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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06069427
Other study ID # 14395
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University of Stirling
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 13
Est. completion date December 31, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Apparently health young male volunteers Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Reduced-exertion high-intensity interval training (REHIT
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)
The control condition will involve seated rest for a period equivalent to the other interventions.

Locations

Country Name City State
United Kingdom University of Stirling Stirling Midlothian

Sponsors (1)

Lead Sponsor Collaborator
University of Stirling

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pre-exercise, directly post-exercise, and 30 and 90 minutes post-exercise
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