Exercise Training in Patients With Myeloproliferative Neoplasms

NCT07384039 | Not Yet Recruiting

• 1 other identifier: 12068-BO-S-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myeloproliferative Neoplasms (MPN)

Outcome Measures

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).

  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)

  From baseline to the end of the intervention period at 3 months

• Change in peak oxygen uptake (VO2 in ml/min/kg)

  From baseline to the end of the intervention period at 3 months

• Change in daily physical activity (MET-hours/week)

  From baseline to the end of the intervention period at 3 months

• Change in EORTC QLQ-C30 scores

  From baseline to the end of the intervention period at 3 months

• Change in the FACT-Leu Score

  From baseline to the end of the intervention period at 3 months

Other Outcomes (6)

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

  From baseline to the end of the intervention period at 3 months

• Change in steps per day

  From baseline to the end of the intervention period at 3 months

• Change in lactate dehydrogenase (LDH in U/L)

  From baseline to the end of the intervention period at 3 months

Study Arms (2)

Exercise Training Group

EXPERIMENTAL

Patients randomized to the 3-month guided exercise training program

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.

Interventions

Exercise Training BEHAVIORAL

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.

Exercise Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Uwe Tegtbur, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Haufe, Prof. Dr.

CONTACT

+49 511 532 5499; haufe.sven@mh-hannover.de

Momme Kück

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

DE (1)