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 dInvestigació Clínica de la Fundació Unió Catalana dHospitals 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
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
-
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.