Pre-Exercise for Allogeneic Stem Cell Transplant Patients

Study Overview
=================
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.

Official Title
-----------------
Pre-Exercise for Allogeneic Stem Cell Transplant Patients: a Pilot Study

Conditions
-----------------
Cancer, Hematological

Intervention / Treatment
-----------------
* Behavioral: Experimental: moderate to high-intensity exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise Intervention, moderate to high-intensity endurance and resistance exercise | Behavioral: Experimental: moderate to high-intensity exercise<br>* 2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stem cell transplantation, exercise, high intensity interval training, resistance training, physical fitness, cancer