NCT03419988

Brief Summary

Advanced age is the main risk factor for chronic diseases such as cardiovascular disease, type 2 diabetes, Alzheimer's disease and cancer. One reason may be due to decreased resistance to oxidative stress as antioxidant defenses and cell protection is reduced with aging. This has been shown in animal studies and also that the impairment can be somewhat restored with exercise. This will be the first study to test this in humans by comparing young and older inactive adults before and after an exercise intervention, a practical and cost-effective intervention that can have tremendous public health impact by lowering risk for disease and medical-related costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

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

June 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

January 11, 2018

Last Update Submit

August 21, 2020

Conditions

Keywords

Nrf2

Outcome Measures

Primary Outcomes (2)

  • Cell signaling

    Nuclear Nrf2 protein content in peripheral mononuclear cells (PBMCs) in response to acute exercise

    8 weeks

  • Resistance to oxidative stress

    F2-isoprostane response to forearm ischemia-reperfusion

    8 weeks

Secondary Outcomes (1)

  • Cell signaling

    8 weeks

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

8-weeks exercise intervention: 3-days per week for 45-55 minutes per session

Behavioral: Exercise Intervention

Control

NO INTERVENTION

8-weeks control: asked not to change anything or start exercising.

Interventions

24 sessions of aerobic exercise

Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, 18-28 years or 60 years and older
  • Competent to independently give informed consent
  • Successful completion of screening
  • No regular exercise for the past 6-months (by self-report)
  • A score below 3.0 on the Historical Lifetime Physical Activity Questionnaire

You may not qualify if:

  • Estrogen supplementation within the previous 6 months
  • Use of anti-oxidant supplements, in excess of standard multi-vitamins (1 tablet/day)
  • Current smoker
  • Body Mass Index (BMI) ≤33 kg/m2 (Class I Obesity)
  • Any chronic illness that could affect outcome measures, including diabetes, liver or renal disease, or cancer (other than skin cancer)
  • History of a myocardial infarction within the last 6 months, clinically significant aortic stenosis, use of cardiac defibrillator, or uncontrolled angina
  • Clinically significant arrhythmia on a resting EKG or significant EKG changes during the baseline maximal oxygen consumption (VO2 max) test
  • Any other condition that would contraindicate maximal exercise testing, including elevated blood pressure at rest (systolic BP \>150 or diastolic BP \>90 mm Hg on at least 2 measurements, at least 10 minutes apart) or musculoskeletal problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

Related Publications (1)

  • Ostrom EL, Traustadottir T. Aerobic exercise training partially reverses the impairment of Nrf2 activation in older humans. Free Radic Biol Med. 2020 Nov 20;160:418-432. doi: 10.1016/j.freeradbiomed.2020.08.016. Epub 2020 Aug 28.

Study Officials

  • Tinna Traustadóttir, PhD

    Northern Arizona University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial: exercise intervention versus non-exercise control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Biological Sciences

Study Record Dates

First Submitted

January 11, 2018

First Posted

February 5, 2018

Study Start

June 1, 2017

Primary Completion

May 30, 2020

Study Completion

June 30, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations