- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02278731
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
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
Interventional
Enrollment (Actual)
58
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
October 22, 2014
First Submitted That Met QC Criteria
October 27, 2014
First Posted (Estimate)
October 30, 2014
Study Record Updates
Last Update Posted (Estimate)
October 30, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1162-4778
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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