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Exercise TrainingNCT05908578

Exercise Frequency During Endurance Training: Cardiorespiratory, Hematological, and Muscle Oxidative Adaptations

A study testing High Frequency Exercise Training and Low Frequency Exercise Training in people with Exercise Training, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this interventional study is to compare training for different numbers of days each week in healthy, young individuals. The main questions it aims to answer are: Does exercising less often improve endurance fitness as much as exercising more often? Are endurance fitness improvements caused by improvements… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Exercise Training
What is being tested?
High Frequency Exercise Training and Low Frequency Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
22 May 2023to 28 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • provide written informed consent
  • complete and pass the Get Active Questionnaire (GAQ), a physical activity readiness screening tool

Who cannot join

  • classified as obese (BMI > 30 kg/m^2)
  • taking medications that are known to affect cardiovascular and/or metabolic responses to exercise (including but not limited to beta-blockers, anti-inflammatories, anti-coagulants, insulin, etc.)
  • dieting for weight loss or following a low carbohydrate diet
  • smoking or using tobacco products within the previous year
  • consuming excessive amounts of alcohol (>21 units/week)
  • having known health problems such as renal or gastrointestinal disorders, metabolic disease, heart disease, vascular disease, arthritis, diabetes, respiratory disease, uncontrolled blood pressure, dizziness, thyroid problems, or any other health conditions that may confound results
Show all 12Show fewer
  • having orthopedic issues that limit exercise performance
  • using an investigational drug product within the last 30 days
  • are pregnant
  • have donated blood in the previous 90 days
  • being highly trained or engaging in training more than 4 times per week
  • do not understand English

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Human Performance Lab, University of Calgary

    Calgary, Alberta, T2N 1N4

Other trials in Canada

About this study

The goal of this interventional study is to compare training for different numbers of days each week in healthy, young individuals. The main questions it aims to answer are:

  • Does exercising less often improve endurance fitness as much as exercising more often?
  • Are endurance fitness improvements caused by improvements in the muscle and blood?
Read more

Participants will train on a stationary bike for eight weeks. Researchers will measure the participants endurance fitness, as well as muscle and blood characteristics, before and after training to look for improvements from the training protocols.

Researchers will compare low-frequency exercise (two times per week) and high-frequency exercise (four times per week) to see if they each improve endurance fitness.

Read the detailed description

Questions and Hypotheses:

The primary research question of this study is "Does exercising less frequently lead to improvements in aerobic fitness that are not worse than the improvements from exercising more frequently, when total exercise volume and exercise intensity are matched?" The secondary research questions of this study are: "Does exercising less frequently lead to similar improvements in hemoglobin mass, neuromuscular fatigue resistance, and skeletal muscle oxidative capacity compared to exercising more frequently, when total exercise volume and exercise intensity are matched?" The investigators hypothesize that the "weekend warrior" training program will induce improvements in cardiorespiratory fitness that are not worse than the improvements elicited by the standard training protocol. The investigators hypothesize that these improvements will be driven by similar improvements in markers of skeletal muscle mitochondrial content, and hemoglobin mass, and neuromuscular fatigue resistance between both training protocols.

Study Design and Methods:

32 participants total (16 female, 16 male; 8 per sex per group) will be randomized to either the low- or high-frequency training groups and will undergo physiological testing at baseline, after 4 weeks, and after 8 weeks of training. The sample size of 32 was calculated based on an alpha of 0.05, a power of 0.90, a group allocation ratio of 1:1, and a dropout rate of 20%. As this study is using non-inferiority testing, the investigators also set the allowable difference to 0 (the null hypothesis), the standard deviation for change in the primary outcome to 3 (based on data from a recently completed study), and the non-inferiority margin to 3.5 mL/kg/min, which is equivalent to 1 metabolic equivalent of task unit (MET), a standard unit for assessing cardiorespiratory fitness that is often considered to have clinical significance.

The low- and high-frequency groups will perform exercise two or four days per week, respectively. The intensity and duration of training sessions will increase throughout the study to ensure the training stimulus is maintained as participants become fitter. Training intensities will be individualized based on exercise testing.

The investigators will measure (i) maximal oxygen uptake (V̇O2max) and ventilatory thresholds with an incremental exercise test; (ii) substrate oxidation and neuromuscular fatigue development during 30 minutes of constant work rate cycling in the heavy intensity domain, (iii) time to task failure at 80% of peak power output (i.e., "performance") following this prolonged exercise bout; (iv) hemoglobin mass with the carbon monoxide rebreathing technique; (v) non-invasive skeletal muscle oxidative capacity using near-infrared spectroscopy (NIRS). Throughout training, perceptual responses including rating of perceived exertion and rating of general fatigue will be recorded, as well as exercising heart rate and heart rate variability.

In total, participants in the high-frequency group will visit the laboratory 25 times and participants in the low-frequency group will visit the laboratory 40 times. For both groups, the total time commitment is ~37 hours spread over 12 weeks.

Training Programs:

Participants in the high-frequency and low-frequency training groups will visit the laboratory 31 and 16 times, respectively, to complete their exercise training. In total, with conservative rounding to the nearest half hour, participants will train for ~23 hours over 8 weeks.

Participants in the low-frequency group will complete 2 training sessions per week, whereas participants in the high-frequency group will complete 4 training sessions per week. To ensure that training volume is equal across groups, the low-frequency group will perform the same training sessions as the high-frequency group; however, they will perform them "back-to-back" each day. All exercise training will be based on the results of individual exercise tests.

For high-intensity interval training (HIIT), participants will perform 4 min of severe intensity exercise followed by 3 min of moderate intensity exercise. Each HIIT workout will be preceded by an 8-min warm-up. For the low-frequency group, the two HIIT workouts will be performed on the same day, but they will be interspersed by the same 8-min warm-up to ensure the total volume of exercise is equal between groups.

For the continuous training (CONT), participants will cycle at an intensity equal to ~50% of the difference between the gas exchange threshold and the respiratory compensation point. All CONT workouts will be preceded by the same 8-min warm-up. For the low-frequency group, the two CONT workouts will be performed on the same day, but they will be interspersed by the same 8-min warm-up to ensure the total volume of exercise is equal between groups.

Training load will remain constant for two weeks before either increasing in duration (week 3 and week 7) or intensity (week 5). The increase in intensity will be based on the mid-point V̇O2max test, which takes the place of 1 unit of CONT training for both groups.

Being tested
High Frequency Exercise Training, Low Frequency Exercise Training
Keywords
Exercise, Muscle, Striated, Blood, Erythrocytes, Cardiorespiratory Fitness
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Frequency Exercise TrainingOther

    Two sessions per week of high-intensity interval training (30 min each) and two sessions per week of continuous endurance exercise (30 min each). All exercise sessions will be performed on a stationary bike under supervision by an investigator.

  • Low Frequency Exercise TrainingOther

    One session per week of high-intensity interval training (60 min) and one session per week of continuous endurance exercise (60 min). All exercise sessions will be performed on a stationary bike under supervision by an investigator.

Study groups in NCT05908578
Study groupRoleWhat they receive
High-Frequency TrainingActive comparatorExercise performed on a stationary bike four times per week. Total weekly exercise volume (the product of intensity, duration, and frequency) will be matched between groups. Intensity will be the same, so the high-frequency group will perform half the duration of exercise in each session compared to the low-frequency group.
Receives: Other: High Frequency Exercise Training
Low-Frequency TrainingExperimentalExercise performed on a stationary bike two times per week. Total weekly exercise volume (the product of intensity, duration, and frequency) will be matched between groups. Intensity will be the same, so the low-frequency group will perform double the duration of exercise in each session compared to the high-frequency group.
Receives: Other: Low Frequency Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline maximal oxygen uptake (VO2max) after 8 weeks of training

    Change in maximal oxygen uptake determined using an incremental exercise test on a cycle ergometer, measured after 8 weeks of training relative to baseline

    Measured: 8 weeks

Secondary outcomes (8)
  1. Change from baseline near-infrared spectroscopy (NIRS)-derived oxidative capacity of the vastus lateralis muscle after 8 weeks of training

    Non-invasive measure of muscle ability to use oxidative phosphorylation, measured using near-infrared spectroscopy on the surface of the skin. Measure is the change from baseline after 8 weeks of training.

    Measured: 8 weeks

  2. Change from baseline hemoglobin mass after 8 weeks of training

    Total hemoglobin mass determined through dilution of carbon monoxide in the blood. Measure is the change from baseline after 8 weeks of training

    Measured: 8 weeks

  3. Change from baseline gas exchange threshold after 8 weeks of training

    Ventilatory threshold during exercise that demarcates the moderate and heavy intensity domains. Expressed in absolute terms (L/min of O2) and relative to body mass (mL/min/kg) and lean body mass (mL/min/kg). Measure is the change from baseline after 8 weeks of training.

    Measured: 8 weeks

  4. Change from baseline respiratory compensation point after 8 weeks of training

    Ventilatory threshold during exercise that demarcates the heavy and severe intensity domains. Expressed in absolute terms (L/min of O2) and relative to body mass (mL/min/kg) and lean body mass (mL/min/kg). Measure is the change from baseline after 8 weeks of training.

    Measured: 8 weeks

  5. Change from baseline peak power output after 8 weeks of training

    Maximum power output achieved during the incremental cycling test. Measure is the change from baseline after 8 weeks of training

    Measured: 8 weeks

  6. Change in time to task failure after 8 weeks of training

    Cycling time completed at 85% of peak power output during the performance test. Measure is the change from baseline after 8 weeks of training.

    Measured: 8 weeks

  7. Change in quadriceps maximal voluntary contraction (MVC) force decline in response to the same absolute exercise task, after 8 weeks of training

    Exercise induces a decrease in maximal voluntary contraction (MVC) force of the quadriceps muscle group. The decline in MVC force in response to the same absolute exercise task (i.e., the same duration and power output) will be compared to baseline after 8 weeks of training.

    Measured: 8 weeks

  8. Change in quadriceps maximal voluntary contraction (MVC) force decline in response to the same relative exercise task, after 8 weeks of training

    Exercise induces a decrease in maximal voluntary contraction (MVC) force of the quadriceps muscle group. The decline in MVC force in response to the same relative exercise task (i.e., the same duration and percentage of lactate threshold) will be compared to baseline after 8 weeks of training.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2023
  2. Study start22 May 2023
  3. Primary completion28 Jun 2024
  4. Study completion28 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will undergo the same baseline testing before being pseudo-randomly (block randomization) allocated to one of two groups, each following a different exercise training program for eight weeks.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05908578
Sponsor's protocol ID
REB23-0467
Status last verified
Jul 2024
First submitted
28 May 2023
Last updated
11 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tripp TR, Ghitter RS, Kontro H, Hargrave SJ, Gibala MJ, Aboodarda SJ, MacInnis MJ. Cardiorespiratory Fitness Improvements Following Low-Frequency Training Are Not Inferior to High-Frequency Training Matched for Intensity and Volume. Scand J Med Sci Sports. 2025 Feb;35(2):e70024. doi: 10.1111/sms.70024.

    PubMed 39921357

Questions about this trial

What is this clinical trial studying?

A study testing High Frequency Exercise Training and Low Frequency Exercise Training in people with Exercise Training, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline maximal oxygen uptake (VO2max) after 8 weeks of training (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05908578, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.

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