The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial
Key facts
- Where
- Bari, Roma, and Verona, ItalySee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07912684, who can take part
Where in Italy
- Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo EmatologiaBari, ItalyNot yet recruiting
- Fondazione PTV - POLICLINICO TOR VERGATARoma, ItalyTaking people
- Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc EmatologiaVerona, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Trial code
- NCT07912684
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: **Inclusion Criteria:**; Patients aged between 18 and 75 years; ECOG Performance Status ≤2; 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; 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; Written informed consent provided; **Exclusion Criteria:**; Undergoing monotherapy with monoclonal antibodies; More than one line of systemic treatment; Estimated life expectancy of less than 6 months; Severe neurological illness; Lack of cardiology clearance or left ventricular ejection fraction below 50%; Unstable fractures or metastases inducing skeletal fragility, as determined by the treating hematologist, or recent femoral or vertebral fracture (within the previous 12 months); Serious active infection; Uncontrolled severe respiratory insufficiency or dependency on oxygen supplementation at rest or during exercise; Uncontrolled severe pain; Any other comorbidity contraindicating physical exercise; Any circumstances preventing adherence to study requirements or the ability to provide informed consent; 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); Regular engagement in physical activity according to current guidelines during the previous 6 months.