Cognitive Function After Stem Cell Transplantation | NCT00884338

Studies
Cognitive Function After Stem Cell Transplantation

NCT00884338

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Dec 21, 2009Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Fatigue
Cognitive Impairment
Stem Cell Transplantation

Interventions

Endurance exercise
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

Aug 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 18, 2009

Last Update Posted Date

Dec 21, 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 an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.

Detailed Description

Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.

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
Exercise	Experimental		Other: Endurance exercise
Control group	Active Comparator		Other: Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endurance exercise	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VO2max		Recruitment and after 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cognitive status, mood, quality of life		At recruitment and after 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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
Charité Universitätsmedizin Berlin	Recruiting	Berlin	State of Berlin	12200	Germany

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue
D060825	Cognitive Dysfunction
D009369	Neoplasms
D009043	Motor Activity

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D003072	Cognition Disorders
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003376	Counseling

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided