NCT04774276

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.

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 Nov 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

9 months

First QC Date

February 24, 2021

Last Update Submit

August 21, 2023

Conditions

Keywords

occupational therapyquality of life

Outcome Measures

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

    week 5

Secondary Outcomes (1)

  • Strength of biceps muscle (Kg)

    week 5

Other Outcomes (1)

  • 6 minutes walk test (TM6)

    week 5

Study Arms (2)

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

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

Group without 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 with occupational therapist

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Myocardial InfarctionCoronary Artery Disease

Interventions

Occupational Therapists

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • DAVID HUPIN, MD

    CHU ST ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 1, 2021

Study Start

November 2, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations