- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00690183
Relationship Between Physical Activity and Stem Cells in Older Adults
September 25, 2023 updated by: University of Nebraska
This is a pilot study to develop a collaborative, translational research project investigating whether physical activity may in part exert a positive influence on aging via the mobilization of stem cells.
Preliminary data will be collected to explore the relationship between physical activity and stem cell populations found in the blood.
The study hypothesis is that stem cell decrease with age, but that persons who are more physically active will have a higher number of stem cells in the blood.
The first assessment will include an evaluation of health, physical activity and lifestyle via questionnaires.
Height, weight and abdominal girth will be measured, and blood will be drawn for immune and stem cell assessment.
Participants will be given a pedometer and accelerometer to wear daily for 7 days.
Participants will return for a second visit at which the pedometer and accelerometer will be returned and blood will be drawn.
Stem cell and immune assays will be repeated to evaluate the variability of these measures over time.
The correlation between stem cell numbers and physical activity will be analyzed.
Study Overview
Status
Completed
Conditions
Detailed Description
Increased numbers of circulating stem cells and physical activity are both associated with improved health in older persons.
This pilot study is the initial step in developing a collaborative, translational research project investigating whether physical activity may in part exert a positive influence on aging via the mobilization of stem cells.
The specific aim of this pilot project is to collect preliminary data to explore the relationship between physical activity and stem cell populations found in the blood and to determine the variance in the number of circulating stem cells.
We hypothesize that stem cell decrease with age, but that persons who are more physically active will have a higher number of stem cells in the blood.
A maximum of 40 persons will be recruited to participate.
Persons are eligible to participate if they are age 60 or older, haven't been hospitalized recently, do not have an immunologic or blood disease, do not have an infection, and are not undergoing chemotherapy.
Subjects will have 2 visits to the UNMC Clinical Research Center (CRC).
The first assessment will include an evaluation of health, physical activity and lifestyle via questionnaires.
Height, weight and abdominal girth will be measured, and blood will be drawn for immune and stem cell assessment.
Subjects will be given a pedometer and accelerometer to wear daily for 7 days.
Subjects will return to the CRC for a second visit at which the pedometer and accelerometer will be returned and blood will be drawn.
Stem cell and immune assays will be repeated to evaluate the variability of these measures over time.
The correlation between stem cell numbers and physical activity will be analyzed.
The data will be used to perform sample size calculations for the development of future studies.
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- University Of Nebraska Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 105 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Community Sample of Omaha, NE metro area
Description
Inclusion Criteria:
- 60 years of age or older
Exclusion Criteria:
- Hospitalization within 2 months prior
- Immunological disease
- Hematopoietic disease
- No current infection
- No current chemotherapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
circulating stem cells
Time Frame: upon enrollment, one week later
|
Number of circulating stem cells determined by lab
|
upon enrollment, one week later
|
physical activity
Time Frame: upon enrollment
|
physical activity as reported
|
upon enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
alcohol consumption
Time Frame: upon enrollment
|
alcohol consumption as reported
|
upon enrollment
|
smoking history
Time Frame: upon enrollment
|
smoking history as reported
|
upon enrollment
|
plasma cytokine levels
Time Frame: upon enrollment, one later
|
plasma cytokine levels determined by lab
|
upon enrollment, one later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura D Bilek, PhD, PT, University of Nebraska
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2008
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
June 2, 2008
First Submitted That Met QC Criteria
June 2, 2008
First Posted (Estimated)
June 4, 2008
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 25, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0226-08-EP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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