The Effects of High-Intensity Exercise on Biological Age

Sponsor

Loma Linda University (Other)

Overall Status

Completed

CT.gov ID

NCT05156918

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise	Other: Exercise Other: Non Exercise	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Effects of High-Intensity Exercise on Biological Age

Actual Study Start Date :

Nov 29, 2021

Actual Primary Completion Date :

Jun 28, 2022

Actual Study Completion Date :

Jun 28, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

venipuncture procedure [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 Outcome Measures

Perceived stress scale survey [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."
Pittsburgh Sleep Quality Index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University	Loma Linda	California	United States	92350

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator: Gurinder Bains, PhD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gurinder Bains, Associate Professor School of Allied Health, Loma Linda University

ClinicalTrials.gov Identifier:

NCT05156918

Other Study ID Numbers:

5210437

First Posted:

Dec 14, 2021

Last Update Posted:

Jun 30, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 30, 2022