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Protocol in Reeducation Occupational Therapist in Coronary Patients

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ClinicalTrials.gov Identifier: NCT04774276
Recruitment Status : Recruiting
First Posted : March 1, 2021
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Myocardial Infarction Coronary Artery Disease Other: cardiac rehabilitation protocol without occupational therapist Other: cardiac rehabilitation protocol with occupational therapist

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Protocol in Reeducation Occupational Therapist in Coronary Patients
Actual Study Start Date : November 2, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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

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


Outcome Measures
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Primary Outcome Measures :
  1. Short Form (SF-36) questionnaire score [ Time Frame: week 5 ]

    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



Secondary Outcome Measures :
  1. Strength of biceps muscle (Kg) [ Time Frame: week 5 ]

    Measured by handgrip

    Done one week after the end of cardiac rehabilitation protocol



Other Outcome Measures:
  1. 6 minutes walk test (TM6) [ Time Frame: week 5 ]

    Measured by the distance in metres at the walking time of 6 minutes.

    Done one week after the end of cardiac rehabilitation protocol



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease (CAD) needed a cardiac rehabilitation protocol
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who not perform all sessions of the cardiac rehabilitation protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774276


Contacts
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Contact: DAVID HUPIN, MD (0)477828413 ext +33 david.hupin@chu-st-etienne.fr
Contact: Frédéric ROCHE, MD PhD frederic.roche@chu-st-etienne.fr

Locations
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France
CHU de Saint-Etienne Recruiting
Saint-Étienne, France, 42055
Principal Investigator: David HUPIN, MD         
Sub-Investigator: Frédéric ROCHE, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: DAVID HUPIN, MD CHU ST ETIENNE
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04774276    
Other Study ID Numbers: IRBN022021/CHUSTE
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
occupational therapy
quality of life
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases