SarcopeniaNCT02278731
Exercise Protocols in Postural Balance Of Elderly Women
A study testing training program in people with Sarcopenia, run by Universidade Estadual do PiauÍ.
Trial summary
To determine and compare the effects of a training program with Pilates and Facilitation Neuromuscular Proprioceptive on balance and function in elderly women. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jul 2014
- 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 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All the subjects were between 60 and 80 years old,
- sedentary and healthy
Who cannot join
- -Orthopedic, cardiovascular, vestibular, psychological, neurological or any other impairment that would not allow the execution of all study tasks
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- training program
- Keywords
- Physical activity, Rehabilitation, Older adults, Pilates, Proprioceptive neuromuscular facilitation
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The elderly in Control Group suffered no intervention and continued with their daily activities. |
| Pilates Group | Active comparator | 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. Receives: Other: training program |
| PNF Group | Active comparator | 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. Receives: Other: training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of the center of pressure of the body
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).
Measured: 1 month
Functional mobility on the Timed Up & Go test
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.
Measured: 1 month
Static and dynamic balance on the Berg Balance test
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do PiauÍ
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laiana Sepúlveda de Andrade Mesquita, Universidade Estadual do PiauÍ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278731
- Sponsor's protocol ID
- U1111-1162-4778
- Status last verified
- Oct 2014
- First submitted
- 22 Oct 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mesquita LS, de Carvalho FT, Freire LS, Neto OP, Zangaro RA. Effects of two exercise protocols on postural balance of elderly women: a randomized controlled trial. BMC Geriatr. 2015 Jun 2;15:61. doi: 10.1186/s12877-015-0059-3.
PubMed 26033080
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF TWO EXERCISE PROTOCOLS IN POSTURAL BALANCE OF ELDERLY WOMEN
- ClinicalTrials.gov ID
- NCT02278731
- Acronym / sponsor ID
- U1111-1162-4778
- Conditions
- Sarcopenia
- Keywords
- Physical activity, Rehabilitation, Older adults, Pilates, Proprioceptive neuromuscular facilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universidade Estadual do PiauÍUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Oct 2014 (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.
To determine and compare the effects of a training program with Pilates and Facilitation Neuromuscular Proprioceptive on balance and function in elderly women.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The elderly in Control Group suffered no intervention and continued with their daily activities. |
| Pilates Group | Active comparator | Other: training programPilates 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. |
| PNF Group | Active comparator | Other: training programPNF 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All the subjects were between 60 and 80 years old,
- sedentary and healthy
Key exclusion criteria (1 listed)
- -Orthopedic, cardiovascular, vestibular, psychological, neurological or any other impairment that would not allow the execution of all study tasks
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 |
|---|---|---|
| training programParticipants 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. | Other | PNF Group, Pilates Group |
Primary outcome
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).
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.
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.
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 30 Oct 2014.
- Derived from this study: PubMed 26033080Mesquita LS, de Carvalho FT, Freire LS, Neto OP, Zangaro RA. Effects of two exercise protocols on postural balance of elderly women: a randomized controlled trial. BMC Geriatr. 2015 Jun 2;15:61. doi: 10.1186/s12877-015-0059-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing training program in people with Sarcopenia, run by Universidade Estadual do PiauÍ.
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 2 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 30 Oct 2014. 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.
What does the primary outcome measure?
Displacement of the center of pressure of the body (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278731, which also lists 1 linked publication.
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 30 Oct 2014.