Pre-Exercise for Allogeneic Stem Cell Transplant Patients

University Hospital Heidelberg14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer, Hematological

Interventions

Experimental: moderate to high-intensity exerciseBEHAVIORAL

2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (5)

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 im Breisgau, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 4-12 weeks

Secondary Outcomes

Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer

Time frame: 4-12 weeks

Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT)

Time frame: 4-12 weeks

Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test

Time frame: 4-12 weeks

Change in maximal voluntary isometric hand-grip strength

Time frame: 4-12 weeks

Change in Quality of Life (QoL)

European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Time frame: 4-12 weeks

Change in Fatigue

Multidimensional Fatigue Inventory, MFI 20

Time frame: 4-12 weeks

Data from ClinicalTrials.gov

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