Older AdultNCT04897373
Active Older Adult Program on Health and Well-being
An observational study of Older Adult, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a structured 12-week program designed for older adults will improve physical function and, in parallel, circulating biomarkers of aging Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Older Adult
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 2 Apr 2020
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population consists of The Dan Abraham Healthy Living Center (DAHLC) members 60 years of age and older who plan to participate in the Active Older Adult Program.
Who may be able to join
- Men and women age 55 years or older.
- Membership at the DAHLC.
- New to AOA (Active Older Adult) Program and commitment to full participation in the twelve-week program.
- Must be able to get down and off the floor with little assistance.
Who cannot join
- Inability to provide informed consent.
- Previous participation in the AOA Program at the DAHLC.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effects of an Active Older Adult Program at the Dan Abraham Healthy Living Center on Health and Well-being
The purpose of this study is to determine whether a structured 12-week program designed for older adults will improve physical function and, in parallel, circulating biomarkers of aging
- Conditions
- Older Adult
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in repeated chair rise time
Chair stand test where participants will perform a chair rise movement for five repetitions. The series of 5 repetitions will be timed and measured in seconds.
Measured: Baseline to end of study, approximately 14 weeks
Change in plasma protein levels reflective of biological age
Blood samples will be obtained at baseline and at 12 weeks. The concentration of target proteins (pg/mL) in the plasma will be measured and compared between baseline and week 12.
Measured: Baseline, week 12
Change in expression of senescence-related genes in blood cells
Blood samples will be obtained at baseline and at 12 weeks. The expression of senescence-related genes (arbitrary units) will be measured in immune cells isolated from whole blood and compared between baseline and week 12.
Measured: Baseline, week 12
Secondary outcomes (4)
Change in Self-reported Physical Function
Measured using the Physical Component Scale (PCS) from the 12-Item short form general health survey (SF-12).
Measured: Baseline, week 12
Change in Performance-based Physical Function
Measured using the timed up-and-go test (seconds to complete).
Measured: Baseline, week 12
Change in Mental Function
Measured using the Mental Component Scale (MCS) from the 12-Item short form general health survey (SF-12)
Measured: Baseline, week 12
Change in self-assessment of well-being
Measured using a linear analogue self-assessment scale of well-being from 0 ("as bad as it can be") to 10 ("as good as it can be") of mental, physical, emotional, and spiritual well-being, level of social activity, and overall quality of life during the past week
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start7 Aug 2018
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan K. LeBrasseur, Mayo Clinic
- Investigators
- Nathan LeBrasseur, PhD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897373
- Sponsor's protocol ID
- 18-001769
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 21 May 2021
- 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 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Active Older Adult Program at the Dan Abraham Healthy Living Center on Health and Well-being
- ClinicalTrials.gov ID
- NCT04897373
- Acronym / sponsor ID
- 18-001769
- Conditions
- Older Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 21 May 2021 (actual)
- 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.
The purpose of this study is to determine whether a structured 12-week program designed for older adults will improve physical function and, in parallel, circulating biomarkers of aging
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population consists of The Dan Abraham Healthy Living Center (DAHLC) members 60 years of age and older who plan to participate in the Active Older Adult Program.
Key inclusion criteria (4 listed)
- Men and women age 55 years or older.
- Membership at the DAHLC.
- New to AOA (Active Older Adult) Program and commitment to full participation in the twelve-week program.
- Must be able to get down and off the floor with little assistance.
Key exclusion criteria (2 listed)
- Inability to provide informed consent.
- Previous participation in the AOA Program at the DAHLC.
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
Change in repeated chair rise time
Time frame: Baseline to end of study, approximately 14 weeks
Chair stand test where participants will perform a chair rise movement for five repetitions. The series of 5 repetitions will be timed and measured in seconds.
Change in plasma protein levels reflective of biological age
Time frame: Baseline, week 12
Blood samples will be obtained at baseline and at 12 weeks. The concentration of target proteins (pg/mL) in the plasma will be measured and compared between baseline and week 12.
Change in expression of senescence-related genes in blood cells
Time frame: Baseline, week 12
Blood samples will be obtained at baseline and at 12 weeks. The expression of senescence-related genes (arbitrary units) will be measured in immune cells isolated from whole blood and compared between baseline and week 12.
4 secondary outcomes
Change in Self-reported Physical Function
Time frame: Baseline, week 12
Change in Performance-based Physical Function
Time frame: Baseline, week 12
Change in Mental Function
Time frame: Baseline, week 12
Change in self-assessment of well-being
Time frame: Baseline, week 12
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 21 May 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Nathan LeBrasseur, PhD, MS principal investigator
Mayo Clinic
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 Older Adult, run by Mayo Clinic 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 4 inclusion and 2 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 21 May 2021. 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?
Change in repeated chair rise time (time frame: Baseline to end of study, approximately 14 weeks). The study lists 3 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 21 May 2021.