AgingNCT00906711
Analysis of Balance in the Aging Process
An observational study of Aging, run by Universidade de Franca.
Trial summary
Introduction: While growing older, it is possible to notice a decrease in the functional and physiological reserves in the organism which impairs the the abilities in the elderly in doing some tasks. A simple balance becomes a challenge. Objective: To evaluate the functional balance in the aging process. Read more about this study
- Who is it for?
- Ages 10 to 85 years
- Conditions the study is for
- Aging
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Oct 2008
- Phase
- Observational
- 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 10 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The participants were selected in dependency of Unifran (University of France) and the homes of the neighborhood. The choice of groups was based according to the degree of functionality and independence in order to analyze the lack of balance in the process of aging.
Who may be able to join
- Absence of the basic pathology that interferes directly in the balance
Who cannot join
- Neurological changes
- Cognitive impairment
- Orthopedic injury
- Use of orthoses for lower limb
- Obesity
- Exercise frequently (more than twice a week)
- The bearer of any commitment to stay in their standing position
About this study
Introduction: While growing older, it is possible to notice a decrease in the functional and physiological reserves in the organism which impairs the the abilities in the elderly in doing some tasks. A simple balance becomes a challenge.
Objective: To evaluate the functional balance in the aging process.
Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.
Read the detailed description
48 individuals of both sexes and aged between 10 and 85 years were chosen. These individuals were divided according to age, into four groups (each group containing 12 individuals, 6 men and 6 women): Group I (G1): 10 - 18, Group II (G2): 20 - 35; Group III (G3): 45 - 60, Group IV (G4): 65 - 85.
The instruments used for assessment of the balance were: (1) Berg Scale - consists of 14 items with common activities of daily life, with progressive degree of difficulty (2) Assessment of Gait and Balance for Performance Oriented (POMA), consists of a protocol that evaluates the static and dynamic balance, with operations similar to the activities of daily living, (3) Test Support Unipodal; (4) adapted Functional Reach Test, which assesses the stability in the standing position, (5) Test and Romberg Romberg's test Romberg-Barré or sensitized conducted in stable and unstable soil, and all positions were first with open eyes and then with closed eyes. The duration of each exposure was 30 seconds, with different positioning of the feet.
- Conditions
- Aging
- Keywords
- Aging, Postural Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | (G1): 10 - 18 years old | |
| Group II | (G2): 20 - 35 years old | |
| Group III | (G3): 45 - 60 years old | |
| Group IV | (G4): 65 - 85 years old |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startFeb 2008
- Primary completionAug 2008
- Study completionOct 2008
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
- Observational
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Franca
- Sponsor type
- University, hospital or other
- Investigators
- Lislei Patrizzi, Study director, Universidade de Franca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906711
- Sponsor's protocol ID
- 0081/08
- Status last verified
- May 2009
- First submitted
- 19 May 2009
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Balance in the Aging Process
- ClinicalTrials.gov ID
- NCT00906711
- Acronym / sponsor ID
- 0081/08
- Conditions
- Aging
- Keywords
- Aging, Postural Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universidade de FrancaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 May 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.
Introduction: While growing older, it is possible to notice a decrease in the functional and physiological reserves in the organism which impairs the the abilities in the elderly in doing some tasks. A simple balance becomes a challenge.
Objective: To evaluate the functional balance in the aging process.
Methods: The group was formed by 48 people from 10 to 85 years old. The evaluation instruments are the Berg Balance Scale (BBS), the Performance Oriented Mobility Assessment (POMA), the Unipodal Support Test, the Functional Reach Test and the Romberg's Test.
Detailed description
48 individuals of both sexes and aged between 10 and 85 years were chosen. These individuals were divided according to age, into four groups (each group containing 12 individuals, 6 men and 6 women): Group I (G1): 10 - 18, Group II (G2): 20 - 35; Group III (G3): 45 - 60, Group IV (G4): 65 - 85.
The instruments used for assessment of the balance were: (1) Berg Scale - consists of 14 items with common activities of daily life, with progressive degree of difficulty (2) Assessment of Gait and Balance for Performance Oriented (POMA), consists of a protocol that evaluates the static and dynamic balance, with operations similar to the activities of daily living, (3) Test Support Unipodal; (4) adapted Functional Reach Test, which assesses the stability in the standing position, (5) Test and Romberg Romberg's test Romberg-Barré or sensitized conducted in stable and unstable soil, and all positions were first with open eyes and then with closed eyes. The duration of each exposure was 30 seconds, with different positioning of the feet.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –(G1): 10 - 18 years old |
| Group II | – | –(G2): 20 - 35 years old |
| Group III | – | –(G3): 45 - 60 years old |
| Group IV | – | –(G4): 65 - 85 years old |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants were selected in dependency of Unifran (University of France) and the homes of the neighborhood. The choice of groups was based according to the degree of functionality and independence in order to analyze the lack of balance in the process of aging.
Key inclusion criteria (1 listed)
- Absence of the basic pathology that interferes directly in the balance
Key exclusion criteria (7 listed)
- Neurological changes
- Cognitive impairment
- Orthopedic injury
- Use of orthoses for lower limb
- Obesity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 May 2009.
Related trials for Aging
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Plant-based Diet in Older People: What Consequences for Muscle Health?
Aging
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.
Lislei Patrizzi study director
Universidade de Franca
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Universidade de Franca.
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 1 inclusion and 7 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 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
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 21 May 2009.