Condition category
Circulatory System
Date applied
21/04/2010
Date assigned
27/05/2010
Last edited
11/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiovascular (heart) disease (CVD) is a health problem of the first order all over the world. In Europe, CVD is the leading cause of death and has a huge impact on the health budget. Myocardial ischemia (MI) occurs when blood flow to the heart is reduced, preventing it from receiving enough oxygen. Survival rates after MI have increased in recent years, and a large number of MI survivors are discharged from the hospital into the community and are at a high risk of readmission. Cardiac rehabilitation programmes (CRPs) provide regular secondary prevention therapies and assessments by a team of professionals who offer continued education and resolve patients’ doubts during the period after a MI. CRPs decrease mortality and the risk of recurrent MI, promote a healthy lifestyle and improve functional capacity among patients with coronary heart disease. Most studies on post-MI survival, readmissions and physical rehabilitation agree that physical exercise reduces mortality, but its impact on readmissions has not been conclusively established. While many studies have found no differences in readmissions after CRP, others report that CRPs reduced cardiac readmission rates (by between 17% and 79%). Moreover, the few studies available on the issue do not focus on identifying the best exercise regimens for reducing readmissions. Evidence that these programmes reduce readmission would provide an additional incentive for hospitals and providers to refer their patients to a CRP after a MI. The aim of this study is to assess the effectiveness of a supervised exercise training programme for reducing cardiac readmissions in patients with MI in the first year after hospital discharge.

Who can participate?
Patients aged over 18 with MI

What does the study involve?
Participants are randomly allocated either to a control group to receive standard care, or to an intervention group which, in addition to standard care, takes part in a supervised exercise training program consisting of three hours a week (spread over three alternate days) of supervised exercise training for 10 weeks. Both groups undergo an exercise stress test and a blood test during the first and third month after hospital discharge. The study also explores differences between groups in readmission, death, hospital emergency visits, functional capacity, quality of life, adherence to cardiac pharmacological treatment, attendance at nurse follow-up visits, satisfaction with care received, and return to work. The follow-up period is 12 months after hospital discharge.

What are the possible benefits and risks of participating?
Reducing cardiac readmissions and improving quality of life and functional status of the patient accelerate return to normal life and shorten recovery time. In addition, during admission and follow-up, the patient and family receive detailed information on lifestyle habits, physical exercise and aspects to consider in order to favour active control of the disease by the patient and to increase safety, both highly important factors for reducing the number of readmissions. From the standpoint of health planning and management, the findings of the study may entail substantial savings in the budgets of health services in the country, reducing readmissions and the total length of hospitalization in a disease as frequent as MI. Thus, this study may encourage the use of supervised exercise training programs in CRP. The intervention is not overly complex and can be performed easily by well-trained health professionals, and could be widely applied.

Where is the study run from?
Althaia, Xarxa Assistencial Universitària de Manresa (Spain)

When is the study starting and how long is it expected to run for?
May 2010 to December 2018

Who is funding the study?
Fundació Althaia (Spain) - Xarxa Assistencial Universitària de Manresa

Who is the main contact?
Dr Núria Santaularia Capdevila

Trial website

Contact information

Type

Scientific

Primary contact

Dr Núria Santaularia Capdevila

ORCID ID

http://orcid.org/0000-0002-0453-1402

Contact details

C/Dr. Joan Soler 1-3
Manresa
08243
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R01/08-09

Study information

Scientific title

Randomised hospital-based clinical trial on the efficacy of an exercise training programme versus care as usual for adult patients with ischaemic cardiopathy

Acronym

Study hypothesis

Primary hypothesis:
Cardiac rehabilitation programmes decrease the number of hospital readmissions of patients diagnosed of ischaemic cardiopathy.

Secondary hypotheses:
1. Patients with ischaemic cardiopathy who join a cardiac rehabilitation programme obtain a better functional capacity than patients who receive the usual therapy
2. Health-related quality of life is better in patients who enrol in a cardiac rehabilitation programme than in those who receive the usual therapy

Ethics approval

Comitè Ètic d’Investigació Clínica de la Fundació Unió Catalana d’Hospitals, 30/06/2009, ref: CEIC 09/38

Study design

Open randomised single-centre hospital-based clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Ischaemic cardiopathy

Intervention

Control group:
Patients will receive the usual therapy of our hospital. Hospitalised patients will be instructed to do exercises to regain mobility in order to maintain and improve muscular tone and peripheral circulation. They will be instructed on how to return to physical activity and receive information on cardiovascular risk factors. Written information will be provided.

After hospital discharge, patients will undergo a physical strength test at 15 days and at 3 months and will have ambulatory follow-up with a nurse at 15 days, 3, 6 and 12 months from hospital discharge in order to control the risk factors and review adherence to medication. During these visits, various tests will be administered and control blood tests will be performed.

Intervention group:
The intervention will consist of a physical training programme, personalised according to the results of the physical strength test performed 15 days after discharge. The programme consists of 3 hours a week of supervised training during 10 weeks. The following activities will be performed: initial warm-up, muscle stretching, aerobic exercises (cycloergometer and/or treadmill), isometric exercises of upper and lower extremities, relaxation exercises, breathing techniques and final cooling. Moreover, instructions will be given on self-pulse counting, subjective perception of effort using Börg scale, postural health and minimizing physical effort.

After hospital discharge, the patients will undergo a physical strength test at 15 days and at 3 months and will have ambulatory follow-ups with a nurse at 15 days, 3, 6 and 12 months from hospital discharge in order to control risk factors and assess adherence to medication. During these visits, various tests will be administered and control blood tests will be performed.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Number of admissions for any reason during period of follow-up, measured at 15 days, 3, 6 and 12 months
2. Number of admissions with main cardiac diagnosis at discharge during period of follow-up, measured at 15 days, 3, 6 and 12 months
3. Time from first admission, measured at 15 days, 3, 6 and 12 months
4. Percentage of patients readmitted during period of follow-up, measured at 15 days, 3, 6 and 12 months
5. Total days of hospitalisation for any reason during period of follow-up, measured at 15 days, 3, 6 and 12 months
6. Total days of hospitalisation for cardiac event during period of follow-up, measured at 15 days, 3, 6 and 12 months
7. Functional status according to physical strength test, measured at 15 days and at 3 months
8. Mortality, measured at 15 days, 3, 6 and 12 months

Added 21/03/2018:
All outcomes are also measured at 5 years

Secondary outcome measures

Initial outcomes at time of registration:
1. Adherence to cardiac rehabilitation programme, according to attendance to follow-up visits and training sessions, measured at 15 days, 3, 6 and 12 months
2. Adherence to medication, according Haynes-Sackett test, measured at 15 days, 3, 6 and 12 months
3. Quality of life, assessed using SF-36 test at 15 days, 3 and 12 months from hospital discharge
4. Degree of patients' satisfaction with assistance received. The Ambulatory Specialised Care 2008 questionnaire of Servei Català de la Salut will be used; questions selected from the questionnaire on satisfaction of policy holders of CatSalut for services offered: Ambulatory Specialised Care 2008. This will be administered 12 months after hospital discharge

As of 24/06/2010 point 3 has been amended as follows:
3. Quality of life, assessed using EuroQoL test (Spanish version) at 15 days, 3 and 12 months from hospital discharge

Added 21/03/2018:
1. All-cause hospital emergency visits, assessed at 12 months and 5 years of follow-up
2. Functional status according to Caspersen & Powell classification and IPAQ questionnaire, assessed at 5 years of follow-up.
3. Return to work, assessed at 12 months and 5 years of follow-up
Adherence to medication and quality of life also assessed as above at 5 years of follow-up

Overall trial start date

10/05/2010

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients over 18 years old (either sex), autonomous and able to take decisions, who accept to participate in the study
2. Patients diagnosed with ischaemic cardiopathy admitted to the Cardiology Service at our centre
3. Patients without cognitive deficit, able to follow the cardiac rehabilitation programme
4. Patients with cardiopathy, residing in the service area of Althaia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

292 patients (146 patients in each group)

Participant exclusion criteria

1. Patients under 18 years old
2. Patients with symptoms of cor pulmonale
3. Patients with additional diagnosis affecting prognosis of cardiac disease
4. Patients with dyspnoea caused by severe pulmonary pathology
5. Patients with cardiopathy residing outside the service area of Althaia
6. Patients who do not accept to participate in the study

Recruitment start date

01/06/2010

Recruitment end date

19/06/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Althaia, Xarxa Assistencial Universitària de Manresa
C/Dr Joan Soler, 1-3 Manresa
Barcelona
08243
Spain

Sponsor information

Organisation

Fundació Althaia (Spain) - Xarxa Assistencial Universitària de Manresa

Sponsor details

C/ Dr. Joan Soler
1-3
Manresa
08243
Spain

Sponsor type

Research organisation

Website

http://www.althaia.cat/

Funders

Funder type

Hospital/treatment centre

Funder name

Fundació Althaia (Spain) - Xarxa Assistencial Universitària de Manresa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

College of Physiotherapists of Catalonia (Collegi de Fisioterapeutes de Catalunya) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Departament de Salut. Acció instrumental d’intensificació de professionals de la Salut en fisioteràpia (SLT006/17/00186).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23617767
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/27162127

Publication citations

  1. Protocol

    Santaularia N, Caminal J, Arnau A, Perramon M, Montesinos J, Trapé J, Abenoza-Guardiola M, Guiteras-Val P, Jaarsma T, Randomized clinical trial to evaluate the effect of a supervised exercise training program on readmissions in patients with myocardial ischemia: a study protocol., BMC Cardiovasc Disord, 2013, 13, 1, 32, doi: 10.1186/1471-2261-13-32.

  2. Results

    Santaularia N, Caminal J, Arnau A, Perramon M, Montesinos J, Abenoza Guardiola M, Jaarsma T, The efficacy of a supervised exercise training programme on readmission rates in patients with myocardial ischemia: results from a randomised controlled trial., Eur J Cardiovasc Nurs, 2017 , 16, 3, 201-212, doi: 10.1177/1474515116648801.

Additional files

Editorial Notes

11/04/2018: Plain English summary, recruitment dates, publication and dissemination plan and IPD sharing statement added. 21/03/2018: The following changes were made to the trial record: 1. The overall trial end date was changed from 10/05/2012 to 30/12/2018. 2. The following funder was added: Departament de Salut. Acció instrumental d’intensificació de professionals de la Salut en fisioteràpia (SLT006/17/00186) 3. Publication reference added.