Myeloproliferative DiseaseENERGIANCT07518940
ENERGIA: Personalized Exercise Program for Fatigue in Patients With Myeloproliferative Neoplasms and Chronic Myeloid Leukemia
A study testing 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 people with Myeloproliferative Disease and Polycythemia Vera, run by Carmen Fava at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disease, Polycythemia Vera, Thrombocythemia Essential
- What is being tested?
- 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.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
AO Ordine Mauriziano di Torino
Torino, To
Carmen Fava, 00390115082224, carmen.fava@unito.it
About this study
Official title: ENERGIA: Exercise in Rare Hematologic Diseases With Individualized and Adapted Management
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.
Read the detailed description
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.
- Conditions
- Myeloproliferative Disease, Polycythemia Vera, Thrombocythemia Essential, Myelofibrosis, Primary, Chronic Myeloid Leukemia (CML)
- Being tested
- 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.
- Keywords
- Myeloproliferative Neoplasms;, Chronic Myeloid Leukemia, Exercise Intervention, Cancer-Related Fatigue, Fatigability, Physical Activity, Cardiorespiratory Fitness, Quality of Life, physical exercise, Immunometabolism, Metabolomics, Feasibility
- Medical subject headings
- Myeloproliferative Disorders, Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Behavioural
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 group | Role | What they receive |
|---|---|---|
| Exercise arm | Experimental | 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Adherence to Exercise Program
Percentage of completed supervised exercise sessions relative to the total prescribed sessions over the intervention period.
Measured: Baseline to 12 weeks
Feasibility: Retention Rate
Proportion of participants who complete the 12-week intervention and post-intervention assessment.
Measured: Baseline to 12 weeks
Secondary outcomes (1)
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.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmen Fava
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana contro Leucemie, Linfomi e Mieloma
- Responsible party
- Sponsor-investigator, Carmen Fava, University of Turin, Italy
- Investigators
- Carmen Fava, Principal investigator, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518940
- Sponsor's protocol ID
- ENERGIA01
- Acronym
- ENERGIA
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENERGIA: Exercise in Rare Hematologic Diseases With Individualized and Adapted Management
- ClinicalTrials.gov ID
- NCT07518940
- Acronym / sponsor ID
- ENERGIA / ENERGIA01
- Conditions
- Myeloproliferative Disease, Polycythemia Vera, Thrombocythemia Essential, Myelofibrosis, Primary, Chronic Myeloid Leukemia (CML)
- Keywords
- Myeloproliferative Neoplasms;, Chronic Myeloid Leukemia, Exercise Intervention, Cancer-Related Fatigue, Fatigability, Physical Activity, Cardiorespiratory Fitness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Carmen FavaUniversity, hospital or other
- Collaborators
- Associazione Italiana contro Leucemie, Linfomi e Mieloma
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise arm | Experimental | 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.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Exercise arm |
Primary outcome
Feasibility: Adherence to Exercise Program
Time frame: Baseline to 12 weeks
Percentage of completed supervised exercise sessions relative to the total prescribed sessions over the intervention period.
Feasibility: Retention Rate
Time frame: Baseline to 12 weeks
Proportion of participants who complete the 12-week intervention and post-intervention assessment.
1 secondary outcome
Safety and Tolerability
Time frame: Baseline to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen Fava principal investigator
Department of Clinical and Biological Sciences, University of Turin, Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Myeloproliferative Disease and Polycythemia Vera, run by Carmen Fava at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen Fava (00390115082224, carmen.fava@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Adherence to Exercise Program (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.