ClinicalTrials.gg
RecruitingNCT07384039MPN-ExerciseUpdated Aug 14, 2026

Exercise Training in Patients With Myeloproliferative Neoplasms

An interventional study of Exercise Training in Myeloproliferative Neoplasms (MPN), sponsored by Hannover Medical School. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Hannover Medical School · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 54 studies in Myeloproliferative Disorders with a site in Germany — 7 open to participants now, 18 under way, 5 of them phase 3. Myeloproliferative Disorders · Germany.

Planned enrollment
37th of 48
80 · median 166
Started
2026
with 1 other
No phase
3 of 54
1 open now
Primary completion
2026-12
later than 7 of 17 live
Registered
53rd of 54
by date

Among the 54 studies in Myeloproliferative Disorders with a site in Germany, this one is the 37th largest by planned enrollment of the 48 interventional ones that give a count, is one of 2 that started in 2026, is one of 3 with no phase, reaches primary completion later than 7 of the 17 other live ones, and was the 53rd registered.

Myeloproliferative Disorders

667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.

Browse Myeloproliferative Disorders studies →

Open to participants now

7 of the 54 studies in Myeloproliferative Disorders with a site in Germany are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 87 Myeloproliferative Disorders studies recruiting now, 63 (72%) set no upper age limit and 18 (21%) stop at 75 or younger; 22 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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). 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.

03

Conditions studied

  • Myeloproliferative Neoplasms (MPN)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age ≥ 18 years
  • diagnosis of myeloproliferative neoplasia according to WHO/ICC 2022.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Exercise Training Group

    Patients randomized to the 3-month guided exercise training program

    Behavioral: Exercise Training

  • No intervention
    Wait-List Control Group

    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.

Interventions

  • BehavioralExercise Training

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: From baseline to the end of the intervention period at 3 months

Secondary outcomes

  1. 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.

    Time frame: From baseline to the end of the intervention period at 3 months

  2. 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.

    Time frame: From baseline to the end of the intervention period at 3 months

  3. 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

    Time frame: From baseline to the end of the intervention period at 3 months

  4. 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.

    Time frame: From baseline to the end of the intervention period at 3 months

  5. 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.

    Time frame: From baseline to the end of the intervention period at 3 months

Other outcomes

  1. Change in power output (in watt) at the Ventilatory Threshold (VT)

    During the incremental exercise test on a bicycle ergometer power output and gas exchange will be measured continuously. Afterwards the VT will be assessed based on the inflection point of the slopes of the carbon dioxide output (VCO2) and the ventilated oxygen (VO2).

    Time frame: From baseline to the end of the intervention period at 3 months

  2. Change in steps per day

    Number of steps will be recorded by a wearable activity tracker (Vivoactive 5, Garmin, Olathe, Kansas, USA) during 7 consecutive days. Valid days will be averaged to get the outcome steps/day.

    Time frame: From baseline to the end of the intervention period at 3 months

  3. Change in lactate dehydrogenase (LDH in U/L)

    LDH is released into the bloodstream upon cellular damage or increased turnover. In patients with MPNs, elevated LDH levels are commonly observed and are associated with increased disease burden, tumor cell proliferation, and adverse prognosis. LDH serves as a non-specific but clinically useful biomarker of disease activity and metabolic stress.

    Time frame: From baseline to the end of the intervention period at 3 months

  4. Change in platelet count (in Tsd./µl )

    Platelet count is a key component of the complete blood count and reflects bone marrow activity and hemostatic function. In MPNs abnormal platelet production is a hallmark feature, often leading to sustained thrombocytosis (elevated platelet count). Elevated platelet counts are associated with increased risk of thrombotic and hemorrhagic complications, which are major clinical concerns in MPN management.

    Time frame: From baseline to the end of the intervention period at 3 months

  5. Change in growth differentiation factor 15 (GDF15 in ng/l)

    GDF15 is produced by a variety of tissues in response to cellular stress, inflammation, oxidative damage, and mitochondrial dysfunction. Elevated serum GDF15 levels are associated with aging, chronic inflammation, and several hematologic and malignant conditions. In MPNs, GDF15 is often upregulated due to increased bone marrow stress, dysregulated hematopoiesis, and systemic inflammation. Higher GDF15 levels correlate with disease burden, symptom burden, and adverse outcomes, making it a potential biomarker of disease activity and systemic stress.

    Time frame: From baseline to the end of the intervention period at 3 months

  6. Change in soluble interleukin-2 receptor (sIL-2R in KU/l)

    SIL-2R serves as a biomarker of immune system activation and lymphocyte proliferation. Elevated serum levels of sIL-2R are associated with chronic inflammation, autoimmune disorders, and hematologic malignancies. In MPNs, persistent immune dysregulation and chronic inflammation contribute to disease pathogenesis and symptom burden, and sIL-2R levels often correlate with disease activity, inflammatory burden, and clinical progression.

    Time frame: From baseline to the end of the intervention period at 3 months

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data that underlie the results of the publication will be available upon reasonable request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: beginning 6 months after publication and ending 5 years after publication.

Access criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to sportmedizin@mh-hannover.de to gain access, data requestors will need to sign a data-use agreement.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.

Of 26 interventional studies with no phase under Myeloproliferative Disorders, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 128. This study's planned 10 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2026
First posted
Feb 3, 2026
StartActual
Feb 4, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Feb 28, 2027
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07384039
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Feb 4, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Aug 14, 2026

Study contacts

Sven Haufe, Prof. Dr.
Contact
haufe.sven@mh-hannover.de
+49 511 532 5499
Momme Kück
Contact
Uwe Tegtbur, Prof. Dr.
principal investigator · Hannover Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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