Exercise Protocols in Postural Balance Of Elderly Women

October 27, 2014 updated by: Laiana Sepúlveda de Andrade Mesquita, Universidade Estadual do PiauÍ

EFFECTS OF TWO EXERCISE PROTOCOLS IN POSTURAL BALANCE OF ELDERLY WOMEN

To determine and compare the effects of a training program with Pilates and Facilitation Neuromuscular Proprioceptive on balance and function in elderly women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Older women living in Teresina and participating in a local church project called "Pão dos Pobres" were randomly divided into three groups: Proprioceptive Neuromuscular Facilitation (PNFG), Pilates (PG) and Control(CG). Intervention: A training program (50 minutes session) was performed with the PNFG and the PG, 3 times a week, for 4 weeks. The elderly in CG suffered no intervention and continued with their daily activities. Main Outcome Measures: The stabilometric parameters, Berg Balance Scale score, functional reach test and Timed Up and Go test (TUG test) were measured before and one month after, in all participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All the subjects were between 60 and 80 years old,
  • sedentary and healthy

Exclusion Criteria:

-Orthopedic, cardiovascular, vestibular, psychological, neurological or any other impairment that would not allow the execution of all study tasks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
The elderly in Control Group suffered no intervention and continued with their daily activities.
Active Comparator: Pilates Group
Pilates group (PG), which underwent one-month (three times per week) training program with the Pilates method. This protocol consisted of Pilates exercises on the ground.Stretches were performed on upper trunk and lower limbs before the exercises. Subsequently, exercises that included the range of motion and strength of the upper limbs, trunk and lower limbs were performed, always associated with breathing and contraction of transversus abdominis muscles, in different positions, increasing repetitions and resistance in the weeks of the study, using the Swiss ball, thera-band and the magic circle.
Other: training program
Participants were randomly allocated to 1 of 3 groups: Pilates group (n=20), which underwent one-month (three times per week) training program with the Pilates method; PNF group (n=20), that underwent one-month (three times per week) training program using the PNF method; and Control group (n=18), that received no intervention during that one month and continued with their daily activities.
Active Comparator: PNF Group
PNF group that underwent one-month (three times per week) training program using the propriocptive neuromuscular facilitation method.The selected PNF diagonal patterns were chosen with all the basic procedures to the facilitation and according to three specific principles of PNF: rhythmic initiation, sustain and relax and reversal of antagonists. During the first week, one set of ten repetitions for each diagonal was performed; in the second week, two sets of ten repetitions and in the third and fourth weeks, three sets of ten repetitions were performed.
Other: training program
Participants were randomly allocated to 1 of 3 groups: Pilates group (n=20), which underwent one-month (three times per week) training program with the Pilates method; PNF group (n=20), that underwent one-month (three times per week) training program using the PNF method; and Control group (n=18), that received no intervention during that one month and continued with their daily activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Displacement of the center of pressure of the body
Time Frame: 1 month
Displacement of the center of pressure of the body was collected using an electronic baropodometer, composed by a force platform with 1600 sensors. The subjects were oriented to be in a standing position in the platform, barefoot, bipedal support and with feet hip width apart.The kinetic variables related to body balance analyzed were: total displacement oscillation (TDO), amplitude of displacement of the center of pressure antero-posterior (ACPap), amplitude of displacement of the center of pressure medio-lateral (ACPml), displacement area (AREA), antero-posterior average speed (AAS), medio-lateral average speed (MAS) and total average speed (TAS).
1 month
Functional mobility on the Timed Up & Go test
Time Frame: 1 month
The Timed Up & Go test (TUG) was applied to evaluate functional mobility involving speed, agility and dynamic balance of the elderly women, measuring the time in seconds spent by the volunteer to stand up from a chair (seat height 45 cm) without the help of arms, walk a three meters distance, turn around and return.
1 month
Static and dynamic balance on the Berg Balance test
Time Frame: 1 month
The Berg Balance Scale consists in 14 tasks, on a 5-point ordinal scale, ranging from 0 (unable to perform the task) to 5 (performs the task independently). Scores of the 14 tasks are summed into a total score, ranging from 0 to 56 points, the highest score being related to better performance and values lower or equal to 45 points being related to prediction of falls.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual do PiauÍ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1162-4778

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