Cancer, Hematological Clinical Trial
— PRESENT-POfficial title:
Pre-Exercise for Allogeneic Stem Cell Transplant Patients: a Pilot Study
| Verified date | June 2021 |
| Source | University Hospital Heidelberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 14 |
| Est. completion date | June 2019 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University of Colone | Cologne | |
| Germany | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Heidelberg | University Hospital Dresden, University Hospital Freiburg, University of Cologne |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Secondary | Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer | 4-12 weeks | ||
| Secondary | Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT) | 4-12 weeks | ||
| Secondary | Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test | 4-12 weeks | ||
| Secondary | Change in maximal voluntary isometric hand-grip strength | 4-12 weeks | ||
| Secondary | Change in Quality of Life (QoL) | European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | 4-12 weeks | |
| Secondary | Change in Fatigue | Multidimensional Fatigue Inventory, MFI 20 | 4-12 weeks | |
| Secondary | Change in depression | Center for Epidemiologic Studies Depression Scale, CES-D | 4-12 weeks | |
| Secondary | Body Composition | Bioelectrical impendance analysis | 4-12 weeks | |
| Secondary | Estimate the number of eligible patients | 12 month | ||
| Secondary | Evaluation of recruitment procedures | Description of possible recruiting procedures in the ambulatory and stationary setting. | 12 month |