Minimum Effective Exercise Intensity in Sedentary Individuals (MEI)

February 13, 2026 updated by: Olli-Pekka Nuuttila, UKK Institute

Minimum Effective Exercise Intensity for Improving Cardiorespiratory Fitness and Cardiometabolic Health in Sedentary Individuals

The aim of this randomized controlled intervention study is to examine the minimum exercise intensity that has an effect on cardiorespiratory fitness and/or cardiometabolic risk factors in sedentary adults. In addition, the study seeks to examine which background factors explain individual differences in exercise responses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of a 2-week baseline period followed by two 6-week intervention periods. The study will compare changes in the predefined outcome variables between the exercise intervention groups and the control group that does not perform any exercise training. In addition to intensity prescribed relative to oxygen uptake reserve, exercise intensity will be retrospectively analyzed in relation to the first ventilatory threshold in order to examine the lowest effective intensity using this method as well. Among background factors, possible modifiers assumed on the basis of previous literature, will be analyzed to assess their contribution to inter-individual differences in the outcome responses. Potential main contributors are considered to be sex, the basal value of the outcome, nutritional habits, physical activity and stationary behavior outside the prescribed training, and non-invasive indicators of stress.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33500
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20540
        • Recruiting
        • Paavo Nurmi Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 30-50-year old males and females
  • Sedentary, not participating in regular exercise training/physical activity

Exclusion Criteria:

  • Cardiovascular symptoms/diseases
  • Musculoskeletal symptoms/diseases
  • Metabolic diseases
  • Resting blood pressure > 160/100 mmHg
  • Body mass index ≥ 35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: 30 %/VO2reserve intervention group
Other: Exercise
6 weeks of 3 x 30 min/week supervised cycle ergometer training and 6 weeks of 3 x 40-50 min/week supervised cycle ergometer training
Experimental: 40 %/VO2reserve intervention group
Other: Exercise
6 weeks of 3 x 30 min/week supervised cycle ergometer training and 6 weeks of 3 x 40-50 min/week supervised cycle ergometer training
Experimental: 50 %/VO2reserve intervention group
Other: Exercise
6 weeks of 3 x 30 min/week supervised cycle ergometer training and 6 weeks of 3 x 40-50 min/week supervised cycle ergometer training
Experimental: 60 %/VO2reserve intervention group
Other: Exercise
6 weeks of 3 x 30 min/week supervised cycle ergometer training and 6 weeks of 3 x 40-50 min/week supervised cycle ergometer training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal oxygen consumption
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Assessed with step-ramp-step protocol
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Ventilatory thresholds
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Assessed with step-ramp-step protocol
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pmax
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Maximum power of the ramp cycle ergometer test
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Concentration of LDL cholesterol
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Fasting state blood sample
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Concentration of HDL cholesterol
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Fasting state blood sample
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Concentration of total cholesterol
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Fasting state blood sample
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Concentration of triglycerides
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Fasting state blood sample
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Concentration of blood glucose
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Fasting state blood sample
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Concentration of insulin
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Fasting state blood sample
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
HOMA-IR
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
(Insulin × Glucose) / 22.5
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
HbA1c
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Fasting state blood sample
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Blood pressure
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Systolic and diastolic blood pressure
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Resting heart rate
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
In sitting position
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Resting heart rate variability
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Root mean square of successive differences in sitting position
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Gross efficiency
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Gross efficiency during standard load
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Body weight
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Measured using an electronic scale.
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Waist circumference
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body fat percentage
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Assessed with bioimpedance
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Healthy diet index
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
0-100, higher score means a better outcome.
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
NEO-FFI
Time Frame: Pre (week 0)
Psychological personality inventory
Pre (week 0)
FIMS
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Finnish version of Brunel Mood Scale; It includes 24 items divided into 6 factors: tension, depression, anger, vigour, fatigue, confusion. Each factor has scale from 0 to 16, higher score meaning worse outcome. In addition total mood disturbance = summing the five negative mood dimensions and subtracting vigour. Score can be between -16 and 84 with higher score meaning worse outcome.
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
CD-RISC-25
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
The 25-item Connor-Davidson Resilience Scale: scoring from 0 to 100, where the higher score means better outcome.
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Estimated cardiorespiratory fitness
Time Frame: Pre (screening phase)
Ekblom-Bak test
Pre (screening phase)
Self-estimated fitness and health
Time Frame: Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
One item self-estimated fitness in 1-5 scale where higher score means worse outcome; one item self-estimated health in 1-5 scale where higher score means worse outcome.
Pre (week 0), mid (after 6 weeks), post (after 12 weeks)
Non-exercise fitness test
Time Frame: Pre (screening phase)
Jackson N-eX
Pre (screening phase)
Physical/stationary behavior
Time Frame: Weekly averages throughout the study (Baseline + weeks 1-12)
Measured with an accelerometer 24/7. Physical activity will be distributed into intensity domains according to 1) ACSM 2025 description, and 2) ventilatory thresholds. Stationary behavior will be distributed into sitting, standing and lying.
Weekly averages throughout the study (Baseline + weeks 1-12)
Exercise heart rate
Time Frame: Throughout the study (weeks 1-12)
Heart rate during intervention exercise
Throughout the study (weeks 1-12)
Rating of perceived exertion
Time Frame: Throughout the study (weeks 1-12)
Estimation of perceived exertion during (6-20) and after (0-10) intervention exercises
Throughout the study (weeks 1-12)
Exercise heart rate variability
Time Frame: Week 1, week 6, week 7, week 12
Heart rate variability response to intervention exercise and during 5-min recovery phase
Week 1, week 6, week 7, week 12
Exercise blood lactate
Time Frame: Week 1, week 6, week 7, week 12
Blood lactate response to intervention exercise
Week 1, week 6, week 7, week 12
Exercise motivation
Time Frame: Week 1, week 6, week 7, week 12
Exercise motivation in a 3-item scale based on Eccles' expectancy-value theory with a total score from 3 to 15, where higher score means better outcome
Week 1, week 6, week 7, week 12
State of alertness during exercise
Time Frame: Week 1, week 6, week 7, week 12
State of alertness from a scale 1 (low alertness, relaxed) to 6 (high alertness, aroused)
Week 1, week 6, week 7, week 12
Affective responses to exercise
Time Frame: Week 1, week 6, week 7, week 12
Feeling scale from -5 to 5 with higher value meaning more positive affective response
Week 1, week 6, week 7, week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UKK Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Paavo Nurmi Center & Unit for Health and Physical Activity
Juho Vainion säätiö

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MINI26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study involves group-based training, and complete anonymity of the results cannot be guaranteed with certainty.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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