Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000539235
Ethics application status
Approved
Date submitted
9/06/2009
Date registered
6/07/2009
Date last updated
6/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Responses of heart rate during isometric exercise in patients undergoing cardiac rehabilitation phase III.
Scientific title
Responses of heart rate during isometric exercise (handgrip) in patients undergoing cardiac rehabilitation phase III.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evaluate the responses of heart rate during three isometric contractions of different intensities in patients with coronary artery disease and / or risk factors for it. 236949 0
Condition category
Condition code
Cardiovascular 237300 237300 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To compare the heart rate response during isometric exercise using a dynamometer Analog palmar prehension (handgrip). Were performed 2 days of sampling with an interval of 5 days between them, consisting of 2 sets of 3 contractions in both days. On the first day of collection performed maximal voluntary contractions in 5 seconds and 10 seconds, held on the second day 30% and 60% of maximum voluntary contraction of 5 seconds.The participants also undergo a program of cardiac rehabilitation for an average duration of 6 months prior to completion of this study (60 minutes per session, 3 times per week, predominantly aerobic, including exercises on a treadmill and cycle ergometer at an intensity between 70 and 75% heart rate reached during the exercise test clinically).
The study was observational prospective.
Intervention code [1] 236728 0
Rehabilitation
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238112 0
Evaluate the responses of heart rate during three isometric contractions of different intensities in patients with coronary artery disease and / or risk factors for it.
The isometric contractions were performed using an analog of palmar prehension dynamometer (Jamar - Sammons Preston, Inc. Bolingbrook, IL, USA), with the patient sitting in a chair with back support and adjustable arm so that the bending angle the forearm maintained at 90.
Timepoint [1] 238112 0
The subjects participated in a program of cardiac rehabilitation for average duration of 6 months prior to completion of this study
when the heart rate was measured.
Secondary outcome [1] 242325 0
Nil
Timepoint [1] 242325 0
Nil

Eligibility
Key inclusion criteria
Individuals with coronary artery disease and / or risk factors for it and were involved in a program of cardiac rehabilitation (Phase III) for at least 6 months
Minimum age
50 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects no submitted in a program of cardiovascular physical therapy, smoking, musculoskeletal and metabolic diseases, alcoholic.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 1830 0
Brazil
State/province [1] 1830 0
Sao Paulo/Sao Carlos

Funding & Sponsors
Funding source category [1] 237127 0
Government body
Name [1] 237127 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (National Council for Scientific an Technological Development)
Country [1] 237127 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 - Nucleo de Pesquisa em Exercicio Fisico / Sao Carlos/Sao Paulo, CEP: 13565-905
Country
Brazil
Secondary sponsor category [1] 4618 0
None
Name [1] 4618 0
Address [1] 4618 0
Country [1] 4618 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239225 0
Ethics Committe of research in humans, Federal University of Sao Carlos
Ethics committee address [1] 239225 0
Washington Luis Highway, Km 235 Federal University of Sao Carlos, Sao Carlos/ Sao Paulo, CEP: 13565-905
Ethics committee country [1] 239225 0
Brazil
Date submitted for ethics approval [1] 239225 0
13/02/2005
Approval date [1] 239225 0
13/04/2005
Ethics approval number [1] 239225 0
071/2005

Summary
Brief summary
The purpose of this study was to evaluate the responses of heart rate during three isometric contractions of different intensities in patients with coronary artery disease and / or risk factors for it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29716 0
Address 29716 0
Country 29716 0
Phone 29716 0
Fax 29716 0
Email 29716 0
Contact person for public queries
Name 12963 0
Aparecida Maria Catai
Address 12963 0
Rodovia Washington Luis km 235
Universidade Federal de Sao Carlos
Laboratorio de Fisioterapia Cardiovascular
Nucleo de Pesquisa em Exercicio Fisico. Sao Paulo, CEP: 13565-905
Country 12963 0
Brazil
Phone 12963 0
+55 16 33518705
Fax 12963 0
+55 16 33612081
Email 12963 0
[email protected]
Contact person for scientific queries
Name 3891 0
Aparecida Maria Catai
Address 3891 0
Rodovia Washington Luis km 235
Universidade Federal de Sao Carlos
Laboratorio de Fisioterapia Cardiovascular
Nucleo de Pesquisa em Exercicio Fisico. Sao Carlos/Sao Paulo.CEP: 13565-905
Country 3891 0
Brazil
Phone 3891 0
+55 16 33518705
Fax 3891 0
+55 16 33612081
Email 3891 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.