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Recruiting NCT07418619

Minimum Effective Exercise Intensity in Sedentary Individuals

No phase Interventional Sedentary Individuals Not Participating in Regular Exercise Training/Physical Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Sedentary Individuals Not Participating in Regular Exercise Training/Physical Activity. Basic parameters: 30 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Maximal oxygen consumption [Time frame: 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)]
Secondary outcome measures (12)
  • Pmax [Time frame: 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)]
  • Concentration of HDL cholesterol [Time frame: 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)]
  • Concentration of triglycerides [Time frame: 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)]
  • Concentration of insulin [Time frame: 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)]
  • HbA1c [Time frame: 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)]
  • Resting heart rate [Time frame: 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Basic science

Study locations

Finland · 2 centers
  • UKK institute for Health Promotion Research — Tampere
  • Paavo Nurmi Centre — Turku

Identifiers

NCT: NCT07418619 · MINI26

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗