Exercise During Chemotherapy for Patients With Hematological Malignancies

NCT00884364 | Unknown Phase 3

• 1 other identifier: EA4/031/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The trial will evaluate the effects of aerobic exercise in patients undergoing chemotherapy for the treatment of a hematological neoplastic disease.

Conditions

Hematological Diseases; Hematological Malignancies

Keywords

Lymphoma; Leukemia; Multiple myeloma; Hodgkin´s disease; Exercise; Sport; Fatigue; Hematological neoplastic diseases

Outcome Measures

Primary Outcomes (1)

• Fatigue

  At recruitment and after 12 weeks

Secondary Outcomes (2)

• Complications

  At recruitment and after 12 weeks

• Physical performance

  At recruitment and after 12 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Behavioral: Fatigue counseling

Exercise

EXPERIMENTAL

Other: Aerobic exercise

Interventions

Aerobic exercise OTHER

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.

Exercise

Fatigue counseling BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases; Hematologic Neoplasms; Lymphoma; Leukemia; Multiple Myeloma; Hodgkin Disease; Motor Activity; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fernando Dimeo, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Dimeo, MD

CONTACT

+493084452098; fernando.dimeo@charite.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 23, 2009

Record last verified: 2009-12

Locations

DE (1)