Cancer, Hematological
Conditions
Keywords
stem cell transplantation, exercise, high intensity interval training, resistance training, physical fitness, cancer
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.
Interventions
2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training)
Sponsors
University Hospital Freiburg
University of Cologne
University Hospital Dresden
University Hospital Heidelberg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the number of eligible patients | 12 month | — |
| 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 | — |
| Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test | 4-12 weeks | — |
| Change in depression | 4-12 weeks | Center for Epidemiologic Studies Depression Scale, CES-D |
| Change in Quality of Life (QoL) | 4-12 weeks | European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30) |
| Change in Fatigue | 4-12 weeks | Multidimensional Fatigue Inventory, MFI 20 |
| Evaluation of recruitment procedures | 12 month | Description of possible recruiting procedures in the ambulatory and stationary setting. |
| Change in maximal voluntary isometric hand-grip strength | 4-12 weeks | — |
| Body Composition | 4-12 weeks | Bioelectrical impendance analysis |
Countries
Germany
Outcome results
None listed