ENERGIA: Personalized Exercise Program for Fatigue in Patients With Myeloproliferative Neoplasms and Chronic Myeloid Leukemia

NCT07518940 | Not Yet Recruiting

• 1 other identifier: ENERGIA01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycythemia Vera; Thrombocythemia Essential; Myelofibrosis, Primary; Chronic Myeloid Leukemia (CML); Myeloproliferative Disease

Keywords

Myeloproliferative Neoplasms;; Chronic Myeloid Leukemia; Exercise Intervention; Cancer-Related Fatigue; Fatigability; Physical Activity; Cardiorespiratory Fitness; Quality of Life; physical exercise; Immunometabolism; Metabolomics; Feasibility

Outcome Measures

Primary Outcomes (2)

• Feasibility: Adherence to Exercise Program

  Percentage of completed supervised exercise sessions relative to the total prescribed sessions over the intervention period.

  Baseline to 12 weeks

• Feasibility: Retention Rate

  Proportion of participants who complete the 12-week intervention and post-intervention assessment.

  Baseline to 12 weeks

Secondary Outcomes (1)

• Safety and Tolerability

  Baseline to 12 weeks

Study Arms (1)

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.

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.

Interventions

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

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

Exercise arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmen Fava: lead
• Associazione Italiana contro Leucemie, Linfomi e Mieloma: collaborator

Study Sites (1)

AO Ordine Mauriziano di Torino

Torino, To, Italy

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Polycythemia Vera; Thrombocythemia, Essential; Primary Myelofibrosis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carmen Fava

  Department of Clinical and Biological Sciences, University of Turin, Turin, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Fava

CONTACT

00390115082224; carmen.fava@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)