NCT06113133

Brief Summary

To advance the methodology for evaluating persons with heart disease and their maximal oxygen uptake, the primary aim of this study is to investigate the occurrence of a plateau in oxygen uptake. This plateau will be examined for the purpose of assessing VO2 max in persons enrolled in exercise-based cardiac rehabilitation. Furthermore, this study aims to investigate the age-related respiratory exchange ratio, and rating of perceived exertion, and describe their association with the presence of a plateau. Heart disease and characteristics for all participants are obtained. Participants underwent a maximal exercise test on an ergometer cycle with direct measurement of oxygen uptake to assess oxygen plateau attainment. This included measurement of the maximal oxygen uptake, respiratory exchange ratio, heart rate and the ratio of perceived exertion (BORG6-20).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

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

December 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

June 22, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

Physical fitnessheart diseaseoxygen consumption

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

    Cardiopulmonary exercise test by Metalyzer 3B to determine maximal oxygen uptake measured in millimetre oxygen

    Pretest is conducted at the first day in rehabilitation. Posttest is conducted when a participant finish rehabilitation or maximal 1 week after the end of the rehabilitation after 12-weeks

Secondary Outcomes (3)

  • Respiratory exchange ratio

    Respiratory exchange ratio is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.

  • Ratio of perceived exertion

    The participants rate their perceived exertion immediately after CPET is finished at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.

  • Maximal heart rate

    Heart rate is measured during CPET at pretest the first day in rehabilitation. Posttest is conducted the last week of rehabilitation or maximal 1 week after ending the 12-week program.

Study Arms (1)

Maximal oxygen uptake

Measurement of maximal oxygen uptake using \< 50-millilitre and 100 millilitre oxygen as a cut-off

Diagnostic Test: measurement of oxygen uptake

Interventions

oxygen uptake is obtained during a maximal exercise test

Maximal oxygen uptake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants are adults with heart diseases such as ischemia, heart failure and after heart valve surgery

You may qualify if:

  • participants with heart disease referred to exercise-based cardiac rehabilitation in primary healthcare settings were included

You may not qualify if:

  • heart-related symptoms according to clinical guidelines that prevent participants from performing a maximal exercise test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claus Sevel

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Maribo, Professor

    University of Aarhus

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2023

First Posted

November 2, 2023

Study Start

December 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations