Hiking Improves the Functional Autonomy
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ClinicalTrials.gov Identifier: NCT00981734 |
Recruitment Status
:
Completed
First Posted
: September 22, 2009
Last Update Posted
: September 22, 2009
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Tracking Information | ||||
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First Submitted Date ICMJE | September 14, 2009 | |||
First Posted Date ICMJE | September 22, 2009 | |||
Last Update Posted Date | September 22, 2009 | |||
Study Start Date ICMJE | September 2008 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
10 meters [ Time Frame: seconds ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
meters [ Time Frame: seconds ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Hiking Improves the Functional Autonomy | |||
Official Title ICMJE | Effects of a Hiking Study About the Functional Autonomy Levels in Old Women Analyzed by the Family Health Program | |||
Brief Summary | This is an experimental research study. The subjects were randomized into two groups: Experimental group (EG; n=58, age: 67 ± 6 old) and Control group (CG; n=40; age: 70 ± 6 old). All were physically active without strictly obeying in regularity of the program of physical activity. The functional autonomy was evaluated by the amount of tests of Group Development of Latin American Maturity (GDLAM). It consists of hiking ten meters (C10m); standing up from the sitting position (SSP); to stand up from the ventral decubitus position (SSPVD); to stand up from a chair and be able to walk around your home (SCWH); and to be able to wear and remove a t-shirt (DTS). These tests have showed similar results in indice of GDLAM (IG). The intervention took place three times a week, with intensity that has varied between fifty five to seventy five per cent of the frequency maximum from heart. |
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Detailed Description | In the physical evaluation, the participants were asked that they bathe with clothes (swimsuit, trunks) to measure the body composition, stature and IMC. All of the results were recorded in elaborated cards by the researcher. The participants were physically evaluated through systemic observation during 16 weeks. The first collection of data occurred in the first week of April and the second collection occurred in the first week of August, 2009 during the morning. A weighing machine with the unit of Filizola registered to INMETRO (precision of 100 grams) was used to evaluate body composition. Stature was measured through the use of a Estadiometer registered to INMETRO (precision of 1 mm). In order to evaluate the functional autonomy, GDLAM (Group Development of Latin American Maturity) created by Dantas and Vale, was used. It consists of hiking ten meters (C10m); standing up from the sitting position (SSP); to stand up from the ventral decubitus position (SSPVD); to stand up from a chair and be able to walk around your home (SCWH); and to be able to wear and remove a t-shirt (DTS). Everybody was measured in seconds and consists of a score called the General Indice of the GDLAM (IG). The results of reference for classification of the functional autonomy level were the same for IG and its components and GDLAM. The intervention took place three times per week (Monday, Wednesday, Friday) from 5 PM to 5:45 PM. Intensity varied between 50% and 75% of the frequency maximum from heart (FMH) obtained by the equation: FMH = 220 - age. The FMH was controlled by the standardization of the heart frequency (HF) from the carotid at six seconds and then multiplied by ten. This HF WAS measured by the participants themselves. They received training and orientations to learn the right method. All the participants had their HF measured by monitors, at least one time per session. Therefore after the self-standardization, with the aim to confirm the identified results by the older women. The moment of standardization of the HF varied due to the voice of the responsible teacher or asked by the monitor close to the old woman. The sessions were spread out in the subsequent ways:
Statistic Evaluation: Descriptive Statistics were used with average, error-standard, median, standard deviation, minimum and maximum and absolute delt. The normality of the sample was evaluated by the test by Shapiro-Wilk (GC) and by Kolmogorov Smirnov (GE). To analyze the answer variables, comparisons were made between groups, t-student test couplet or by Wilcoxon, when appropriate (homogeneous or heterogenous distributions of the data, respectively). To make evaluations between groups the parametric test by ANOVA was used in two ways, followed by Post Hoc de Scheffe. The study used the level of p < 0.05 to test the statistical significance. The results were evaluated by Excel and the Statistical Package for the Social Science® (SPSS), version 14.0. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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Condition ICMJE | Aging | |||
Intervention ICMJE | Other: Hiking
Three times by a week, thirty minutes, controlling heart frequency between fifty five per cent and seventy five per cent.
Other Name: Funcionality, life style. |
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
98 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | February 2009 | |||
Actual Primary Completion Date | January 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 60 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00981734 | |||
Other Study ID Numbers ICMJE | 0042/2008 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Rubens Ceasr Lucena da Cunha, Universidade Castelo Branco | |||
Study Sponsor ICMJE | Universidade Camilo Castelo Branco | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Universidade Camilo Castelo Branco | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |