Myocardial InfarctionNCT04774276
Protocol in Reeducation Occupational Therapist in Coronary Patients
An observational study of Myocardial Infarction and Coronary Artery Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- cardiac rehabilitation protocol without occupational therapist and cardiac rehabilitation protocol with occupational therapist
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease (CAD) needed a cardiac rehabilitation protocol
Who may be able to join
- Coronary artery disease
- Included in the cardiac rehabilitation protocol in Saint Etienne university hospital
Who cannot join
- Patients who not perform all sessions of the cardiac rehabilitation protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- cardiac rehabilitation protocol without occupational therapist, cardiac rehabilitation protocol with occupational therapist
- Keywords
- occupational therapy, quality of life
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac rehabilitation protocol without occupational therapistOther
cardiac rehabilitation protocol without occupational therapist will be performed (usual practice before January 2021).
cardiac rehabilitation protocol with occupational therapistOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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, Receives: Other: cardiac rehabilitation protocol without occupational therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 5
Secondary outcomes (1)
Strength of biceps muscle (Kg)
Measured by handgrip
Done one week after the end of cardiac rehabilitation protocol
Measured: week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start2 Nov 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DAVID HUPIN, MD, Principal investigator, CHU ST ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774276
- Sponsor's protocol ID
- IRBN022021/CHUSTE
- Status last verified
- Aug 2023
- First submitted
- 24 Feb 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol in Reeducation Occupational Therapist in Coronary Patients
- ClinicalTrials.gov ID
- NCT04774276
- Acronym / sponsor ID
- IRBN022021/CHUSTE
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- occupational therapy, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with occupational therapist | – | Other: cardiac rehabilitation protocol with occupational therapistPatient 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. |
| Group without occupational therapist | – | Other: cardiac rehabilitation protocol without occupational therapistPatient 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease (CAD) needed a cardiac rehabilitation protocol
Key inclusion criteria (2 listed)
- Coronary artery disease
- Included in the cardiac rehabilitation protocol in Saint Etienne university hospital
Key exclusion criteria (1 listed)
- Patients who not perform all sessions of the cardiac rehabilitation protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac rehabilitation protocol without occupational therapistcardiac rehabilitation protocol without occupational therapist will be performed (usual practice before January 2021). | Other | Group without occupational therapist |
| cardiac rehabilitation protocol with occupational therapistThis 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. | Other | Group with occupational therapist |
Primary outcome
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
1 secondary outcome
Strength of biceps muscle (Kg)
Time frame: week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DAVID HUPIN, MD principal investigator
CHU ST ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Coronary Artery Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form (SF-36) questionnaire score (time frame: week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.