NCT00884338

Brief Summary

The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.

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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 21, 2009

Status Verified

December 1, 2009

Enrollment Period

2.3 years

First QC Date

April 17, 2009

Last Update Submit

December 18, 2009

Conditions

FatigueCognitive ImpairmentStem Cell Transplantation

Keywords

FatigueCancerCognitive impairmentExerciseSportPeripheral blood stem cell transplantationHigh-dose chemotherapy

Outcome Measures

Primary Outcomes (1)

  • VO2max

    Recruitment and after 8 weeks

Secondary Outcomes (1)

  • Cognitive status, mood, quality of life

    At recruitment and after 8 weeks

Study Arms (2)

Exercise

EXPERIMENTAL
Other: Endurance exercise

Control group

ACTIVE COMPARATOR
Other: Counseling

Interventions

Endurance exerciseOTHER

The patients will carry out an endurance exercise program consisting of walking on a treadmill for 30 to 40 minutes at a speed corresponding to 80% of the maximum heart rate

Exercise
CounselingOTHER

Counseling about exercise and behavioural techniques to reduce fatigue

Control group

Eligibility Criteria

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

You may qualify if:

  • Age 18 - 70
  • Hematological neoplastic disease
  • Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years
  • Karnofsky-Index \> 80%
  • Ability to understand German

You may not qualify if:

  • Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise
  • Psychosis
  • Organic brain damage
  • Dementia
  • PBSCT in the previous 6 weeks
  • Pathological stress test at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 12200, Germany

RECRUITING

MeSH Terms

Conditions

FatigueCognitive DysfunctionNeoplasmsMotor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

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
TREATMENT
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

August 1, 2011

Study Completion

September 1, 2011

Last Updated

December 21, 2009

Record last verified: 2009-12

Locations

DE(1)