Hiking Improves the Functional Autonomy

Tracking Information
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; (submitted: September 21, 2009)	10 meters [ Time Frame: seconds ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: September 21, 2009)	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.
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: Warm up: Duration five to ten minutes of articular exercises of upper body, neck, trunk and lower body.; Development: twenty to thirty minutes of hiking in a natural method.; To came back to calmness: three to five minutes of sitting elongated and/or laying down: neck, upper and lower body and trunk; using the changed method by segment. The activity of intervention was oriented at a controlled environment as the surface (plain and does not glide) and markation of the walked distances (field jogging does not count - 260 meters) where the training was controlled by the time of hiking, according to Norms of the American College Sport of Medicine and of the fifth Brazilian Norm of arterial Hypertension, that has the requirement of a minimum frequency of three times per week with the duration of twenty and thirty minutes; adequate to have a good mean to physiological adaptations in etary group. 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.
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
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.
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 21, 2009)	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: Registered in a program of family health (PFH),; Age above 60 years,; Hypertension,; Not be trainee of physical activity and those who were at clinical conditions that composed the research. Exclusion Criteria: Old women with any kind of infirmity that could interferes in study or that becomes a factor of prevention of the tests that were designed for functional anatomy.
Sex/Gender	Sexes Eligible for Study: Female
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	Principal Investigator: Functional Autonomy older women Universidade Camilo Castelo Branco
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