Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

NCT ID: NCT00883961

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hematological Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Supervised exercise

Group Type EXPERIMENTAL

Supervised exercise

Intervention Type OTHER

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.

Control group

The patients will not carry out a structured exercise program.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Supervised exercise

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Dept. of Sports Medicine, Charité Universitätsmedizin Berlin

Principal Investigators

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Fernando Dimeo, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Fernando Dimeo, MD

Role: CONTACT

Phone: +493084452098

Email: [email protected]

Facility Contacts

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Fernando Dimeo, MD

Role: primary

Other Identifiers

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EA4/029/09

Identifier Type: -

Identifier Source: org_study_id