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RECRUITING

NCT07912684

The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial

Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

View on ClinicalTrials.gov

Summary

This multicenter, prospective, pilot randomized controlled trial aims to evaluate the feasibility and preliminary efficacy of a 16-week structured exercise program (SEP) in patients with hematologic malignancies, including acute myeloid leukemia, lymphoma, and multiple myeloma. A total of 75 patients will be randomized in a 1:1 ratio to either a supervised exercise intervention or a control group receiving usual care and general advice on physical activity. The intervention consists of a personalized, hybrid exercise program combining supervised home- and gym-based training, aerobic and resistance exercises, balance and stretching activities, and behavioral counseling. The primary objective is to assess the feasibility of the intervention in terms of adherence to the exercise program and patient satisfaction. Secondary objectives include evaluating intervention-related adverse events, patient-reported burden, health-related quality of life, fatigue, physical fitness, anthropometric parameters, and physical activity levels. Assessments will be conducted at baseline, approximately 8 weeks, 16 weeks (end of intervention), and 24 weeks after randomization.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11-10

Completion Date

2028-11-10

Last Updated

2026-11-03

Healthy Volunteers

Yes

Conditions

Acute Myeloid Leukemia Multiple Myeloma Lymphoma

Interventions

BEHAVIORAL

Structured Exercise Program (SEP)

A 16-week structured and supervised exercise program tailored to the individual patient's clinical condition and physical abilities. The intervention includes aerobic exercise, resistance training, balance and flexibility exercises, walking activities, and behavioral counseling. Exercise sessions may be conducted in person or at home with remote supervision, according to the patient's needs and clinical status.

Inclusion Criteria: \*\*Inclusion Criteria:\*\* 1. Patients aged between 18 and 75 years. 2. ECOG Performance Status ≤2. 3. Patients discharged after first-line intensive treatments (Category A), including: * Acute myeloid leukemia (AML) in clinical remission following first-line intensive treatment (post-consolidation), within 30 days of hospital discharge, and not candidates for transplantation. * Multiple myeloma in clinical remission following first-line treatment with autologous stem cell transplantation, within 30 days of hospital discharge. * Lymphoma in clinical remission following first-line intensive treatment (e.g., CODOX-M/IVAC, HYPER-CVAD, DA-EPOCH, CHOP/DHAP, with or without autologous stem cell transplantation consolidation), within 30 days of hospital discharge. 4. Patients receiving or having received first-line treatment in an outpatient setting (Category B), including: * Multiple myeloma in complete remission, having completed first-line treatment within the previous 30 days and undergoing maintenance therapy. * Lymphoma patients undergoing first-line treatment with at least 12 weeks of therapy remaining. 5. Written informed consent provided. \*\*Exclusion Criteria:\*\* 1. Undergoing monotherapy with monoclonal antibodies. 2. More than one line of systemic treatment. 3. Estimated life expectancy of less than 6 months. 4. Severe neurological illness. 5. Lack of cardiology clearance or left ventricular ejection fraction below 50%. 6. Unstable fractures or metastases inducing skeletal fragility, as determined by the treating hematologist, or recent femoral or vertebral fracture (within the previous 12 months). 7. Serious active infection. 8. Uncontrolled severe respiratory insufficiency or dependency on oxygen supplementation at rest or during exercise. 9. Uncontrolled severe pain. 10. Any other comorbidity contraindicating physical exercise. 11. Any circumstances preventing adherence to study requirements or the ability to provide informed consent. 12. Logistical barriers preventing adherence to the exercise program, as judged by the treating hematologist (e.g., distance from training locations, work commitments, or family circumstances). 13. Regular engagement in physical activity according to current guidelines during the previous 6 months.

Locations (3)

Fondazione PTV Policlinico Tor Vergata

Roma, Rm, Italy

Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia

Bari, Italy

Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia

Verona, Italy