NCT00883714

Brief Summary

The study will evaluate the effects of a structured endurance exercise program on the physical performance, the mood and the complications of patients with hematological malignancies undergoing a high-dose chemotherapy followed by an allogeneic 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 May 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
11 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

Enrollment Period

1.9 years

First QC Date

April 17, 2009

Last Update Submit

December 21, 2009

Conditions

FatigueAllogeneic Stem Cell Transplantation

Keywords

ExercisesportAllogeneic blood stem cell transplantationBlood stem cell transplantationFatigueCancerPhysical performanceMoodComplications

Outcome Measures

Primary Outcomes (1)

  • VO2max

    At recruitment and after 4 weeks

Secondary Outcomes (3)

  • Complications

    4 weeks

  • Mood

    At recruitment and after 4 weeks

  • Requirement for blood and platelets transfusions

    4 weeks

Study Arms (2)

Supervised exercise

EXPERIMENTAL
Other: Supervised exercise

Control group

ACTIVE COMPARATOR
Other: Exercise Instruction

Interventions

Supervised exerciseOTHER

The patients will carry out a daily exercise program consisting of walking on a treadmill for 30 minutes at an intensity of 80% of the maximum heart rate. The patients will be supervised by medical personnel.

Supervised exercise
Exercise InstructionOTHER

The patients will receive instructions about exercise and will have access to a bike ergometer to work out. However, they will not receive daily supervision or participate in a structured exercise program.

Control group

Eligibility Criteria

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

You may qualify if:

  • Neoplastic malignancy
  • Allogeneic peripheral stem cell transplantation
  • Proficiency in German

You may not qualify if:

  • Cardiorespiratory, metabolical, osteoarticular or immunological disorders 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

FatigueMotor ActivityNeoplasms

Condition Hierarchy (Ancestors)

Signs 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

May 1, 2009

Primary Completion

April 1, 2011

Study Completion

August 1, 2011

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

DE(1)