NCT06141512

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 23, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

November 13, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

VO2maxMyokineCardiorespiratory Fitness

Outcome Measures

Primary Outcomes (2)

  • Training induced changes in VO2max

    Maximal aerobic capacity (VO2max) will be measured pre- and post-training to determine the change in VO2max.

    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.

    Pre-intervention and 3 days post-intervention

Study Arms (1)

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.

Behavioral: Reduced-exertion high-intensity interval training (REHIT)

Interventions

Description same as Arm description.

Also known as: Sprint interval training (SIT)
Reduced-exertion high-intensity interval training (REHIT)

Eligibility Criteria

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

You may qualify if:

  • Male
  • Age ≥ 18 y or \<40 y
  • BMI \< 35 kg/m2
  • otherwise healthy, untrained individuals

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Stirling

Stirling, 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
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 21, 2023

Study Start

October 23, 2023

Primary Completion

June 30, 2024

Study Completion

June 1, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations