Exercise During Chemotherapy for Patients With Hematologi... | NCT00884364

Studies
Exercise During Chemotherapy for Patients With Hematological Malignancies

NCT00884364

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Dec 23, 2009Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Hematological Diseases
Hematological Malignancies

Interventions

Aerobic exercise
Fatigue counseling

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Apr 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Apr 17, 2009

First Submission Date that Met QC Criteria

Apr 17, 2009

First Posted Date

Apr 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2009

Last Update Posted Date

Dec 23, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator		Behavioral: Fatigue counseling
Exercise	Experimental		Other: Aerobic exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fatigue		At recruitment and after 12 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fernando Dimeo, MD	Contact	+493084452098		fernando.dimeo@charite.de

Overall Officials

Name	Affiliation	Role
Fernando Dimeo, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30	Recruiting	Berlin	State of Berlin	12200	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006402	Hematologic Diseases
D019337	Hematologic Neoplasms
D008223	Lymphoma
D007938	Leukemia
D009101	Multiple Myeloma
D006689	Hodgkin Disease
D009043	Motor Activity
D005221	Fatigue

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases
D009371	Neoplasms by Site
D009369	Neoplasms
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided