NCT06941597

Brief Summary

Cardiovascular disease (CVD) is the leading cause of death in France for women and the second leading cause of death for men after cancer. They cause around 140,000 deaths every year, or almost 400 people every day throughout France. CVD also accounts for over a million hospital admissions a year, 160,000 of which are attributable to heart failure. At present, cardiovascular rehabilitation centres mainly use exercise training methods based on sessions on cycloergometers and active walking (walking on a track and/or treadmill). Convinced of the added value of Orienteering, we have included it in our routine treatment as part of our Cardiac Rehabilitation programme, in addition to sessions on cycloergometers and active walking since 2021. As there is little literature on the subject in our population of interest, the aim of this study is to provide evidence of the relevance of orienteering in the cardiac rehabilitation programme. We hypothesise that orienteering induces a similar cardiac response, amount of physical activity and perception of symptoms compared with an active walking session, while providing greater enjoyment of the activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

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

First Submitted

Initial submission to the registry

April 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
Last Updated

December 24, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 16, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

cardiovascular diseasescardiac rehabilitationactive walkingorienteeringheart rate

Outcome Measures

Primary Outcomes (1)

  • To compare the average heart rate between an active walking session and an orientation walking session during the cardiac rehabilitation stay.

    Average heart rate measured during the active walking session and the orienteering race.

    once during the second and third week of cardiac rehabilitation

Secondary Outcomes (9)

  • To compare the intensity of effort between the active walking, orienteering and cycloergometer sessions.

    once during the second and third week of cardiac rehabilitation

  • To compare the intensity of effort between the active walking, orienteering and cycloergometer sessions.

    once during the second and third week of cardiac rehabilitation

  • Compare the performance of the physical activity performed during the active walking versus orienteering session.

    once during the second and third week of cardiac rehabilitation

  • Compare the performance of the physical activity performed during the active walking versus orienteering session.

    once during the second and third week of cardiac rehabilitation

  • Compare the performance of the physical activity performed during the active walking versus orienteering session.

    once during the second and third week of cardiac rehabilitation

  • +4 more secondary outcomes

Study Arms (1)

cardiac rehabilitation group

The management of patients included in this study is unchanged from that usually recommended. The patients included in the study will undergo the same rehabilitation sessions during their stay as patients coming to the centre as a matter of routine. In total, 3 sessions of active walking, 3 sessions of orienteering and 7 sessions of ergocycles were carried out during the stay. The cardiac rehabilitation programme lasted 3 weeks, and all the sessions evaluated as part of the study (active walking, orienteering and ergocycles) were carried out during the last two weeks of the rehabilitation course. For each activity (active walking and orienteering), a familiarisation session will be carried out before the session evaluated as part of the study. The order in which the orientation walking and active walking sessions are carried out will depend on the weeks in which the subjects are included, and may vary according to the organisation of the centre.

Eligibility Criteria

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

The participants are patients undergoing cardiac rehabilitation in the SSR cardiology department of the Ildys Foundation on the Ty Yann site.

You may qualify if:

  • Patients with stabilised heart disease, coronary artery disease, heart failure, post-operative stay after cardiac surgery, congenital heart disease, patients at high cardiovascular risk and obliterative arteritis of the lower limbs;
  • Who have been informed and do not object to the study;
  • Over 18 years of age;
  • Participating in a cardiac rehabilitation programme;
  • With a walking distance of less than 3,600 metres;
  • Able to understand and comply with the requirements of the protocol.

You may not qualify if:

  • Pregnant or breast-feeding women
  • Persons under guardianship or trusteeship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation ILDYS, Site de Ty Yann

Brest, France

Location

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart FailureHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Klervie BAILLY

    Fondation Ildys

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2025

First Posted

April 24, 2025

Study Start

April 28, 2025

Primary Completion

October 5, 2025

Study Completion

October 5, 2025

Last Updated

December 24, 2025

Record last verified: 2025-04

Locations