Trial Review

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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
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.
Secondary ID [1] 253478 0
Nil
Universal Trial Number (UTN)
U1111-1119-2257
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
exercise and cardiovascular responses in healthy elderly 261027 0
Hypertension 261028 0
Condition category
Condition code
Cardiovascular 259167 259167 0 0
Hypertension
Cardiovascular 259168 259168 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257964 0
Treatment: Other
Intervention code [2] 257965 0
Prevention
Intervention code [3] 257966 0
Lifestyle
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262027 0
Blood pressure and heart rate were measured before, immediately after, 5 and 10 minutes after the 6 minute walk test.
Timepoint [1] 262027 0
At baseline and at 4, 8 and 12 weeks of training and at 4 weeks of detraining
Secondary outcome [1] 268984 0
Cardio-respiratory performance was evaluated using the 6 minute walk test.
Timepoint [1] 268984 0
At baseline and at 4, 8 and 12 weeks of training and at 4 weeks of detraining

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.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
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.
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 3158 0
Brazil
State/province [1] 3158 0

Funding & Sponsors
Funding source category [1] 258395 0
University
Name [1] 258395 0
Universidade Federal do Parana
Country [1] 258395 0
Brazil
Primary sponsor type
University
Name
Universidade Federal do Parana
Address
R. Jaguariaiva, 512 Matinhos Parana Brasil 83260-000
Country
Brazil
Secondary sponsor category [1] 257538 0
University
Name [1] 257538 0
Physiotherapy Clinic School of Universidade Federal do Parana
Address [1] 257538 0
R. Arthur Zanluti, 1402 Matinhos-PR Brasil 83260-000
Country [1] 257538 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260369 0
Human Research Ethics Committee of the Federal University of Parana Health Sciences
Ethics committee address [1] 260369 0
R. Padre Camargo, 280 - Alto da Gloria - Curitiba - Parana - 80060-240
Ethics committee country [1] 260369 0
Brazil
Date submitted for ethics approval [1] 260369 0
05/09/2008
Approval date [1] 260369 0
24/09/2008
Ethics approval number [1] 260369 0
CAAE-0057.0.091.000-08

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.
Trial website
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)
Public notes

Contacts
Principal investigator
Name 32132 0
Address 32132 0
Country 32132 0
Phone 32132 0
Fax 32132 0
Email 32132 0
Contact person for public queries
Name 15379 0
Rafaella Ribas Locks
Address 15379 0
R. Eduardo Carlos Pereira, 4021, apto 802 - Portao - Curitiba - Parana - 81020-770
Country 15379 0
Brazil
Phone 15379 0
55-41-96154487
Fax 15379 0
Email 15379 0
rafaellalocks@gmail.com
Contact person for scientific queries
Name 6307 0
Anna Raquel Silveira Gomes
Address 6307 0
R. Jaguariaiva, 512 - Matinhos - Parana - 83260-000
Country 6307 0
Brazil
Phone 6307 0
55-41-35118300
Fax 6307 0
Email 6307 0
annaraquelsg@gmail.com

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

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