Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000895280
Ethics application status
Approved
Date submitted
24/08/2009
Date registered
14/10/2009
Date last updated
14/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an aerobic training program in elderly- a pilot study
Scientific title
Effect of an aerobic training program in metabolic, anthropometrics and physical condition parameters in elderly – a pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
abdominal obesity in the elderly 237385 0
body obesity in the elderly 243573 0
triglyceride levels in the elderly 243574 0
cholesterol levels in the elderly 243575 0
glucose levels in the elderly 243576 0
physical fitness in the elderly 243577 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239700 239700 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aerobic training consisted of a walking program with a frequency of three sessions per week for a period of 12 weeks. The sessions had a total duration of 30 minutes in the first six weeks, with an additional five minutes each week from week seven to 55 minutes a session that lasted until the end of training. During the training program, the target heart rate of each volunteer was monitored using a heart rate monitor (Polar, F4) and is the measure of individual control of the training that was provided for in accordance with age, with a gradual progression 65% to 75% of maximum heart rate predicted for age.
Intervention code [1] 237028 0
Rehabilitation
Comparator / control treatment
The volunteers remained for a period of six weeks in the control situation, in which they were instructed to maintain their daily living habits and avoid realization of prolonged or strenuous physical activities.
Control group
Active

Outcomes
Primary outcome [1] 240469 0
Primary Outcome: Changes in anthropometrics variables (body mass, body mass index, waist circumference and waist-hip ratio).
Measurements were measured using a scale with a stadiometer (Welmy). The volunteers were instructed to use the same clothing, remove their shoes before each measurement, look at the horizon and let the arms along the body. For hip circumference, the tape was passed, flush, around the waist in the region located between the last rib and the iliac crest, a region that was stripped during the measurement. For hip circumference, the tape was placed flush around the hip area of greatest diameter. The readings were taken immediately after a full expiration.
Timepoint [1] 240469 0
Timepoints: at baseline and at 6 and 12 weeks after intervention.
Primary outcome [2] 240655 0
Primary Outcome: Changes in total cholesterol levels.
We obtained blood samples pre-prandial (after fasting for 12 hours) in the morning, so the patients would arrive for collection. Puncture was performed on the index finger, after cleansing with alcohol, using a steel disposable lancet to collect approximately 20 microlitos of blood was placed directly on the reagent strips and inserted into the device (Accutrend Plus - GCTL)for reading each measure.
Timepoint [2] 240655 0
Timepoints: at baseline and at 6 and 12 weeks after intervention.
Primary outcome [3] 240656 0
Primary Outcome: Changes in triglyceride levels.
We obtained blood samples pre-prandial (after fasting for 12 hours) in the morning, so the patients would arrive for collection. Puncture was performed on the index finger, after cleansing with alcohol, using a steel disposable lancet to collect approximately 20 microlitos of blood was placed directly on the reagent strips and inserted into the device (Accutrend Plus - GCTL)for reading each measure.
Timepoint [3] 240656 0
Timepoints: at baseline and at 6 and 12 weeks after intervention.
Primary outcome [4] 240657 0
Primary Outcome: Changes in glucose levels.
We obtained blood samples pre-prandial (after fasting for 12 hours) in the morning, so the patients would arrive for collection. Puncture was performed on the index finger, after cleansing with alcohol, using a steel disposable lancet to collect approximately 20 microlitos of blood was placed directly on the reagent strips and inserted into the device (Accutrend Plus - GCTL)for reading each measure.
Timepoint [4] 240657 0
Timepoints: at baseline and at 6 and 12 weeks after intervention.
Primary outcome [5] 240658 0
Primary Outcome: Improves physical conditioning evidenced stimated Maximum Oxygen Consumption (stimated VO2Max) and the Total Exercise Time (ETT).
To determine the variables of physical performance used a progressive test on a treadmill (Imbramed) until fatigue which represented the time when the volunteer reported an exhaustive effort on the scale of perceived exertion (PSE). To this end, we used the Stanford Protocol, which consisted of ten stages, lasting 3 minutes each, constant speed of 4.8 km/h and slope of 0% in the first stage. After each stage, there was an increase of 2.5% gradient, and the slope at the tenth stage represented 22.5%. The VO2max was estimated from the rate of metabolic equivalent (MET) complete the last stage of the treadmill exercise performed by the volunteer, with 1 MET represents 3.5 mlO2/kg/min.
Timepoint [5] 240658 0
Timepoints: at baseline and at 6 and 12 weeks after intervention.
Secondary outcome [1] 257006 0
nil
Timepoint [1] 257006 0
nil

Eligibility
Key inclusion criteria
Age >= 60 years, has not been submitted to any surgical procedure in the lower limbs, has not been submitted to physiotherapeutic treatment or rehabilitation of any procedure in the last three months, not to make use of any aid to locomotion, cognitive conditions present minimum, not make changes and skin diseases and none were taking Beta-blockers.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
We excluded the elderly who had orthopedic diseases, neurological, respiratory or cardiac acute that could interfere with implementation of the proposed exercises, urinary or fecal incontinence, vestibular disorders, 10% or more of absence in the intervention and those who performed regular physical activity three times or more per week with duration greater than or equal to 30 minutes.

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment outside Australia
Country [1] 1922 0
Brazil
State/province [1] 1922 0

Funding & Sponsors
Funding source category [1] 237446 0
Government body
Name [1] 237446 0
Foundation of Support to the Research of the State of Minas Gerais (FAPEMIG)
Country [1] 237446 0
Brazil
Funding source category [2] 237447 0
Government body
Name [2] 237447 0
National Advice of Scientific and Technological Development (CNPq)
Country [2] 237447 0
Brazil
Primary sponsor type
University
Name
Federal University of the Jequitinhonha and Mucuri Valleys
Address
Street da Gloria, 187- Centro
CEP 39100-000
Diamantina/MG
Country
Brazil
Secondary sponsor category [1] 237011 0
Other Collaborative groups
Name [1] 237011 0
Physiology Laboratory Exercise (LAFIEX)
Address [1] 237011 0
Rodovia MGT 367 Km 583, number 5000
Alto da Jacuba
CEP 39100-000
Diamantina/MG
Country [1] 237011 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243671 0
Comite de Etica em Pesquisa da Universidade Federal dos Vales do Jequitinhonha e Mucuri -UFVJM
Ethics committee address [1] 243671 0
Ethics committee country [1] 243671 0
Brazil
Date submitted for ethics approval [1] 243671 0
Approval date [1] 243671 0
17/11/2008
Ethics approval number [1] 243671 0
057/2008

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

Contacts
Principal investigator
Name 29979 0
Address 29979 0
Country 29979 0
Phone 29979 0
Fax 29979 0
Email 29979 0
Contact person for public queries
Name 13226 0
Ana Cristina Rodrigues Lacerda
Address 13226 0
Departamento de Fisioterapia, UFVJM, Rua da Gloria, numero 187, Centro, 39100-000, Diamantina, Minas Gerais
Country 13226 0
Brazil
Phone 13226 0
+55 (038) 35311811
Fax 13226 0
+55 (038) 35313808
Email 13226 0
[email protected]
Contact person for scientific queries
Name 4154 0
Ana Cristina Rodrigues Lacerda
Address 4154 0
Departamento de Fisioterapia, UFVJM, Rua da Gloria, numero 187, Centro, 39100-000, Diamantina, Minas Gerais
Country 4154 0
Brazil
Phone 4154 0
+55 (038) 35311811
Fax 4154 0
+55 (038) 35313808
Email 4154 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.