Exercise Training in Patients With Myeloproliferative Neoplasms
ConditionMyeloproliferative Neoplasms (MPN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHannover Medical School
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years
diagnosis of myeloproliferative neoplasia according to WHO/ICC 2022.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Exercise Training
BehavioralThe 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Exercise Training GroupExperimental treatment 1 intervention
Group B: Wait-List Control GroupNo intervention 0 interventions
Trial outcomes
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 monthsSecondary 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 months2
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 months3
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 months4
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 monthsOther 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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov