Clinical trial NCT03080792: Pre-Exercise for Allogeneic Stem Cell Transplant Patients
Official title: Pre-Exercise for Allogeneic Stem Cell Transplant Patients: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer, Hematological
Keywords: stem cell transplantation
exercise
high intensity interval training
resistance training
physical fitness
cancer
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: University Hospital Freiburg
name: University of Cologne
name: University Hospital Dresden
First posted: 2017-03-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: 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
timeFrame: 4-12 weeks
measure: Safety of supervised high-intensity exercise aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer
timeFrame: 4-12 weeks
Secondary outcomes:
measure: Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer
timeFrame: 4-12 weeks
measure: Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT)
timeFrame: 4-12 weeks
measure: Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test
timeFrame: 4-12 weeks
measure: Change in maximal voluntary isometric hand-grip strength
timeFrame: 4-12 weeks
measure: Change in Quality of Life (QoL)
timeFrame: 4-12 weeks
measure: Change in Fatigue
timeFrame: 4-12 weeks
measure: Change in depression
timeFrame: 4-12 weeks
measure: Body Composition
timeFrame: 4-12 weeks
measure: Estimate the number of eligible patients
timeFrame: 12 month
measure: Evaluation of recruitment procedures
timeFrame: 12 month
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Colone
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Dresden
city: Frankfurt
country: Germany
facility: UCT Frankfurt / Hospital North-West
city: Freiburg
country: Germany
facility: Medical Center - University Freiburg
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
Study officials:
affiliation: Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology
name: Joachim Wiskemann, Dr.
role: PRINCIPAL_INVESTIGATOR
References: