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Trial registered on ANZCTR
Registration number
ACTRN12611000131954
Ethics application status
Approved
Date submitted
27/01/2011
Date registered
4/02/2011
Date last updated
4/02/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effects of aerobic and resistance training on cardiovascular responses of active elderly people
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Scientific title
To evaluate the effects of 12 weeks of aerobic and resistance training, followed by 4 weeks of detraining, on cardiovascular responses of healthy elderly.
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Secondary ID [1]
253478
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Nil
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Universal Trial Number (UTN)
U1111-1119-2257
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
exercise and cardiovascular responses in healthy elderly
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Hypertension
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Condition category
Condition code
Cardiovascular
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0
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Hypertension
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Cardiovascular
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0
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Normal development and function of the cardiovascular system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Eleven healthy elderly individuals (both genders, 70+/-5 years) performed a exercise program twice a week for 12 weeks. Each 60 minutes session included 20 minutes of walking at 50-70% of maximal heart rate followed by resistive exercises for lower body muscle groups with level set at 65% of 10 repetition maximum (10-RM) for the first four weeks, 70% for the next four weeks and 75% for the last four weeks. The sessions were administred to 10-15 people group by a physiotherapist and 2 students from the course in physical therapy. The variables were measured before, each 4 weeks during training and 4 weeks after training by 6 minute walk test, blood pressure and heart rate before, immediately after, 5 and 10 minutes after the test.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Prevention
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Intervention code [3]
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Lifestyle
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Blood pressure and heart rate were measured before, immediately after, 5 and 10 minutes after the 6 minute walk test.
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Assessment method [1]
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Timepoint [1]
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At baseline and at 4, 8 and 12 weeks of training and at 4 weeks of detraining
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Secondary outcome [1]
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Cardio-respiratory performance was evaluated using the 6 minute walk test.
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Assessment method [1]
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Timepoint [1]
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At baseline and at 4, 8 and 12 weeks of training and at 4 weeks of detraining
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Eligibility
Key inclusion criteria
Men and women over 60 years of age and in a stable health condition; users of the Brazilian National Health System (SUS); presenting a medical certificate affirming they were able to carry out the proposed exercises; and individuals who had not carried out regular physical activity for more than 1 day a week during the previous 6 weeks, were included.
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Minimum age
60
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
The participants were excluded if they had secondary joint injury or surgery; cardiac illness; cancer; neuropathies; were users of prosthesis; had a systolic blood pressure above 200 mmHg and diastolic blood pressure above 110 mmHg at rest; had any contraindications for exercise; severe functional limitations or cognitive impairment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study was an experimental, intentional distribution, uncontrolled clinical trial. The participants were recruited at meetings organized by the Municipal Health secretary of Matinhos-PR, via advertisements on the local radio, and information talks at local community and senior citizen groups. It was asked if the person would like to do exercise or only to be evaluated.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
3158
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Universidade Federal do Parana
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Address [1]
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R. Jaguariaiva, 512 Matinhos Parana Brasil 83260-000
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Country [1]
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Brazil
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Primary sponsor type
University
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Name
Universidade Federal do Parana
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Address
R. Jaguariaiva, 512 Matinhos Parana Brasil 83260-000
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Country
Brazil
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Secondary sponsor category [1]
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University
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Name [1]
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Physiotherapy Clinic School of Universidade Federal do Parana
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Address [1]
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R. Arthur Zanluti, 1402 Matinhos-PR Brasil 83260-000
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Country [1]
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Brazil
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee of the Federal University of Parana Health Sciences
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Ethics committee address [1]
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R. Padre Camargo, 280 - Alto da Gloria - Curitiba - Parana - 80060-240
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Ethics committee country [1]
260369
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Brazil
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Date submitted for ethics approval [1]
260369
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05/09/2008
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Approval date [1]
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24/09/2008
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Ethics approval number [1]
260369
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CAAE-0057.0.091.000-08
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Summary
Brief summary
Aim: Evaluate the effects of the association of resistive and aerobic exercises training on cardiovascular responses in elderly. Methods: Eleven subjects (both genders, 70±5 years) performed twice a week walking and resistive exercises for lower body muscle groups for twelve weeks. The variables were measured before; each four weeks during training and four weeks detraining by six minute walk test, blood pressure (BP) and heart rate (HR) before, immediately after, five and 10 minutes after the test.
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Trial website
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Trial related presentations / publications
Part of this study was presentedd as an abstract in The 19th IAGG Congress of Gerontology and Geriatrics (2009) and XIX Jornada Paranaense de Geriatria e Gerontologia (2009)
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Rafaella Ribas Locks
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Address
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R. Eduardo Carlos Pereira, 4021, apto 802 - Portao - Curitiba - Parana - 81020-770
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Country
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Brazil
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Phone
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55-41-96154487
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Anna Raquel Silveira Gomes
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Address
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R. Jaguariaiva, 512 - Matinhos - Parana - 83260-000
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Country
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Brazil
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Phone
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55-41-35118300
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Fax
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Email
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[email protected]
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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.
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