Feasibility Pilot StudyPhase 1/2NCT01783249
Influence of Exercise on Anemia in MDS Patients
A Phase 1/2 study testing Stationary Exercise cycling in people with Feasibility Pilot Study, run by University of Rochester at 1 site in United States.
Trial summary
That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Feasibility Pilot Study
- What is being tested?
- Stationary Exercise cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
-
Trial locations and contacts
1 site in 1 country.
United States1 site
James P. Wilmot Cancer Center, University of Rochester
Rochester, New York, 14642
About this study
Official title: The Influence of Exercise on Anemia in MDS Patients
That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function.
- Conditions
- Feasibility Pilot Study
- Being tested
- Stationary Exercise cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stationary Exercise cyclingOther
Stationary exercise cycling
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care monitoring |
| Exercise using stationary cycling | Other | Stationary cycling exercise program Receives: Other: Stationary Exercise cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startNov 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012
Why it stopped: We were unable to find patients that fit the eligibility criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility Pilot StudyStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783249
- Sponsor's protocol ID
- 37173MDS
- Status last verified
- Jan 2013
- First submitted
- 30 Nov 2011
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Exercise on Anemia in MDS Patients
- ClinicalTrials.gov ID
- NCT01783249
- Acronym / sponsor ID
- 37173MDS
- Conditions
- Feasibility Pilot Study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to find patients that fit the eligibility criteria.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
That exercise will reduce anemia and fatigue, while improving aerobic capacity, strength and hematopoietic stem and progenitor cell mitochondrial function.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care monitoring |
| Exercise using stationary cycling | Other | Other: Stationary Exercise cyclingStationary cycling exercise program |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stationary Exercise cyclingStationary exercise cycling | Other | Exercise using stationary cycling |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stationary Exercise cycling in people with Feasibility Pilot Study, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility data on the effect of a stationary cycling program. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.