AgingNCT00981734
Hiking Improves the Functional Autonomy
A study testing Hiking in people with Aging, run by Universidade Camilo Castelo Branco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Aging
- What is being tested?
- Hiking
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2008to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Hiking Study About the Functional Autonomy Levels in Old Women Analyzed by the Family Health Program
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Hiking
- Keywords
- Aging, functionality, life style, To have more than sixty years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HikingOther
Also called Funcionality, life style.
Three times by a week, thirty minutes, controlling heart frequency between fifty five per cent and seventy five per cent.
What is being measured
The primary outcome is the main question the study is designed to answer.
10 meters
Measured: seconds
Secondary outcomes (1)
meters
Measured: seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Camilo Castelo Branco
- Sponsor type
- University, hospital or other
- Investigators
- Functional Autonomy older women, Principal investigator, Universidade Camilo Castelo Branco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981734
- Sponsor's protocol ID
- 0042/2008
- Status last verified
- Sep 2009
- First submitted
- 14 Sep 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hiking Study About the Functional Autonomy Levels in Old Women Analyzed by the Family Health Program
- ClinicalTrials.gov ID
- NCT00981734
- Acronym / sponsor ID
- 0042/2008
- Conditions
- Aging
- Keywords
- Aging, functionality, life style, To have more than sixty years
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Universidade Camilo Castelo BrancoUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HikingAlso: Funcionality, life style.Three times by a week, thirty minutes, controlling heart frequency between fifty five per cent and seventy five per cent. | Other | – |
Primary outcome
10 meters
Time frame: seconds
1 secondary outcome
meters
Time frame: seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Functional Autonomy older women principal investigator
Universidade Camilo Castelo Branco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hiking in people with Aging, run by Universidade Camilo Castelo Branco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 meters (time frame: seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009; AzTrials last refreshed its copy on 4 Nov 2026.