Condition category
Circulatory System
Date applied
21/04/2010
Date assigned
27/05/2010
Last edited
07/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Núria Santaularia Capdevila

ORCID ID

Contact details

Passeig Pere III
nº 53
3º 3º
Manresa
08242
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 approved on the 30th June 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 below 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.

Alter 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

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: using SF-36 test. Assessment 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.

Overall trial start date

10/05/2010

Overall trial end date

10/05/2012

Reason abandoned

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

10/05/2010

Recruitment end date

10/05/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Passeig Pere III, nº 53, 3º 3º
Manresa
08242
Spain

Sponsor information

Organisation

Fundació Althaia (Spain) - Xarxa Assistencial 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 de Manresa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

College of Physiotherapists of Catalonia (Col.legi de Fisioterapeutes de Catalunya) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23617767

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.

Additional files

Editorial Notes