Influence of Exercise on Anemia in MDS Patients | NCT01783249

Studies
Influence of Exercise on Anemia in MDS Patients

NCT01783249

Sponsor

University of Rochester

Status

Withdrawn

Last Update Posted

Feb 4, 2013Estimated

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Feasibility Pilot Study

Interventions

Stationary Exercise cycling

Countries

United States

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We were unable to find patients that fit the eligibility criteria.

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2012Estimated

Completion Date

Nov 2012Actual

First Submitted Date

Nov 30, 2011

First Submission Date that Met QC Criteria

Jan 31, 2013

First Posted Date

Feb 4, 2013Estimated

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

Jan 31, 2013

Last Update Posted Date

Feb 4, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Usual care monitoring
Exercise using stationary cycling	Other	Stationary cycling exercise program	Other: Stationary Exercise cycling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stationary Exercise cycling	Other	Stationary exercise cycling	Exercise using stationary cycling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility data on the effect of a stationary cycling program	Aim to provide preliminary feasibility data on the effect of a stationary cycling program on anemia and acrocytosis, fatigue, aerobic capacity, strength, and hematopoietic stem and progenitor cell mitochondrial function in MDS patients.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:Have a confirmed diagnosis of MDS, Have approval of the study medical monitor, be able to read English, be 21 years of age or older, give informed consent -

Exclusion Criteria: Have physical limitations, be identified in the active or maintenance stage of exercise behavior

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James P. Wilmot Cancer Center, University of Rochester		Rochester	New York	14642	United States