NCT05156918

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

November 29, 2021

Last Update Submit

June 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Perceived stress scale survey

    Change between baseline and 30 days

  • Pittsburgh Sleep Quality Index

    Change between baseline and 30 days

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

Control group participants will make no modifications to regular diet or exercise habits for 30 days.

Other: Non Exercise

Interventions

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.

Exercise Group

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

Control Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gurinder Bains, PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor School of Allied Health

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 14, 2021

Study Start

November 29, 2021

Primary Completion

June 28, 2022

Study Completion

June 28, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations