NCT04897373

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 7, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

May 17, 2021

Last Update Submit

May 19, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline, week 12

Secondary Outcomes (4)

  • Change in Self-reported Physical Function

    Baseline, week 12

  • Change in Performance-based Physical Function

    Baseline, week 12

  • Change in Mental Function

    Baseline, week 12

  • Change in self-assessment of well-being

    Baseline, week 12

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to provide informed consent.
  • Previous participation in the AOA Program at the DAHLC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood-derived plasma and CD3+ T-cells

Study Officials

  • Nathan LeBrasseur, PhD, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 21, 2021

Study Start

August 7, 2018

Primary Completion

April 2, 2020

Study Completion

April 2, 2020

Last Updated

May 21, 2021

Record last verified: 2021-05

Locations