Pre-Exercise for Allogeneic Stem Cell Transplant Patients

NCT ID: NCT03080792

Last Updated: 2021-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-06-30

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.

Conditions

Cancer, Hematological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise

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

Group Type: EXPERIMENTAL

Experimental: moderate to high-intensity exercise

Intervention Type: BEHAVIORAL

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

Interventions

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)

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Freiburg

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: collaborator

University Hospital Dresden

OTHER

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Joachim Wiskemann

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim Wiskemann, Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology

Locations

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

Heidelberg University Hospital

Heidelberg, , Germany

Countries

Germany

Other Identifiers

PRESENT-P/ S-030/2016

Identifier Type: -

Identifier Source: org_study_id