant data on the implementation of exercise as a supportive therapy in patients with chronic hematologic malignancies and to inform the design of future controlled trials.
667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.
This study's planned enrollment of 25 is below the median of 47 across 462 interventional studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders studies →Carmen Fava is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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 to cardiopulmonary exercise testing No participation in structured exercise or rehabilitation programs within the previous 3 months Minimum hematological safety parameters ( >10 g/dL; >100,000 × 10⁹/L) Ability to understand and comply with study procedures Provision of written
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 , 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Feasibility: Adherence to Exercise Program
Percentage of completed supervised exercise sessions relative to the total prescribed sessions over the intervention period.
Time frame: Baseline to 12 weeks
Feasibility: Retention Rate
Proportion of participants who complete the 12-week intervention and post-intervention assessment.
Time frame: Baseline to 12 weeks
Safety and Tolerability
Incidence and type of adverse events related to exercise, including musculoskeletal injuries, cardiovascular events, and clinical complications temporally associated with the intervention.
Time frame: Baseline to 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Sep 2027, 13 months later.
Of 26 interventional studies with no phase under Myeloproliferative Disorders, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 128. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Carmen Fava