Pre-Exercise for Allogeneic Stem Cell Transplant Patients

NCT03080792 | Terminated

• 1 other identifier: PRESENT-P/ S-030/2016
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer, Hematological

Keywords

stem cell transplantation; exercise; high intensity interval training; resistance training; physical fitness; cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  4-12 weeks

Secondary Outcomes (10)

• 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

Study Arms (1)

Exercise

EXPERIMENTAL

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

Behavioral: Experimental: moderate to high-intensity exercise

Interventions

Experimental: moderate to high-intensity exercise 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)

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Heidelberg: lead
• University Hospital Freiburg: collaborator
• University of Cologne: collaborator
• University Hospital Dresden: collaborator

Study Sites (5)

University of Colone

Cologne, 50937, Germany

Location

University Hospital Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

UCT Frankfurt / Hospital North-West

Frankfurt, 60488, Germany

Location

Medical Center - University Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Heidelberg University Hospital

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Joachim Wiskemann, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: March 15, 2017
• Study Start: November 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)