- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418619
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
Recruiting
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
100
Phase
- 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
- Name: Olli-Pekka S Nuuttila, PhD
- Phone Number: +358505946170
- Email: olli-pekka.nuuttila@ukkinstituutti.fi
Study Locations
-
-
Pirkanmaa
-
Tampere, Pirkanmaa, Finland, 33500
- Recruiting
- UKK institute for Health Promotion Research
-
Contact:
- Olli-Pekka Nuuttila, PhD
- Phone Number: +35850 594 6170
- Email: olli-pekka.nuuttila@ukkinstituutti.fi
-
-
Southwest Finland
-
Turku, Southwest Finland, Finland, 20540
- Recruiting
- Paavo Nurmi Centre
-
Contact:
- Pekka Matomäki, PhD
- Phone Number: +358449828506
- Email: pekka.j.matomaki@jyu.fi
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
|
Experimental: 30 %/VO2reserve intervention group
|
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
|
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
|
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
|
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
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
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
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
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)
February 23, 2026
Primary Completion (Estimated)
December 20, 2026
Study Completion (Estimated)
December 20, 2026
Study Registration Dates
First Submitted
January 20, 2026
First Submitted That Met QC Criteria
February 13, 2026
First Posted (Actual)
February 18, 2026
Study Record Updates
Last Update Posted (Actual)
February 18, 2026
Last Update Submitted That Met QC Criteria
February 13, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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