NCT07418619

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 20, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

January 20, 2026

Last Update Submit

February 13, 2026

Conditions

Sedentary Individuals Not Participating in Regular Exercise Training/Physical Activity

Keywords

cardiorespiratory fitnesscardiometabolic healthexercise trainingexercise intensity

Outcome Measures

Primary Outcomes (2)

  • Maximal oxygen consumption

    Assessed with step-ramp-step protocol

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • Ventilatory thresholds

    Assessed with step-ramp-step protocol

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

Secondary Outcomes (15)

  • Pmax

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • Concentration of LDL cholesterol

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • Concentration of HDL cholesterol

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • Concentration of total cholesterol

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • Concentration of triglycerides

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • +10 more secondary outcomes

Other Outcomes (16)

  • Body fat percentage

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • Healthy diet index

    Pre (week 0), mid (after 6 weeks), post (after 12 weeks)

  • NEO-FFI

    Pre (week 0)

  • +13 more other outcomes

Study Arms (5)

30 %/VO2reserve intervention group

EXPERIMENTAL
Other: Exercise

40 %/VO2reserve intervention group

EXPERIMENTAL
Other: Exercise

50 %/VO2reserve intervention group

EXPERIMENTAL
Other: Exercise

60 %/VO2reserve intervention group

EXPERIMENTAL
Other: Exercise

Control group

NO INTERVENTION

Interventions

ExerciseOTHER

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

30 %/VO2reserve intervention group40 %/VO2reserve intervention group50 %/VO2reserve intervention group60 %/VO2reserve intervention group

Eligibility Criteria

Age30 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMales, females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UKK institute for Health Promotion Research

Tampere, Pirkanmaa, 33500, Finland

RECRUITING

Paavo Nurmi Centre

Turku, Southwest Finland, 20540, Finland

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Olli-Pekka S Nuuttila, PhD

CONTACT

+358505946170olli-pekka.nuuttila@ukkinstituutti.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Four parallel intervention groups and control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Exercise physiologist

Study Record Dates

First Submitted

January 20, 2026

First Posted

February 18, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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

Locations

FI(2)