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Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

Primary Purpose

Hematological Disease

Status

Unknown status

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Supervised exercise

About this trial

This is an interventional supportive care trial for Hematological Disease focused on measuring High-dose chemotherapy, Hematological neoplasties, Fatigue, Cancer, Exercise, Sport, Hematologic neoplastic disorders

Eligibility Criteria

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

Inclusion Criteria:

Age 18-70
Hematological disease
Treatment with high-dose chemotherapy followed by autologous stem cell transplantation
Understanding of written German

Exclusion Criteria:

Cardiorespiratory, metabolical, osteoarticular or immunological diseases 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

No Intervention

Arm Label

Supervised exercise

Control group

Arm Description

The patients will not carry out a structured exercise program.

Outcomes

Primary Outcome Measures

VO2max

Secondary Outcome Measures

Mood

Duration of aplasia

Complications during hospitalization

Need for transfusion of platelets and red blood cells

Full Information

NCT ID

NCT00883961

First Posted

April 17, 2009

Last Updated

December 21, 2009

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT00883961

Brief Title

Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study evaluates the effects of a supervised exercise program on the physical performance, the mood and the complications of therapy in patients undergoing a high-dose chemotherapy followed by an autologous peripheral blood stem cell transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematological Disease

Keywords

High-dose chemotherapy, Hematological neoplasties, Fatigue, Cancer, Exercise, Sport, Hematologic neoplastic disorders

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

No Intervention

Arm Description

The patients will not carry out a structured exercise program.

Intervention Type

Other

Intervention Name(s)

Supervised exercise

Intervention Description

The patients will carry out a daily endurance exercise program consisting of walking on a treadmill for 30 minutes at an intensity of about 80% of the maximum heart rate under supervision from study personnel.

Primary Outcome Measure Information:

Title

VO2max

Time Frame

At recruitment and after 3 weeks

Secondary Outcome Measure Information:

Title

Mood

Time Frame

At recruitment and after 3 weeks

Title

Duration of aplasia

Time Frame

3 weeks

Title

Complications during hospitalization

Time Frame

3 weeks

Title

Need for transfusion of platelets and red blood cells

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-70 Hematological disease Treatment with high-dose chemotherapy followed by autologous stem cell transplantation Understanding of written German Exclusion Criteria: Cardiorespiratory, metabolical, osteoarticular or immunological diseases 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

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

First Name & Middle Initial & Last Name & Degree

Fernando Dimeo, MD

12. IPD Sharing Statement

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Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

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