Impact of Exercise Intensity on Fitness, Extracellular Vesicles, Inflammation, and Metabolism

NCT06398548 | Recruiting

• 1 other identifier: H22-02823
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction This study investigates the effects of different intensities of indoor cycling on various health measures. Participants will perform a maximal cycling test to determine their maximal fitness - a strong predictor of overall health - before and after a 6-week training intervention. Blood samples will also be obtained to look at various physiological markers related to extracellular vesicles, inflammation, and metabolism. Who can participate? Healthy young adults who between 18 and 40, are free of immune disease, with a normal body mass index can join this study. They will be divided into three groups:

• One group will ride a bike at a moderate pace.
• Another group will ride a bike at a slightly harder pace.
• The third group won't change their usual daily activities and will continue living as they normally do. What does the study involve? Each exercise session aims to burn a specific amount of calories: 350 for males and 300 for females. Participants cycle 3 times a week for 6 weeks. At the end, we'll repeat the bike test and take another blood sample to see if there have been any changes due to the exercise. Why is this research being done? The researchers want to see how different intensities of exercise impact health and fitness. This may help people make better choices about how much and what type of exercise they should do. What happens after the study? Researchers will analyze the data from the study and see if any differences exist between the protocols. If the participant is interested, we will also provide their blood test results, and the results from their max test.

Conditions

Exercise Training

Keywords

Lactate Threshold; Exercise Intensity Domain; VO2peak; Extracellular Vesicles; Mitochondrial Respiration

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake

  The peak oxygen consumption during a maximal staged exercise test

  6 Weeks

Secondary Outcomes (7)

• Extracellular Vesicle Phenotype

  6 Weeks

• Extracellular Vesicle Size and Concentration

  6 Weeks

• Extracellular Vesicle micro RNA Content

  6 Weeks

• Lactate Threshold

  6 Weeks

• Peak Power Output

  6 Weeks

Study Arms (3)

Control Group

OTHER

This group undergoes the same testing protocols as the intervention groups, but is prescribed no additional exercise.

Other: Control Group

Moderate Intensity Continuous Training

EXPERIMENTAL

In this allocation, participants cycle at 70% the resistance associated with their lactate threshold

Other: Moderate Intensity Continuous Training

Heavy Intensity Continuous Training

EXPERIMENTAL

In this allocation, participants cycle at the resistance associated with their lactate threshold, with an additional 10% of the difference between their LT and maximal achieved watts during the test.

Other: Heavy Intensity Continuous Training

Interventions

Control Group OTHER

Participants continue with their lifestyle as usual, with no modification to lifestyle, or exercise habits.

Control Group

Moderate Intensity Continuous Training OTHER

This group cycles at 70% of the resistance associated with their first lactate threshold.

Moderate Intensity Continuous Training

Heavy Intensity Continuous Training OTHER

This group cycles at 10% of the difference between the resistance associated with their lactate threshold, and maximal achieved watts, added to the resistance associated with their lactate threshold.

Heavy Intensity Continuous Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are between the ages of 18 and 40 years old.
• Have a body mass index (BMI) between 18.5 and 30 kg/m\^2.
• Perform between 60 and 200 minutes of aerobic physical activity per week.
• Do not have a history of cardiovascular disease or diabetes.

You may not qualify if:

• Require immunomodulatory medication to treat an auto-immune disease, or rely heavily on over the counter anti-inflammatory medications (e.g., Advil).
• Have a metabolic condition such as diabetes.
• Have hypertension (blood pressure \> 160/90 mmHg).
• Are uncomfortable with blood sampling.
• Are an elite endurance athlete, or training specifically for an endurance event (\>3 structured aerobic training sessions, or \>150 min of specific aerobic-based/endurance training per week).
• Adhere to an extreme diet (e.g., ketogenic diet, time restricted feeding).
• Smoke cigarettes

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

ART 115

Kelowna, British Columbia, V1V 1V7, Canada

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Jonathan P Little, PhD

CONTACT

2508079876; jonathan.little@ubc.ca

Garett S Jackson, MSc.

CONTACT

2508079122; garett.jackson@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 3 group randomized controlled trial. 1 control group, 2 exercise groups.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data may be available once the manuscript for the study has been published.

Locations

CA (1)