Mental Health Wellness 1NCT06069427
The Effect of Reducing Total Volume of Sprint Exercise on Circulating Levels of BDNF
A study testing Sprint interval training (SIT) and Reduced-exertion high-intensity interval training (REHIT in people with Mental Health Wellness 1, run by University of Stirling at 1 site in United Kingdom.
Trial summary
Regular exercise is well known to be required for good physical health, but exercise can also improve mental health. Although the effects of exercise on mental health have been shown in many studies, it remains unclear how exercise improves mental health. 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
- Mental Health Wellness 1
- What is being tested?
- Sprint interval training (SIT) and Reduced-exertion high-intensity interval training (REHIT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2023to 31 Dec 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently health young male volunteers
Who cannot join
- Age <18 y or >40 y
- BMI > 35 kg/m2
- participation in a structured exercise training programme at any time in the preceding 6 months
- suffering from acute (e.g., common cold, Covid-19, flu, etc) or chronic disease (e.g., diabetes, heart disease, cancer, etc)
- answering 'yes' to one or more questions of a standard physical activity readiness questionnaire (PAR-Q)
- resting heart rate ≥100 bpm
- clinically significant hypertension (>140/90 mm Hg)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Stirling
Stirling, Midlothian, FK9 4LA
About this study
Official title: The Effect of Reducing Total Volume of Sprint Exercise in Sprint Interval Training Protocols on Circulating Levels of Brain-derived Neurotrophic Factor (BDNF)
Regular exercise is well known to be required for good physical health, but exercise can also improve mental health. Although the effects of exercise on mental health have been shown in many studies, it remains unclear how exercise improves mental health. In recent years, the potential role of a specific protein called 'brain-derived neurotrophic factor' (BDNF) has received increasing attention. Higher levels of BDNF in the blood are associated with better cognitive performance, attention, and spatial memory. Conversely, low levels of BDNF in the blood are found in patients with depression, dementia, mild cognitive impairment, and Alzheimer's disease. BDNF can be released during exercise, with greater increases after exercise performed at higher intensities. For example, classic sprint interval training (SIT), which involves four 30-second 'all-out' cycle sprints, has been shown to lead to greater increases in BDNF compared to moderate or vigorous exercise. Although these results suggest that SIT is an effective way to increase BDNF, SIT is not generally considered feasible for patients or untrained members of the general public, because it is a very tiring type of exercise. However, other more manageable protocols have been developed, such as the 'reduced-exertion, high-intensity interval training' (REHIT) protocol, which involves two 20-second 'all-out' sprints within a 10-minute low-intensity exercise session. Although it is clear that BDNF levels increase in an intensity-dependent manner in response to exercise, the effect of exercise volume remains unknown. Exercise intensity is identical for SIT and REHIT, but if BDNF levels increase to a similar extent in response to both protocols, REHIT would constitute a more feasible intervention for use in patients and the general public. The aim of the present study is to compare the effects of REHIT vs. classic SIT on levels of BDNF in the blood. For this,15 study participants will be recruited, who will each complete a SIT session, a REHIT session, and a no-exercise control session. Levels of BDNF will be measured in blood samples taken at rest, as well as directly after exercise, 30 minutes after exercise, and 90 minutes after exercise. It will be determined whether the greater amount of sprint exercise in a SIT session will be associated with a greater increase in levels of BDNF in the blood compared to the REHIT session which consists of a lower amount of sprint exercise.
- Conditions
- Mental Health Wellness 1
- Being tested
- Sprint interval training (SIT), Reduced-exertion high-intensity interval training (REHIT, No-exercise control (CON)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprint interval training (SIT)Behavioural
The SIT protocol consists of 4 repeated 30-second, 'all-out' cycle sprints against a resistance equivalent to 7.5% of body mass on a stationary bicycle. The first sprint will be preceded by a 4-minute warm-up consisting of unloaded pedalling. Each sprint will be followed by 4 minutes of unloaded pedalling.
Reduced-exertion high-intensity interval training (REHITBehavioural
The REHIT protocol consists of 2 repeated 20-second, 'all-out' cycle sprints against a resistance equivalent to 7.5% of body mass on a stationary bicycle. The first sprint will be preceded by a 2-minute warm-up consisting of unloaded pedalling. The first sprint will be followed by 3 minutes of unloaded pedalling, and the second sprint will be followed by 4 minutes of unloaded pedalling.
No-exercise control (CON)Behavioural
The control condition will involve seated rest for a period equivalent to the other interventions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of BDNF
Plasma levels of the protein brain-derived neurotrophic factor (BDNF) will be measured pre-exercise, directly post-exercise, and 30 and 90 minutes post-exercise. The area-under-the-curve for plasma BDNF will be calculated. Differences in AUC between the 3 trails will be determined.
Measured: Pre-exercise, directly post-exercise, and 30 and 90 minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start15 Nov 2023
- Primary completion30 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Participants will each undergo 3 trials in a randomised order.
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT06069427
- Sponsor's protocol ID
- 14395
- Status last verified
- Mar 2025
- First submitted
- 27 Sep 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reducing Total Volume of Sprint Exercise in Sprint Interval Training Protocols on Circulating Levels of Brain-derived Neurotrophic Factor (BDNF)
- ClinicalTrials.gov ID
- NCT06069427
- Acronym / sponsor ID
- 14395
- Conditions
- Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 5 Oct 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.
Regular exercise is well known to be required for good physical health, but exercise can also improve mental health. Although the effects of exercise on mental health have been shown in many studies, it remains unclear how exercise improves mental health. In recent years, the potential role of a specific protein called 'brain-derived neurotrophic factor' (BDNF) has received increasing attention. Higher levels of BDNF in the blood are associated with better cognitive performance, attention, and spatial memory. Conversely, low levels of BDNF in the blood are found in patients with depression, dementia, mild cognitive impairment, and Alzheimer's disease. BDNF can be released during exercise, with greater increases after exercise performed at higher intensities. For example, classic sprint interval training (SIT), which involves four 30-second 'all-out' cycle sprints, has been shown to lead to greater increases in BDNF compared to moderate or vigorous exercise. Although these results suggest that SIT is an effective way to increase BDNF, SIT is not generally considered feasible for patients or untrained members of the general public, because it is a very tiring type of exercise. However, other more manageable protocols have been developed, such as the 'reduced-exertion, high-intensity interval training' (REHIT) protocol, which involves two 20-second 'all-out' sprints within a 10-minute low-intensity exercise session. Although it is clear that BDNF levels increase in an intensity-dependent manner in response to exercise, the effect of exercise volume remains unknown. Exercise intensity is identical for SIT and REHIT, but if BDNF levels increase to a similar extent in response to both protocols, REHIT would constitute a more feasible intervention for use in patients and the general public. The aim of the present study is to compare the effects of REHIT vs. classic SIT on levels of BDNF in the blood. For this,15 study participants will be recruited, who will each complete a SIT session, a REHIT session, and a no-exercise control session. Levels of BDNF will be measured in blood samples taken at rest, as well as directly after exercise, 30 minutes after exercise, and 90 minutes after exercise. It will be determined whether the greater amount of sprint exercise in a SIT session will be associated with a greater increase in levels of BDNF in the blood compared to the REHIT session which consists of a lower amount of sprint exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Participants will each undergo 3 trials in a randomised order.
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Apparently health young male volunteers
Key exclusion criteria (7 listed)
- Age <18 y or >40 y
- BMI > 35 kg/m2
- participation in a structured exercise training programme at any time in the preceding 6 months
- suffering from acute (e.g., common cold, Covid-19, flu, etc) or chronic disease (e.g., diabetes, heart disease, cancer, etc)
- answering 'yes' to one or more questions of a standard physical activity readiness questionnaire (PAR-Q)
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 |
|---|---|---|
| Sprint interval training (SIT)The SIT protocol consists of 4 repeated 30-second, 'all-out' cycle sprints against a resistance equivalent to 7.5% of body mass on a stationary bicycle. The first sprint will be preceded by a 4-minute warm-up consisting of unloaded pedalling. Each sprint will be followed by 4 minutes of unloaded pedalling. | Behavioural | – |
| Reduced-exertion high-intensity interval training (REHITThe REHIT protocol consists of 2 repeated 20-second, 'all-out' cycle sprints against a resistance equivalent to 7.5% of body mass on a stationary bicycle. The first sprint will be preceded by a 2-minute warm-up consisting of unloaded pedalling. The first sprint will be followed by 3 minutes of unloaded pedalling, and the second sprint will be followed by 4 minutes of unloaded pedalling. | Behavioural | – |
| No-exercise control (CON)The control condition will involve seated rest for a period equivalent to the other interventions. | Behavioural | – |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of BDNF
Time frame: Pre-exercise, directly post-exercise, and 30 and 90 minutes post-exercise
Plasma levels of the protein brain-derived neurotrophic factor (BDNF) will be measured pre-exercise, directly post-exercise, and 30 and 90 minutes post-exercise. The area-under-the-curve for plasma BDNF will be calculated. Differences in AUC between the 3 trails will be determined.
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 25 Mar 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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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 Sprint interval training (SIT) and Reduced-exertion high-intensity interval training (REHIT in people with Mental Health Wellness 1, 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 1 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 25 Mar 2025. 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?
Area under the plasma concentration versus time curve (AUC) of BDNF (time frame: Pre-exercise, directly post-exercise, and 30 and 90 minutes post-exercise). 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 25 Mar 2025.