Exercise Following Autologous Peripheral Blood Stem Cell... | NCT00883961

Studies
Exercise Following Autologous Peripheral Blood Stem Cell Transplantation

NCT00883961

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Dec 23, 2009Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Hematological Disease

Interventions

Supervised exercise

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

Dec 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 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.

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
Supervised exercise	Experimental		Other: Supervised exercise
Control group	No Intervention	The patients will not carry out a structured exercise program.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Supervised exercise	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VO2max		At recruitment and after 3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Mood		At recruitment and after 3 weeks
Duration of aplasia		3 weeks
Complications during hospitalization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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
D005221	Fatigue
D009369	Neoplasms
D009043	Motor Activity

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided