- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897373
Active Older Adult Program on Health and Well-being
May 19, 2021 updated by: Nathan K. LeBrasseur, Mayo Clinic
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
33
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
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
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
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Inability to provide informed consent.
- Previous participation in the AOA Program at the DAHLC.
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 |
|---|---|---|
|
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.
|
Baseline to end of study, approximately 14 weeks
|
|
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.
|
Baseline, 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.
|
Baseline, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Self-reported Physical Function
Time Frame: Baseline, week 12
|
Measured using the Physical Component Scale (PCS) from the 12-Item short form general health survey (SF-12).
|
Baseline, week 12
|
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Change in Performance-based Physical Function
Time Frame: Baseline, week 12
|
Measured using the timed up-and-go test (seconds to complete).
|
Baseline, week 12
|
|
Change in Mental Function
Time Frame: Baseline, week 12
|
Measured using the Mental Component Scale (MCS) from the 12-Item short form general health survey (SF-12)
|
Baseline, week 12
|
|
Change in self-assessment of well-being
Time Frame: Baseline, week 12
|
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
|
Baseline, week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathan LeBrasseur, PhD, MS, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
August 7, 2018
Primary Completion (Actual)
April 2, 2020
Study Completion (Actual)
April 2, 2020
Study Registration Dates
First Submitted
May 17, 2021
First Submitted That Met QC Criteria
May 19, 2021
First Posted (Actual)
May 21, 2021
Study Record Updates
Last Update Posted (Actual)
May 21, 2021
Last Update Submitted That Met QC Criteria
May 19, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 18-001769
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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