NCT07912684Recruiting
The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 28 Oct 2026
- Start date
- 10 Nov 2026
- Primary completion date
- 15 Sept 2028
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Diseases
- Multiple myeloma, Acute myeloid leukemia
- NCT number
- NCT07912684
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 10 Nov 2026 to the primary completion date, 15 Sept 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- \*\*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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia Coordinator of this site? Confirm its status | Bari | Italy | Not yet recruiting |
| Fondazione PTV - POLICLINICO TOR VERGATA Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia Coordinator of this site? Confirm its status | Verona | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.