NCT01783249

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

November 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
Last Updated

February 4, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

November 30, 2011

Last Update Submit

January 31, 2013

Conditions

Feasibility Pilot Study

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Control

NO INTERVENTION

Usual care monitoring

Exercise using stationary cycling

OTHER

Stationary cycling exercise program

Other: Stationary Exercise cycling

Interventions

Stationary Exercise cyclingOTHER

Stationary exercise cycling

Exercise using stationary cycling

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James P. Wilmot Cancer Center, University of Rochester

Rochester, New York, 14642, United States

Location
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2011

First Posted

February 4, 2013

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 4, 2013

Record last verified: 2013-01

Locations

US(1)