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Exercise During the Allogeneic Stem Cell Transplantation

Primary Purpose

Fatigue, Allogeneic Stem Cell Transplantation

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Supervised exercise
Exercise Instruction
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring Exercise, sport, Allogeneic blood stem cell transplantation, Blood stem cell transplantation, Fatigue, Cancer, Physical performance, Mood, Complications

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Neoplastic malignancy
  • Allogeneic peripheral stem cell transplantation
  • Proficiency in German

Exclusion Criteria:

  • Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise
  • Pathological stress-ECG at admission

Sites / Locations

  • Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supervised exercise

Control group

Arm Description

Outcomes

Primary Outcome Measures

VO2max

Secondary Outcome Measures

Complications
Mood
Requirement for blood and platelets transfusions

Full Information

First Posted
April 17, 2009
Last Updated
December 21, 2009
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00883714
Brief Title
Exercise During the Allogeneic Stem Cell Transplantation
Official Title
Exercise During the Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic peripheral blood stem cell transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Allogeneic Stem Cell Transplantation
Keywords
Exercise, sport, Allogeneic blood stem cell transplantation, Blood stem cell transplantation, Fatigue, Cancer, Physical performance, Mood, Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised exercise
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Supervised exercise
Intervention Description
The patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel.
Intervention Type
Other
Intervention Name(s)
Exercise Instruction
Intervention Description
The patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program.
Primary Outcome Measure Information:
Title
VO2max
Time Frame
At recruitment and after 4 weeks
Secondary Outcome Measure Information:
Title
Complications
Time Frame
4 weeks
Title
Mood
Time Frame
At recruitment and after 4 weeks
Title
Requirement for blood and platelets transfusions
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Neoplastic malignancy Allogeneic peripheral stem cell transplantation Proficiency in German Exclusion Criteria: Cardiorespiratory, metabolical, osteoarticular or immunological disorders which can be aggravated by exercise Pathological stress-ECG at admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD
Phone
+493084452098
Email
fernando.dimeo@charite.de
First Name & Middle Initial & Last Name & Degree
Fernando Dimeo, MD

12. IPD Sharing Statement

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