Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000049370
Ethics application status
Approved
Date submitted
18/01/2008
Date registered
29/01/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of cardiovascular physiotherapy (phase I of cardiac rehabilitation) on heart rate variability of patients with acute myocardial infarction.
Scientific title
Autonomic modulation of heart rate in patients with acute myocardial infarction submitted to physiotherapy: phase I of cardiac rehabilitation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infartion (AMI) 2727 0
Condition category
Condition code
Cardiovascular 2898 2898 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the the Phase 1 of cardiac rehabilitation, the treated group (TG) was carry out cardiovascular physioterapy protocol (CPP)daily during 6 days, which included periods of rest in supine position, respiratory exercises and dynamic physical exercises performed in different positions (i.e., supine, sitting and standing). The progression of TG in CPP protocol was done based on the daily clinical evaluation of each patient. The patients of TG were always instructed to rest quietly, breath spontaneously and remain awake during the resting conditions. On the other hand, the exercise content of each day differed in body position, duration and intensity. Hereafter, in the 3rd stage, walking was gradually included and carried out at a constant rhythm. The walking intensity was set at 20 beats per minute above the standing resting heart rate. All experimental procedures were performed over 6 days in the Coronary Care Unit (CCU) (two days) and the ward (four days) of the local Hospital. They were initiated 22 hours after the CCU admission. The study had the duration of six years (01/11/04 to 01/12/10)
Intervention code [1] 2469 0
Rehabilitation
Comparator / control treatment
The control group (CG) daily protocol included 10 min of rest in supine position that was followed by 4 min of respiratory exercises. During the resting, the patients were always instructed to rest quietly, breath spontaneously and remain awake. The respiratory exercises were done in supine position and included diaphragmatic pattern and inspiration fractioned in three times. These respiratory exercises were only performed to avoid pulmonary complication that could appear due to bed rest and hospitalization. All experimental procedures were performed daily over 6 days in the Coronary Care Unit (CCU) (two days) and the ward (four days) of the local Hospital. They were initiated 22 hours after the CCU admission.
Control group
Active

Outcomes
Primary outcome [1] 3736 0
To evaluate the effects of cardivascular physiotherapy phase I on heart rate variability (HRV) of post-AMI inpatients. The tools used by measure HRV were linear analysis (time and frequency domain) and non linear analysis ( detrend fluctuation analysis (DFA), power law scaling and DFA spectral)
Timepoint [1] 3736 0
The mesurements of HRV were obtained daily for 6 days.
Secondary outcome [1] 6381 0
To compare linear and non linear analysis of HRV
Timepoint [1] 6381 0
The measurements of HRV for linear and nonlinear analysis were performed daily for 6 days during the supine resting before the begining of CPP.

Eligibility
Key inclusion criteria
patients of both genders, aged above thirty five years old, first non-complicated AMI with ST-segment elevation.
Minimum age
38 Years
Maximum age
66 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
history of previous AMI, AMI complicated, AMI without ST- segment elevation, signs and/or symptoms of post-AMI chest pain or re-infarction, presence of diabetes mellitus associated with cardiac autonomic dysfunction, persistence of altered pressure response (refractory hypertension with levels greater than 180/100 mmHg), atrial fibrillation, malignant ventricular arrhythmias, complex ectopic ventricular beats, supraventricular or sinus tachycardia (greater than 120 beats per minute), 2o and 3o AV block; pacemaker implantation; signs of low output or ventricular failure, hypotension and heart failure; debility, fever state, respiratory insufficiency, chronic obstructive pulmonary disease, illegal drug consumption, sequelas of stroke, lower limb amputation, severe aortic stenosis, severe left main coronary injury (>50%), prior coronary artery bypass graft surgery, inability of protocol progression and hospital entry 48h after the AMI.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 737 0
Brazil
State/province [1] 737 0
Sao Paulo/Ribeirao Preto
Country [2] 738 0
Brazil
State/province [2] 738 0
Sao Paulo/Sao Carlos

Funding & Sponsors
Funding source category [1] 2983 0
Government body
Name [1] 2983 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo (FAPESP)
Country [1] 2983 0
Brazil
Primary sponsor type
University
Name
Federal University of Sao Carlos
Address
Rodovia Washington Luis km 235. Universidade Federal de Sao Carlos Laboratorio de Fisioterapia Cardiovascular. NUPEF.
Country
Brazil
Secondary sponsor category [1] 2692 0
Individual
Name [1] 2692 0
Aparecida Maria Catai
Address [1] 2692 0
Rodovia Washington Luis km 235. Universidade Federal de Sao Carlos Laboratorio de Fisioterapia Cardiovascular. NUPEF.
Country [1] 2692 0
Brazil
Other collaborator category [1] 158 0
Hospital
Name [1] 158 0
Irmandade Santa Casa de Misericordia de Sao Carlos
Address [1] 158 0
Rua Paulino Botelho A. Sampaio, 573 Sao Carlos-SP e
Country [1] 158 0
Brazil
Other collaborator category [2] 164 0
Hospital
Name [2] 164 0
Sociedade Beneficente e Hospitalar Santa Casa de Misericordia de Ribeirao Preto
Address [2] 164 0
Avenida Saudade, 456 - Campos El?seos - Ribeir?o Preto-SP
CEP 14085-000
Country [2] 164 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4936 0
Ethics Committe of Research in Human, Federal University of Sao Carlos
Ethics committee address [1] 4936 0
Ethics committee country [1] 4936 0
Brazil
Date submitted for ethics approval [1] 4936 0
17/08/2006
Approval date [1] 4936 0
19/09/2006
Ethics approval number [1] 4936 0
231/2006
Ethics committee name [2] 4937 0
Ethics Committe of Research in Human, Federal University of Sao Carlos
Ethics committee address [2] 4937 0
Ethics committee country [2] 4937 0
Brazil
Date submitted for ethics approval [2] 4937 0
Approval date [2] 4937 0
05/03/2004
Ethics approval number [2] 4937 0
023/2004
Ethics committee name [3] 4953 0
Ethics Committe of Research in Human, Federal University of Sao Carlos
Ethics committee address [3] 4953 0
Ethics committee country [3] 4953 0
Brazil
Date submitted for ethics approval [3] 4953 0
Approval date [3] 4953 0
23/11/2005
Ethics approval number [3] 4953 0
226/2005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28307 0
Address 28307 0
Country 28307 0
Phone 28307 0
Fax 28307 0
Email 28307 0
Contact person for public queries
Name 11464 0
Aparecida Maria Catai
Address 11464 0
Rodovia Washington Luis km 235. Universidade Federal de Sao Carlos Laboratorio de Fisioterapia Cardiovascular. NUPEF.
Country 11464 0
Brazil
Phone 11464 0
55 16 33518705
Fax 11464 0
55 16 33612081
Email 11464 0
[email protected]
Contact person for scientific queries
Name 2392 0
Aparecida Maria Catai
Address 2392 0
Rodovia Washington Luis km 235. Universidade Federal de Sao Carlos Laboratorio de Fisioterapia Cardiovascular. NUPEF.
Country 2392 0
Brazil
Phone 2392 0
55 16 33518705
Fax 2392 0
55 16 33612081
Email 2392 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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