NCT00883961

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

April 17, 2009

Last Update Submit

December 21, 2009

Conditions

Hematological Disease

Keywords

High-dose chemotherapyHematological neoplastiesFatigueCancerExerciseSportHematologic neoplastic disorders

Outcome Measures

Primary Outcomes (1)

  • VO2max

    At recruitment and after 3 weeks

Secondary Outcomes (4)

  • Mood

    At recruitment and after 3 weeks

  • Duration of aplasia

    3 weeks

  • Complications during hospitalization

    3 weeks

  • Need for transfusion of platelets and red blood cells

    3 weeks

Study Arms (2)

Supervised exercise

EXPERIMENTAL
Other: Supervised exercise

Control group

NO INTERVENTION

The patients will not carry out a structured exercise program.

Interventions

Supervised exerciseOTHER

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.

Supervised exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

Hematologic DiseasesFatigueNeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Fernando Dimeo, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Dimeo, MD

CONTACT

+493084452098fernando.dimeo@charite.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

December 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)