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Efficacy of an exercise training programme for patients with ischaemic cardiopathy
ISRCTN ISRCTN57634424
DOI 10.1186/ISRCTN57634424
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy of an exercise training programme for patients with ischaemic cardiopathy
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 N/A
Serial number at source R01/08-09
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
Lay summary Not provided at time of registration
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
Countries of recruitment Spain
Disease/condition/study domain Ischaemic cardiopathy
Participants - 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
Participants - 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
Anticipated start date 10/05/2010
Anticipated end date 10/05/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 292 patients (146 patients in each group)
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding 1. Fundació Althaia (Spain) - Xarxa Assistencial de Manresa
2. College of Physiotherapists of Catalonia (Col.legi de Fisioterapeutes de Catalunya) (Spain)
Trial website
Publications 1. 2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23617767
Contact name Ms  Núria  Santaularia Capdevila
  Address Passeig Pere III, nº 53, 3º 3º
  City/town Manresa
  Zip/Postcode 08242
  Country Spain
Sponsor Fundació Althaia (Spain) - Xarxa Assistencial de Manresa
  Address C/ Dr.Joan Soler, 1-3
  City/town Manresa
  Zip/Postcode 08243
  Country Spain
  Sponsor website: http://www.althaia.cat/
Date applied 21/04/2010
Last edited 07/05/2013
Date ISRCTN assigned 27/05/2010
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