AgingNCT00690183
Relationship Between Physical Activity and Stem Cells in Older Adults
An observational study of Aging, run by University of Nebraska at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2008to 1 Oct 2008
- Phase
- Observational
- 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 60 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community Sample of Omaha, NE metro area
Who may be able to join
- 60 years of age or older
Who cannot join
- Hospitalization within 2 months prior
- Immunological disease
- Hematopoietic disease
- No current infection
- No current chemotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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.
- Conditions
- Aging
- Keywords
- physical activity, stem cells, lifestyle
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating stem cells
Number of circulating stem cells determined by lab
Measured: upon enrollment, one week later
physical activity
physical activity as reported
Measured: upon enrollment
Secondary outcomes (3)
alcohol consumption
alcohol consumption as reported
Measured: upon enrollment
smoking history
smoking history as reported
Measured: upon enrollment
plasma cytokine levels
plasma cytokine levels determined by lab
Measured: upon enrollment, one later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study start5 Jun 2008
- Primary completion1 Aug 2008
- Study completion1 Oct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura D Bilek, PhD, PT, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690183
- Sponsor's protocol ID
- 0226-08-EP
- Status last verified
- Sep 2023
- First submitted
- 2 Jun 2008
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Physical Activity and Stem Cells in Older Adults
- ClinicalTrials.gov ID
- NCT00690183
- Acronym / sponsor ID
- 0226-08-EP
- Conditions
- Aging
- Keywords
- physical activity, stem cells, lifestyle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 5 Jun 2008 (actual)
- Primary completion
- 1 Aug 2008 (actual)
- Study completion
- 1 Oct 2008 (actual)
- First posted
- 4 Jun 2008 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample of Omaha, NE metro area
Key inclusion criteria (1 listed)
- 60 years of age or older
Key exclusion criteria (5 listed)
- Hospitalization within 2 months prior
- Immunological disease
- Hematopoietic disease
- No current infection
- No current chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
circulating stem cells
Time frame: upon enrollment, one week later
Number of circulating stem cells determined by lab
physical activity
Time frame: upon enrollment
physical activity as reported
3 secondary outcomes
alcohol consumption
Time frame: upon enrollment
smoking history
Time frame: upon enrollment
plasma cytokine levels
Time frame: upon enrollment, one later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
Laura D Bilek, PhD, PT principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of Nebraska 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?
The sponsor lists 1 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Sep 2023. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
circulating stem cells (time frame: upon enrollment, one week later). The study lists 2 primary outcomes in all. 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 28 Sep 2023.