Pre-Exercise for Allogeneic Stem Cell Transplant Patients
- Conditions
- Cancer, Hematological
- Registration Number
- NCT03080792
- Lead Sponsor
- University Hospital Heidelberg
- Brief Summary
The PRESENT-P study is a one-arm exercise intervention study for hematological cancer patients prior allogeneic stem cell transplantation (allo-HCT). This pilot study will investigate in a prehabilitation approach the safety and feasibility of high-intensity exercise program directly prior transplantation.
- Detailed Description
The major objective of PRESENT-P is to investigate the feasibility and safety of a high intensity endurance exercise training (HIIT) and progressive resistance exercise prior allo-HCT. This multicenter pilot study will include n=30 patients. Patients perform two supervised exercise sessions per week. Recruitment take place 6-12 weeks prior allogeneic stem cell transplantation. Further aims of this pilot study are: to estimate the number of eligible patients, evaluate the recruitment procedure, and to explore the effect of HIIT prior allo-HCT on maximal oxygen uptake (VO2peak),submaximal endurance capacity, muscle strength, patient-reported-outcomes including QoL and physical functioning.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- Hematological cancer, e.g. AML, CLL, MM
- Scheduled for allo-HCT at the University Clinic Heidelberg or other cooperation sites within the next 4-12 weeks
- Patients ≥ 18 years of age
- Sufficient German language skills
- Willing/ able to train at the provided exercise facilities twice per week and to take part in the scheduled testing
- Signed informed consent
- Heart insufficiency > NYHA III or uncertain arrhythmia
- Uncontrolled hypertension
- Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl)
- Reduced standing or walking ability
- Insufficient hematological capacity (either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL)
- Any other comorbidities that preclude participation in the exercise programs
- Engaging in systematic intense exercise training (at least 1h twice per week)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety of supervised high-intensity exercise aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer 4-12 weeks Minor and Major adverse events that are related to the exercise intervention
Feasibility of supervised high-intensity aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer patients. Measured as adherence to the training protocol 4-12 weeks Adherence is defined as \>50% of prescribed exercise sessions completed.
- Secondary Outcome Measures
Name Time Method Change in maximal voluntary isometric hand-grip strength 4-12 weeks Change in Fatigue 4-12 weeks Multidimensional Fatigue Inventory, MFI 20
Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer 4-12 weeks Body Composition 4-12 weeks Bioelectrical impendance analysis
Estimate the number of eligible patients 12 month Change in Quality of Life (QoL) 4-12 weeks European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test 4-12 weeks Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT) 4-12 weeks Change in depression 4-12 weeks Center for Epidemiologic Studies Depression Scale, CES-D
Evaluation of recruitment procedures 12 month Description of possible recruiting procedures in the ambulatory and stationary setting.
Trial Locations
- Locations (5)
University Hospital Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
UCT Frankfurt / Hospital North-West
🇩🇪Frankfurt, Germany
Medical Center - University Freiburg
🇩🇪Freiburg, Germany
Heidelberg University Hospital
🇩🇪Heidelberg, Germany
University of Colone
🇩🇪Cologne, Germany