An interventional study of Structured Exercise Program (SEP) in Acute Myeloid Leukemia, Multiple Myeloma and Lymphoma, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Recruiting at 3 sites in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Not applicable, Interventional, and Supportive care
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.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 75 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 135 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
**Inclusion Criteria:**
Patients discharged after intensive treatments (Category A), including:
Patients receiving or having received first-line treatment in an outpatient setting (Category B), including:
**Exclusion Criteria:**
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the intervention group will receive a 16-week personalized, supervised, hybrid structured exercise program (SEP), combining home- and gym-based training. The program includes aerobic, resistance, balance, and stretching exercises, a structured walking program, and behavioral counseling. Exercise sessions will be supervised by trained exercise professionals, either in person or remotely, according to the intervention phase.
Behavioral: Structured Exercise Program (SEP)
Participants randomized to the control group will receive usual care and general information about the benefits of physical activity. They will not participate in the supervised structured exercise program during the study period.
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.
Also known as: upervised Exercise Program (SEP)
Adherence to the Structured Exercise Program
Adherence will be assessed as the percentage of participants in the intervention group who attend at least 65% of the planned supervised exercise sessions. The intervention will be considered feasible if at least 70% of participants meet this adherence t
Time frame: At 16 weeks (end of intervention)
Patient Satisfaction With the Structured Exercise Program
Patient satisfaction will be assessed in the intervention group using the item "Overall, I am satisfied with the exercise program" from a study-specific satisfaction questionnaire. Responses are rated on a 4-point scale: "disagree", "somewhat disagree", "somewhat agree", and "agree". Satisfaction will be measured as the percentage of participants responding "somewhat agree" or "agree". The intervention will be considered feasible if at least 75% of participants meet this satisfaction criterion.
Time frame: At 16 weeks (end of intervention)
Change in Health-Related Quality of Life (EORTC QLQ-C30)
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Changes in mean scores across all questionnaire scales will be compared between and within study groups. Scores are transformed to a 0-100 scale, with higher scores indicating better functioning or global health status on functional and global health scales, and greater symptom burden on symptom scales.
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Change in Fatigue (FACIT-Fatigue)
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire. Changes in mean fatigue scores will be compared between and within study groups at baseline, 8 weeks, and 16 weeks. Fatigue will also be assessed at 24 weeks for descriptive follow-up analyses.
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Study Engagement Rate
The engagement rate will be calculated as the percentage of patients who agree to participate in the study among all patients invited to participate. Reasons for refusal will be documented to identify potential barriers to study participation.
Time frame: During the 18-month recruitment period.
Incidence of Intervention-Related Adverse Events
The number and severity of adverse events potentially related to the structured exercise program will be assessed in the intervention group. Adverse events will be monitored and recorded by exercise professionals and study personnel throughout the intervention period. Severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: Throughout the 16-week intervention period.
Patient-Reported Burden of the Intervention (FACT-G Item GP5)
Patient-Reported Burden of the Intervention (FACT-G Item GP5)
Time frame: At 8 weeks (T1) and 16 weeks (T2) after randomization.
Change in Physical Activity Levels (Godin-Shephard Questionnaire)
Changes in physical activity levels will be assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire, which evaluates the frequency of mild, moderate, and vigorous physical activity performed during leisure time. Changes will be compared between and within study groups.
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Non-Hematological Adverse Events
The prevalence of non-hematological adverse events of grade 3 or higher will be described and compared between the intervention and control groups. Adverse event severity will be classified according to CTCAE version 5.0.
Time frame: Throughout the 16-week intervention period.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gruppo Italiano Malattie EMatologiche dell'Adulto →