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CompletedNCT04774276Updated Aug 22, 2023

Protocol in Reeducation Occupational Therapist in Coronary Patients

An observational study in Myocardial Infarction and Coronary Artery Disease, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

The quality of life, linked to physical, social and mental performance in people with coronary heart disease represents the primary goals in terms of rehabilitation. This is often developed to meet the expected performance standard in order to give the person effective autonomy. However, is the occupational balance always evaluated? and this management adapted? Does occupational therapist, expert in autonomy and independence in multiple illnesses and disabilities, has a major role to play in cardiac rehabilitation? This area of expertise and the application of occupational therapy to coronary patients seems appropriate, if not necessary. However, there are few scientific studies on the need to include occupational therapy within cardiac rehabilitation protocols.

Read the detailed description

The occupational therapy goals are in line with the theoretical objectives of coronary rehabilitation. At present, there is a lack of data on the benefits of coronary occupational therapy rehabilitation.

Goals : Evaluation of the quality of life of coronary heart patients who have benefited from cardiac rehabilitation optimized by secondary occupational therapy sessions:

Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.

Evaluation of aerobic and anaerobic performance of coronary heart patients who have benefited from cardiac rehabilitation optimized by occupational therapy sessions.

02

Conditions studied

  • Myocardial Infarction
  • Coronary Artery Disease

Keywords

  • occupational therapy
  • quality of life
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 40 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with coronary artery disease (CAD) needed a cardiac rehabilitation protocol

Inclusion criteria

  • Coronary artery disease
  • Included in the cardiac rehabilitation protocol in Saint Etienne university hospital

Exclusion criteria

Exclusion Criteria:

  • Patients who not perform all sessions of the cardiac rehabilitation protocol
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Group with occupational therapist

    Patient with Coronary Artery Disease (CAD) will be included. They will have the cardiac rehabilitation protocol (4 weeks) with occupational therapist as usual practice. The inclusion in this group will be prospective, from January 2021.

    Other: cardiac rehabilitation protocol with occupational therapist

  • Group without occupational therapist

    Patient with Coronary Artery Disease (CAD) will be included. They have done the cardiac rehabilitation protocol (4 weeks) without occupational therapist until december 2020. The inclusion in this group will be retrospective,

    Other: cardiac rehabilitation protocol without occupational therapist

Interventions

  • Othercardiac rehabilitation protocol without occupational therapist

    cardiac rehabilitation protocol without occupational therapist will be performed (usual practice before January 2021).

  • Othercardiac rehabilitation protocol with occupational therapist

    This intervention (occupational therapist) have been added since 2021 for all patients who need a cardiac rehabilitation protocol. Occupational therapy is scheduled with sessions 3 times a week for 1 month.

06

What researchers measure

Primary outcomes

  1. Short Form (SF-36) questionnaire score

    The SF-36 is a self-questionnaire to assess the quality of life and contains 36 items with minimum score 0 (bad quality life) and maximum score at 100 (good quality life). Done one week after the end of cardiac rehabilitation protocol

    Time frame: week 5

Secondary outcomes

  1. Strength of biceps muscle (Kg)

    Measured by handgrip Done one week after the end of cardiac rehabilitation protocol

    Time frame: week 5

Other outcomes

  1. 6 minutes walk test (TM6)

    Measured by the distance in metres at the walking time of 6 minutes. Done one week after the end of cardiac rehabilitation protocol

    Time frame: week 5

07

Study locations

1 site
  • CHU de Saint-Etienne
    Saint-Étienne, 42055, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04774276
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Mar 1, 2021
Start date
Nov 2, 2020
Primary completion
Jul 31, 2021
Completion
Jul 31, 2021
Last update
Aug 22, 2023

Study contacts

DAVID HUPIN, MD
principal investigator · CHU ST ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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