General HealthNCT06141512
Improvements in Aerobic Fitness With Exercise Training: the Role of Myokines
A study testing Reduced-exertion high-intensity interval training (REHIT) in people with General Health, run by University of Stirling at 1 site in United Kingdom.
Trial summary
For both healthy adults and patients with cardiovascular disease (CVD), aerobic fitness (V̇O2max) is a stronger predictor of the risk of future chronic disease and premature death than other established risk factors such as hypertension, smoking, or Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- General Health
- What is being tested?
- Reduced-exertion high-intensity interval training (REHIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2023to 1 Jun 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age ≥ 18 y or <40 y
- BMI < 35 kg/m2
- otherwise healthy, untrained individuals
Who cannot join
- Age <18 y or >40 y
- BMI > 35 kg/m2
- classification of 'highly physically active' according to the International Physical Activity Questionnaire (IPAQ)
- answering 'yes' to one or more questions on a standard Physical Activity Readiness Questionnaire (PAR-Q)
- resting heart rate ≥100bpm, clinically significant hypertension (140/90 mmHg)
- a personal history of metabolic or cardiovascular disease
- Female participants because of unknown effects of the menstrual cycle on the levels of the measured myokines.
Trial locations and contacts
1 site in 1 country.
About this study
For both healthy adults and patients with cardiovascular disease (CVD), aerobic fitness (V̇O2max) is a stronger predictor of the risk of future chronic disease and premature death than other established risk factors such as hypertension, smoking, or Type 2 diabetes. It is important to improve the understanding of the regulation of V̇O2max to enable optimisation of interventions aimed at increasing V̇O2max in the current predominantly sedentary population. Currently, only exercise training is a viable method for increasing V̇O2max. However, ~10-20% of people who follow fully supervised, standardised training interventions do not demonstrate a measurable increase in V̇O2max. Low response to training is a clinically relevant concern, but the large variability in response to exercise training also provides an opportunity to dissect out the molecular mechanisms responsible for adaptations to V̇O2max by contrasting low vs. high responders to training. It has been previously demonstrated that low responders for VO2max fail to up regulate a number of genes that encode putative 'myokines', while the high responders demonstrated a significant increase in the expression of these genes, suggesting these myokines may play an important mechanistic role in modulating VO2max. The aim of the present study is to examine whether low responders for VO2max have an attenuated increase in the plasma levels of the previously identified myokines.
Read the detailed description
For both healthy adults and patients with cardiovascular disease (CVD), aerobic fitness (V̇O2max) is a stronger predictor of the risk of future chronic disease and premature death than other established risk factors such as hypertension, smoking, or Type 2 diabetes. Considering the large medical and economic burden of physical inactivity-related chronic disease it is important to improve the understanding of the regulation of V̇O2max to enable optimisation of interventions aimed at increasing V̇O2max in the current predominantly sedentary population. Furthermore, there is a need to identify novel drug targets to aid pharmacological intervention in those individuals who are unwilling or unable to improve V̇O2max through exercise.
Currently, only exercise training is a viable method for increasing V̇O2max. However, although exercise training on average improves V̇O2max, ~10-20% of people who follow fully supervised, standardised training interventions do not demonstrate a measurable increase in V̇O2max. Low response to training is a clinically relevant concern, but the large variability in response to exercise training also provides an opportunity to dissect out the molecular mechanisms responsible for adaptations to V̇O2max by contrasting low vs. high responders to training.
Using this approach it has previously been shown that in skeletal muscle samples obtained pre- and post- training, 86 genes are differentially regulated in high compared to low responders for V̇O2max. Strikingly, out of these 86 genes, 13 genes encode proteins that have been reported to be released by muscle during or after exercise (i.e., 'messenger proteins' termed myokines). This strongly suggests low responders to exercise training fail to sufficiently upregulate the production and release of these myokines, and that this is (at least partly) the reason why these people do not manage to improve their V̇O2max as much as high responders. However, in order to confirm a mechanistic role of these myokines in increasing V̇O2max, it needs to be demonstrated that beside the change in gene expression, the change in the plasma levels of these myokines is also impaired in low responders for V̇O2max.
- Conditions
- General Health
- Being tested
- Reduced-exertion high-intensity interval training (REHIT)
- Keywords
- VO2max, Myokine, Cardiorespiratory Fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced-exertion high-intensity interval training (REHIT)Behavioural
Also called Sprint interval training (SIT)
Description same as Arm description.
| Study group | Role | What they receive |
|---|---|---|
| Reduced-exertion high-intensity interval training (REHIT) | Experimental | All participants complete 6 weeks (3 sessions/week) of an exercise intervention labelled 'REHIT'.
Exercise sessions involve 10 minutes of unloaded cycling interspersed with 2 x 20 sec 'all-out' sprints against a resistance of 7.5% of participant's body weight. Sprints begin at 1:40 min and 5:40 min. Receives: Behavioral: Reduced-exertion high-intensity interval training (REHIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training induced changes in VO2max
Maximal aerobic capacity (VO2max) will be measured pre- and post-training to determine the change in VO2max.
Measured: Pre-intervention and 3 days post-intervention
Training induced changes in plasma myokines
Plasma myokine levels of 8 myokines will be measured pre- and post-training to determine the change in plasma myokine levels.
Measured: Pre-intervention and 3 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start23 Oct 2023
- Primary completion30 Jun 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo the same exercise training intervention. Based on the outcome measure of VO2max, participants will be divided into groups with a low response for VO2max, a medium response, and a high response for VO2max. It will be investigated whether the change in plasma myokine levels differs between the 3 groups.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Vollaard, University of Stirling
- Investigators
- Niels Vollaard, PhD, Principal investigator, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141512
- Sponsor's protocol ID
- UStirling
- Status last verified
- Apr 2026
- First submitted
- 13 Nov 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvements in Aerobic Fitness With Exercise Training: the Role of Myokines
- ClinicalTrials.gov ID
- NCT06141512
- Acronym / sponsor ID
- UStirling
- Conditions
- General Health
- Keywords
- VO2max, Myokine, Cardiorespiratory Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For both healthy adults and patients with cardiovascular disease (CVD), aerobic fitness (V̇O2max) is a stronger predictor of the risk of future chronic disease and premature death than other established risk factors such as hypertension, smoking, or Type 2 diabetes. It is important to improve the understanding of the regulation of V̇O2max to enable optimisation of interventions aimed at increasing V̇O2max in the current predominantly sedentary population. Currently, only exercise training is a viable method for increasing V̇O2max. However, ~10-20% of people who follow fully supervised, standardised training interventions do not demonstrate a measurable increase in V̇O2max. Low response to training is a clinically relevant concern, but the large variability in response to exercise training also provides an opportunity to dissect out the molecular mechanisms responsible for adaptations to V̇O2max by contrasting low vs. high responders to training. It has been previously demonstrated that low responders for VO2max fail to up regulate a number of genes that encode putative 'myokines', while the high responders demonstrated a significant increase in the expression of these genes, suggesting these myokines may play an important mechanistic role in modulating VO2max. The aim of the present study is to examine whether low responders for VO2max have an attenuated increase in the plasma levels of the previously identified myokines.
Detailed description
For both healthy adults and patients with cardiovascular disease (CVD), aerobic fitness (V̇O2max) is a stronger predictor of the risk of future chronic disease and premature death than other established risk factors such as hypertension, smoking, or Type 2 diabetes. Considering the large medical and economic burden of physical inactivity-related chronic disease it is important to improve the understanding of the regulation of V̇O2max to enable optimisation of interventions aimed at increasing V̇O2max in the current predominantly sedentary population. Furthermore, there is a need to identify novel drug targets to aid pharmacological intervention in those individuals who are unwilling or unable to improve V̇O2max through exercise.
Currently, only exercise training is a viable method for increasing V̇O2max. However, although exercise training on average improves V̇O2max, ~10-20% of people who follow fully supervised, standardised training interventions do not demonstrate a measurable increase in V̇O2max. Low response to training is a clinically relevant concern, but the large variability in response to exercise training also provides an opportunity to dissect out the molecular mechanisms responsible for adaptations to V̇O2max by contrasting low vs. high responders to training.
Using this approach it has previously been shown that in skeletal muscle samples obtained pre- and post- training, 86 genes are differentially regulated in high compared to low responders for V̇O2max. Strikingly, out of these 86 genes, 13 genes encode proteins that have been reported to be released by muscle during or after exercise (i.e., 'messenger proteins' termed myokines). This strongly suggests low responders to exercise training fail to sufficiently upregulate the production and release of these myokines, and that this is (at least partly) the reason why these people do not manage to improve their V̇O2max as much as high responders. However, in order to confirm a mechanistic role of these myokines in increasing V̇O2max, it needs to be demonstrated that beside the change in gene expression, the change in the plasma levels of these myokines is also impaired in low responders for V̇O2max.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo the same exercise training intervention. Based on the outcome measure of VO2max, participants will be divided into groups with a low response for VO2max, a medium response, and a high response for VO2max. It will be investigated whether the change in plasma myokine levels differs between the 3 groups.
| Arm | Type | Receives |
|---|---|---|
| Reduced-exertion high-intensity interval training (REHIT) | Experimental | Behavioral: Reduced-exertion high-intensity interval training (REHIT)All participants complete 6 weeks (3 sessions/week) of an exercise intervention labelled 'REHIT'. Exercise sessions involve 10 minutes of unloaded cycling interspersed with 2 x 20 sec 'all-out' sprints against a resistance of 7.5% of participant's body weight. Sprints begin at 1:40 min and 5:40 min. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Age ≥ 18 y or <40 y
- BMI < 35 kg/m2
- otherwise healthy, untrained individuals
Key exclusion criteria (7 listed)
- Age <18 y or >40 y
- BMI > 35 kg/m2
- classification of 'highly physically active' according to the International Physical Activity Questionnaire (IPAQ)
- answering 'yes' to one or more questions on a standard Physical Activity Readiness Questionnaire (PAR-Q)
- resting heart rate ≥100bpm, clinically significant hypertension (140/90 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced-exertion high-intensity interval training (REHIT)Also: Sprint interval training (SIT)Description same as Arm description. | Behavioural | Reduced-exertion high-intensity interval training (REHIT) |
Primary outcome
Training induced changes in VO2max
Time frame: Pre-intervention and 3 days post-intervention
Maximal aerobic capacity (VO2max) will be measured pre- and post-training to determine the change in VO2max.
Training induced changes in plasma myokines
Time frame: Pre-intervention and 3 days post-intervention
Plasma myokine levels of 8 myokines will be measured pre- and post-training to determine the change in plasma myokine levels.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for General Health
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Personalize My Treatment (PMT) Registry
Cancer
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Active, not recruitingPhase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Marburg Virus Disease
Not yet recruiting
CannaRiver CBD Calm for Anxiety, Sleep, and Well-Being in Adults With Generalized Anxiety Disorder
Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Vollaard, PhD principal investigator
University of Stirling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced-exertion high-intensity interval training (REHIT) in people with General Health, run by University of Stirling at 1 site in United Kingdom.
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 4 inclusion and 7 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 29 Apr 2026. 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 United Kingdom. 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?
Training induced changes in VO2max (time frame: Pre-intervention and 3 days post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.