PRESENT-P: Pre-Exercise for Allogeneic Stem Cell Transplant Patients

Sponsor

University Hospital Heidelberg (Other)

Overall Status

Terminated

CT.gov ID

NCT03080792

Collaborator

University Hospital Freiburg (Other), University of Cologne (Other), University Hospital Dresden (Other)

Enrollment

Locations

Arm

30.9

Actual Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Hematological	Behavioral: Experimental: moderate to high-intensity exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Exercise

Exercise Intervention, moderate to high-intensity endurance and resistance exercise

Behavioral: Experimental: moderate to high-intensity exercise

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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) [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
Change in depression [4-12 weeks]
Center for Epidemiologic Studies Depression Scale, CES-D
Body Composition [4-12 weeks]
Bioelectrical impendance analysis
Estimate the number of eligible patients [12 month]
Evaluation of recruitment procedures [12 month]
Description of possible recruiting procedures in the ambulatory and stationary setting.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University of Colone	Cologne	Germany	50937
2	University Hospital Carl Gustav Carus Dresden	Dresden	Germany	01307
3	UCT Frankfurt / Hospital North-West	Frankfurt	Germany	60488
4	Medical Center - University Freiburg	Freiburg	Germany	79106
5	Heidelberg University Hospital	Heidelberg	Germany	69120

Sponsors and Collaborators

University Hospital Heidelberg
University Hospital Freiburg
University of Cologne
University Hospital Dresden

Investigators

Principal Investigator: Joachim Wiskemann, Dr., Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology