The Effects of High-Intensity Exercise on Biological Age

The purpose of this graduate student research study is to determine if a high-intensity exercise program can slow or reverse biological (transcriptomic) aging and shed light on the underlying transcriptomic pathways involved.

Study Overview

• Status: Completed
• Conditions: Exercise
• Intervention / Treatment: Other: Exercise; Other: Non Exercise

Detailed Description

24 males and 24 females will be randomly assigned to either the control group or the exercise group. Baseline measures will be obtained, including questionnaires (on stress, sleep, depression, activity level, and fitness), body composition measures, vital signs, and a blood draw. Control group participants will make no modifications to regular diet or exercise habits for 30 days. Exercise group participants will perform supervised high intensity exercise three times per week at the LLU department of physical therapy laboratory utilizing treadmills, stationary bicycles, and rowing machines. Results will be collected following conclusion of the 30-day study protocol.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Sex: Both Males and Females
2. Age: 40-65 years old
3. Physical Fitness: Below average scores on the Self report fitness questionnaire
4. Physical Activity: Low as measured by the International Physical Activity Questionnaire

Exclusion Criteria:

1. Prior (within the last 5 years) or current history of cardiovascular disease, stroke, unexplained weight loss, clinical depression, congestive heart failure, cancer, arrythmia, respiratory disease, or other serious medical conditions that would make exercise unsafe or prevent full participation in the exercise protocol.
2. Any self-reported significant increase or decrease in activity levels within the past thirty days.
3. Current use of the following medications: antibiotics, glucocorticoids, anticoagulants, narcotics, antiepileptic medications, antipsychotics, antidepressants, and hypoglycemic agents.
4. Current self-reported pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; Exercise group participants will perform supervised high intensity exercise three times per week at the LLU department of physical therapy laboratory utilizing treadmills, stationary bicycles, and rowing machines.	Other: Exercise; Participants will rotate between three exercise machines (randomly assigned rotation order at outset): A Concept C2 rowing machine, a stationary bicycle, and a treadmill. Study participants will use a different machine each day so that they are using each of the three exercise machines once per week. Two treadmills, two bikes, and two rowers are available during each exercise session. Participants will be randomly assigned to one of three machine orders: treadmill-rower-bike, rower-bike-treadmill, or bike-treadmill-rower. We will employ a percent of heart rate protocol as an exercise intensity measure (77-93% of age-adjusted maximum heart rate) rather than a less well-defined maximal effort protocol or rating of perceived exertion scale. For the purposes of this exercise protocol high intensity exercise will be defined as 77-93% of age adjusted maximum heart rate.
Active Comparator: Control Group; Control group participants will make no modifications to regular diet or exercise habits for 30 days.	Other: Non Exercise; There are no modifications to regular diet or exercise habits for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
venipuncture procedure	Participants will have 8ml of blood drawn on two separate occasions by a certified phlebotomist. The first 8 ml (1.62tsp) blood draw will occur at 8am on day 1 of the study protocol. The second 8ml (1.62tsp) blood draw will occur approximately 30 days later. The total blood draw volume will be 16ml or approximately 3.25 teaspoons. The blood draw is to test for the effects of exercise on gene expression and aging.	Change between baseline and 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived stress scale survey	The most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are regarded as stressful during the past 30 days. Responses are scored from 0 to 4. And the total score can be from 0 to 40. "Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress."	Change between baseline and 30 days
Pittsburgh Sleep Quality Index	A self-rated questionnaire which assesses sleep quality over a 1-month period. Questions are scored between a zero and three. A total score of 5 or greater means poor sleep quality.	Change between baseline and 30 days

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Gurinder Bains, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): June 28, 2022
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 5210437

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No