NCT06069427

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

September 27, 2023

Last Update Submit

March 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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.

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.

The control condition will involve seated rest for a period equivalent to the other interventions.

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently health young male volunteers

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Stirling

Stirling, Midlothian, FK9 4LA, United Kingdom

Location

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Niels Vollaard, PhD

    University of Stirling

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Due to the nature of the interventions (exercise), masking is not possible.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Participants will each undergo 3 trials in a randomised order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 5, 2023

Study Start

November 15, 2023

Primary Completion

July 30, 2024

Study Completion

December 31, 2024

Last Updated

March 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data.

Locations