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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04774276
Other study ID # IRBN022021/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2020
Est. completion date July 31, 2021

Study information

Verified date August 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
week 5
Primary 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
week 5
Secondary Strength of biceps muscle (Kg) Measured by handgrip
Done one week after the end of cardiac rehabilitation protocol
week 5
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