Exercise During Chemotherapy for Patients With Hematological Malignancies

December 21, 2009 updated by: Charite University, Berlin, Germany
The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Berlin, Germany, 12200
        • Recruiting
        • Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hematological malignant disease
  • Current chemotherapy
  • Understanding of written German

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
The patients will receive a counseling regarding the causes of fatigue, how to cope with this symptom, and general recommendations about exercise. However, they will not participate at a structured exercise program.
EXPERIMENTAL: Exercise
The patients will carry out an aerobic exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The training will be carried out three times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks
Physical performance
Time Frame: At recruitment and after 12 weeks
At recruitment and after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

September 1, 2011

Study Registration Dates

First Submitted

April 17, 2009

First Submitted That Met QC Criteria

April 17, 2009

First Posted (ESTIMATE)

April 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 21, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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