Bewegung & Krebs

PRESENT-P Study

Pre-Exercise for allogeneic stem cell transplant patients: a pilot study

Principal investigator:
PD Dr. Joachim Wiskemann

Co-Principal investigator:
Dr. Rea Kühl

Abstract

An allogeneic stem cell transplantation (allo-HCT) is an intensive treatment for hematological malignancies and associated with a variety of therapy related side-effects as well as marked reductions in physical performance. A growing body of evidence suggests that exercise interventions during and/or after allogeneic stem cell transplantation are safe and beneficial. Positive effects range from improved physical performance e.g. endurance capacity and muscle strength, to psychosocial effects, e.g. improved fatigue, subsequently resulting in enhanced quality of life (QOL).

However, no study in the hematological setting proofed a concept of prehabilitation. Nevertheless, there are first studies demonstrating that objectively measured physical performance prior allo-HCT is a predictor for overall survival and non-relapse mortality, indicating the importance of good physical fitness prior allo-HCT. The concept of prehabilitation has been already examined in pre-surgical settings, mostly in lung cancer patients. To proof the concept of prehabilitation in allo-HCT, we aim to conduct a pilot study (PRESENT-P) first, for a subsequently planned multicenter randomized phase III clinical trial (PRESENT).

The major objectives of PRESENT-P are (1) to investigate the feasibility and safety of a high-intensity endurance exercise training (HIIT) and resistance exercise prior allo-HCT; (2) to estimate the number of eligible patients, evaluate the recruitment procedure and reasons for non-participation; and (3) to explore the effect of HIIT prior allo-HCT on maximal oxygen uptake (VO2peak) and submaximal endurance capacity, muscle strength, tolerability and adherence to the exercise program, patient-reported-outcomes including QoL and physical functioning.

The PRESENT study is planned to be a multicenter randomized controlled trial comparing supervised high-intensity interval endurance training and resistance training (HIIT) vs home-based moderate exercise (endurance and resistance training, ME). Within the pilot study (PRESENT-P) we aim to investigate the feasibility of the recruitment procedure and the safety of HIIT since we already proved feasibility of training in a home-based ME setting. The PRESENT-P study will be performed with n=30 hematological cancer patients prior allo-HCT at the University Hospital Heidelberg and other German cooperation sites (Freiburg, Dresden). Patients will start the exercise intervention 4-8 weeks prior to allo-HCT until day of admission. Before intervention starts and at the day of admission VO2peak, submaximal endurance capacity, muscle strength, and patient reported outcomes will be assessed.

Current status

Recruitment for the PRESENT-P-Study started in November 2016.

ClinicalTrials.gov registration (NCT03080792)

Contact

Dr. Rea Kühl
Phone: +49 6221 56-36180
E-mail: rea.kuehl@nct-heidelberg.de