Myeloproliferative Neoplasms (MPN)MPN-ExerciseNCT07384039
Exercise Training in Patients With Myeloproliferative Neoplasms
A study testing Exercise Training in people with Myeloproliferative Neoplasms (MPN), run by Hannover Medical School at 2 sites in Germany.
Trial summary
The investigators will investigate the response of an individualized exercise training program on quality of life, cardiorespiratory fitness and disease-specific markers in patients with myeloproliferative neoplasms (MPN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasms (MPN)
- What is being tested?
- Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesGermany
- Study dates
- 4 Feb 2026to 28 Feb 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- diagnosis of myeloproliferative neoplasia according to WHO/ICC 2022.
Who cannot join
- current participation in another intervention study
- the presence of any diseases or functional impairments that, in the opinion of the examining physician, exclude participation in a physical training intervention.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Momme Kück contact
Germany2 sites, 2 recruiting
- Not yet recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Sven Haufe, Prof. Dr., +49 511 5325499, haufe.sven@mh-hannover.de
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
0049 511 5325499, haufe.sven@mh-hannover.de
About this study
Official title: Effects of Individually Tailored Exercise on Quality of Life and Physical Performance in Patients With Myeloproliferative Neoplasms-a Randomized Controlled Study
The investigators will investigate the response of an individualized exercise training program on quality of life, cardiorespiratory fitness and disease-specific markers in patients with myeloproliferative neoplasms (MPN). To this end, the investigators will randomly assign patients with MPN to a training group and a waiting control group.
The training group will undergo an individually tailored exercise training program for three months, while the control group will maintain their usual lifestyle for three months and then has the opportunity to undergo the three-month intervention program. At the beginning and at the end of the three-month intervention phase, the investigators will evaluate physical performance, daily physical activity, muscular strength, and self-reported outcomes and compare them between the training and the control group, in order to assess potential benefits of the exercise training program.
Read the detailed description
To date, there have been no randomized intervention studies on the effects of physical training in patients with myeloproliferative neoplasms (MPN). Current leukemia and hematology society recommendations and guidelines support the engagement in regular physical activity to improve cardiovascular health, reduce fatigue, and enhance quality of life. However, no disease-specific exercise guidelines for patients with MPNs exist due to the lack of appropriate clinical trials adressing this issue. The aim of the planned study is to investigate an individually tailored physical exercise program with online monitoring for patients with MPN and to measure its effects on quality of life and physical fitness. The primary endpoint is performance (watts) at the respiratory compensation point (RCP), an established marker of submaximal physical performance.
This is a monocentric, prospective, randomized intervention study with a waiting control group. Randomization is performed in a 1:1 ratio to the study groups and is stratified for gender (male/female). The persons conducting the exercise tests (but not the trainers guiding the training program) are blinded so that there is no targeted motivation during the performance test of the intervention group.
Description of the study procedure: The intervention lasts 3 months. The waiting-control group receives the intervention after the 3-month control phase. Participants receive feedback every second week during intervention via telemonitoring or in person, depending on their distance from the study center.
The intervention includes structured, individually tailored physical training with feedback and adjustments to physical activity intensity and content. Daily activity is monitored using a wearable activity device (Garmin smartwatch). An individual training plan includes moderate endurance and strength exercises 3 times a week, with the goal of being physically active for 150 minutes per week. To avoid overexertion, training is monitored by measuring heart rate and providing individual feedback to patients.
The primary evaluation follows the intention-to-treat (ITT) principle, with missing values at the final examination replaced by the corresponding baseline values. An analysis of covariance (ANCOVA) model is used for performance at the RCP, with the mean after-before difference as the primary target variable. Covariates included in the model are the therapy group (intervention and waiting list control), the baseline values of the performance parameter, and gender (female/male). The intervention is considered successful if the lower limit of the two-sided 95% confidence interval is greater than 0.
- Conditions
- Myeloproliferative Neoplasms (MPN)
- Being tested
- Exercise Training
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingBehavioural
The intervention includes structured and tailored physical training with individual feedback and adjustments to training frequency, intensity, time and content for a total duration of 3 months. Daily activity is monitored using a wearable activity device (Vivoactive 5, Garmin, Olathe, Kansas, USA). An individual training plan includes moderate endurance and strength exercises usually 3 times a week, with the goal of being physically active for at least 150 minutes per week. Participants receive feedback at least every second week via telemonitoring or in person, depending on their distance from the study center. To avoid overexertion, training is monitored by measuring heart rate and providing individual feedback for adjustments if neccesary.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training Group | Experimental | Patients randomized to the 3-month guided exercise training program Receives: Behavioral: Exercise Training |
| Wait-List Control Group | No intervention | Patients randomized to the wait-list control group will maintain their usual lifestyle for the three months intervention period. After this period, they will have the opportunity to participate at the same intervention provided to the exercise training group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in power output (in watt) at the respiratory compensation point (RCP)
During an incremental exercise test on a bicycle ergometer power output and gas exchange will be measured continuously. Afterwards the RCP (also known as second ventilatory threshold) will be assessed based on the inflection point of the slopes of the tidal volume (VE) and the carbon dioxide output (VCO2).
Measured: From baseline to the end of the intervention period at 3 months
Secondary outcomes (5)
Change of the Myeloproliferative Neoplasm-10 (MPN-10) score by 30% (yes/no)
Evaluation of the MPN-10, a validated, patient-reported outcome questionnaire specifically designed to assess the symptoms and quality of life in patients with myeloproliferative neoplasms. MPN-10 assesses 10 key symptoms commonly experienced by MPN patients.
Scoring: 0-4 scale per item, total score ranges from 0 to 40. If the total score is reduced by 30% the binary outcome (yes/no) is fulfilled.
Measured: From baseline to the end of the intervention period at 3 months
Change in peak oxygen uptake (VO2 in ml/min/kg)
During an incremental bicycle exercise test until voluntary exhaustion gas exchange will be measured continuously breath by breath. Within the last stage, the highest oxygen uptake values from single breaths during 30 consecutive seconds are determined as the peak oxygen uptake.
Measured: From baseline to the end of the intervention period at 3 months
Change in daily physical activity (MET-hours/week)
To estimate the total and exercise-related physical activity, metabolic equivalents of task (MET) as MET-hours per week will be calculated, using the International Physical Activity Questionnaire (IPAQ-long) as self-reported outcome
Measured: From baseline to the end of the intervention period at 3 months
Change in EORTC QLQ-C30 scores
The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 is an internationally used, standardized questionnaire from the European Organization for Research and Treatment of Cancer (EORTC) that assesses health-related quality of life (HrQoL) in cancer patients, measuring functioning (physical, role, emotional, cognitive, social) and symptoms (fatigue, pain, nausea/vomiting). It uses scales from 0-100, where higher scores mean better function/HrQoL (for function scales) or worse symptoms (for symptom scales). Further, a summary score can be calculated by averaging 13 scales (after reversing symptom scales) to provide one overall measure of HrQoL, with higher scores meaning better functioning/HrQoL, and scores range from 0-100.
Measured: From baseline to the end of the intervention period at 3 months
Change in the FACT-Leu Score
The Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) is a valid measure of leukemia-specific health-related quality of life (HrQoL) for acute and chronic disease. Assessed subscales include Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and a Leukemia Subscale with overall 44 items that has to be responded on a 5 point Likert-type scale. Subscale scores and a total score with a range from 0 to 176 points are possible, with higher scores indicate better HrQoL.
Measured: From baseline to the end of the intervention period at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start4 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative Neoplasms (MPN)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uwe Tegtbur, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384039
- Sponsor's protocol ID
- 12068-BO-S-2025
- Acronym
- MPN-Exercise
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results of the publication will be available upon reasonable request.