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Recruitment difficult
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| Name | Class |
|---|---|
| University Hospital Freiburg | OTHER |
| University of Cologne | OTHER |
| University Hospital Dresden | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Exercise Intervention, moderate to high-intensity endurance and resistance exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: moderate to high-intensity exercise | Behavioral | 2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Adherence is defined as >50% of prescribed exercise sessions completed. | 4-12 weeks |
| Safety of supervised high-intensity exercise aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer | Minor and Major adverse events that are related to the exercise intervention | 4-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer | 4-12 weeks | |
| Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT) | 4-12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joachim Wiskemann, Dr. | Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colone | Cologne | 50937 | Germany | |||
| University Hospital Carl Gustav Carus Dresden |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test | 4-12 weeks |
| Change in maximal voluntary isometric hand-grip strength | 4-12 weeks |
| Change in Quality of Life (QoL) | European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | 4-12 weeks |
| Change in Fatigue | Multidimensional Fatigue Inventory, MFI 20 | 4-12 weeks |
| Change in depression | Center for Epidemiologic Studies Depression Scale, CES-D | 4-12 weeks |
| Body Composition | Bioelectrical impendance analysis | 4-12 weeks |
| Estimate the number of eligible patients | 12 month |
| Evaluation of recruitment procedures | Description of possible recruiting procedures in the ambulatory and stationary setting. | 12 month |
| Dresden |
| 01307 |
| Germany |
| UCT Frankfurt / Hospital North-West | Frankfurt | 60488 | Germany |
| Medical Center - University Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Heidelberg University Hospital | Heidelberg | 69120 | Germany |