Acute Myeloid LeukemiaHematowellnessNCT07912684
The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial
A study testing Structured Exercise Program (SEP) in people with Acute Myeloid Leukemia and Multiple Myeloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia, Multiple Myeloma, Lymphoma
- What is being tested?
- Structured Exercise Program (SEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesItaly
- Study dates
- 10 Nov 2026to 10 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Not yet recruiting
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
Bari, 70126
Carla Minoia, +390805555905, carla.minoia1@gmail.com
- Recruiting
Fondazione PTV Policlinico Tor Vergata
Roma, Rm, 00133
Maria Christina Cox, +393382268017, chrisscox@gmail.com
- Not yet recruiting
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, 37134
Carlo Visco, +39045 8027488, carlo.visco@univr.it
About this study
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.
Read more
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.
- Conditions
- Acute Myeloid Leukemia, Multiple Myeloma, Lymphoma
- Being tested
- Structured Exercise Program (SEP)
- Medical subject headings
- Leukemia, Myeloid, Acute, Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Exercise Program (SEP)Behavioural
Also called upervised 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.
| Study group | Role | What they receive |
|---|---|---|
| Structured Exercise Program (SEP) | Experimental | 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. Receives: Behavioral: Structured Exercise Program (SEP) |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At 16 weeks (end of intervention)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Throughout the 16-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion10 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912684
- Sponsor's protocol ID
- GIMEMA QoL-Hematowellness
- Acronym
- Hematowellness
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT07912684
- Acronym / sponsor ID
- Hematowellness / GIMEMA QoL-Hematowellness
- Conditions
- Acute Myeloid Leukemia, Multiple Myeloma, Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 15 Sep 2028 (estimated)
- Study completion
- 10 Nov 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Exercise Program (SEP) | Experimental | Behavioral: Structured Exercise Program (SEP)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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged between 18 and 75 years.
- ECOG Performance Status ≤2.
- Patients discharged after first-line intensive treatments (Category A), including:
- Patients receiving or having received first-line treatment in an outpatient setting (Category B), including:
- Written informed consent provided.
Key exclusion criteria (13 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Exercise Program (SEP)Also: upervised 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. | Behavioural | Structured Exercise Program (SEP) |
Primary outcome
Adherence to the Structured Exercise Program
Time frame: At 16 weeks (end of intervention)
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
Patient Satisfaction With the Structured Exercise Program
Time frame: At 16 weeks (end of intervention)
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.
7 secondary outcomes
Change in Health-Related Quality of Life (EORTC QLQ-C30)
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Change in Fatigue (FACIT-Fatigue)
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Study Engagement Rate
Time frame: During the 18-month recruitment period.
Incidence of Intervention-Related Adverse Events
Time frame: Throughout the 16-week intervention period.
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)
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Non-Hematological Adverse Events
Time frame: Throughout the 16-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
Bari, Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
Verona, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Exercise Program (SEP) in people with Acute Myeloid Leukemia and Multiple Myeloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Structured Exercise Program (time frame: At 16 weeks (end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.