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Cognitive Function After Stem Cell Transplantation

Primary Purpose

Fatigue, Cognitive Impairment, Stem Cell Transplantation

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

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Fatigue, Cancer, Cognitive impairment, Exercise, Sport, Peripheral blood stem cell transplantation, High-dose chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 - 70
  • Hematological neoplastic disease
  • Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years
  • Karnofsky-Index > 80%
  • Ability to understand German

Exclusion Criteria:

  • Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise
  • Psychosis
  • Organic brain damage
  • Dementia
  • PBSCT in the previous 6 weeks
  • Pathological stress test at admission

Sites / Locations

  • Charité Universitätsmedizin BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Control group

Arm Description

Outcomes

Primary Outcome Measures

VO2max

Secondary Outcome Measures

Cognitive status, mood, quality of life

Full Information

First Posted
April 17, 2009
Last Updated
December 18, 2009
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00884338
Brief Title
Cognitive Function After Stem Cell Transplantation
Official Title
Evaluation of the Cognitive Function of Patients After 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
August 2011 (Anticipated)
Study Completion Date
September 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 trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.
Detailed Description
Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Cognitive Impairment, Stem Cell Transplantation
Keywords
Fatigue, Cancer, Cognitive impairment, Exercise, Sport, Peripheral blood stem cell transplantation, High-dose chemotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Endurance exercise
Intervention Description
The patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate
Intervention Type
Other
Intervention Name(s)
Counseling
Intervention Description
Counseling about exercise and behavioural techniques to reduce fatigue
Primary Outcome Measure Information:
Title
VO2max
Time Frame
Recruitment and after 8 weeks
Secondary Outcome Measure Information:
Title
Cognitive status, mood, quality of life
Time Frame
At recruitment and after 8 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: Age 18 - 70 Hematological neoplastic disease Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years Karnofsky-Index > 80% Ability to understand German Exclusion Criteria: Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise Psychosis Organic brain damage Dementia PBSCT in the previous 6 weeks Pathological stress test 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
Charité Universitätsmedizin Berlin
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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Cognitive Function After Stem Cell Transplantation

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