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Completed

NCT Number: NCT05156918

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.

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Key information

Conditions

Exercise Behavior Motor Activity

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Any self-reported significant increase or decrease in activity levels within the past thirty days.
  • Current use of the following medications: antibiotics, glucocorticoids, anticoagulants, narcotics, antiepileptic medications, antipsychotics, antidepressants, and hypoglycemic agents.
  • Current self-reported pregnancy

Treatment and study plan

Exercise

Other

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.

Non Exercise

Other

There are no modifications to regular diet or exercise habits for 30 days.

Primary outcomes

  1. venipuncture procedure

    Time frame: Change between baseline and 30 days

    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.

Secondary outcomes

  1. Perceived stress scale survey

    Time frame: Change between baseline and 30 days

    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."

  2. Pittsburgh Sleep Quality Index

    Time frame: Change between baseline and 30 days

    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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2021
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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