AgingNCT03526757
Effects of Pilates Standing Exercises on Walking Mobility and Postural Balance
A study testing Standing Pilates protocol and Standard Pilates protocol in people with Aging and Mobility Limitation, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Importance: Aging is characterized by numerous molecular, physiological, functional, motor and psychological changes, such as loss of postural balance and reduced muscle mass/strength. Such modifications often lead to reduced physical-functional capacity in the elderly and increased risk of falls. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Aging, Mobility Limitation, Postural Balance
- What is being tested?
- Standing Pilates protocol and Standard Pilates protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2018to 30 Jul 2019
- 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
- Sedentary for at least 6 months
- To be available for one hour, twice a week, on two different working days to perform the proposed exercises.
- To show preserved cognitive function, according to the mini-mental state examination criteria;
- Be able to come and go on their own to the training location (Physiotherapy Laboratory at PUCRS).
Who cannot join
- Clinical contraindications for performing physical exercises;
- To show severe heart, orthopedic, neurological or other diseases/conditions that may affect the outcome measures;
- Practicing physical exercises outside the study protocol;
- Absence of independent gait.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90619-900
About this study
Official title: The Effects of Pilates Standing Exercises on Walking Mobility and Postural Balance in Sedentary Older Adults: a Randomized Clinical Trial
Importance: Aging is characterized by numerous molecular, physiological, functional, motor and psychological changes, such as loss of postural balance and reduced muscle mass/strength. Such modifications often lead to reduced physical-functional capacity in the elderly and increased risk of falls. Currently, physical exercise is widely used to improve physical performance and reduce, at least in part, postural instabilities and the risk of falls. In this context, the Pilates method may be a good strategy to improve body balance, muscle strength and, potentially, the perception of quality of life in this population, depending how the exercises are performed. This study seeks to assess whether practicing Pilates exercises in orthostatic position results in differential effects on walking mobility and postural balance in healthy elderly women when compared to the standard sequence in the Pilates method, which involves less time performing exercise in the orthostatic position. The study hypothesis is that a higher relative volume of Pilates exercises performed in the orthostatic position can promote greater benefits in terms of walking mobility and postural balance compared to the standard Pilates protocol in the elderly.
Read the detailed description
Importance: Aging is characterized by numerous molecular, physiological, functional, motor and psychological changes, such as loss of postural balance and reduced muscle mass/strength. Such modifications often lead to reduced physical-functional capacity in the elderly and increased risk of falls. Currently, physical exercise is widely used to improve physical performance and reduce, at least in part, postural instabilities and the risk of falls. In this context, the Pilates method may be a good strategy to improve body balance, muscle strength and, potentially, the perception of quality of life in this population, depending how the exercises are performed.
Objective: To evaluate whether practicing Pilates exercises in orthostatic position results in differential effects on walking mobility and postural balance in healthy elderly women when compared to the standard sequence in the Pilates method, which involves less time performing exercise in the orthostatic position.
Design, Methods and Participants: Clinical, single blind controlled and randomized trial. 36 previously sedentary elderly women will be included in the study and sign a Free and Informed Consent Term (TCLE). The Pilates protocols will be administered over 12 weeks on a bi-weekly scheme, and each session will last approximately 50 minutes. The subjects who agree to participate will be evaluated at baseline and immediately post-intervention.
Intervention: Subjects will be randomized to participate in the experimental group (Pilates exercises with emphasis on orthostatic posture) or control group (Pilates exercises practiced following traditional sequence of postures).
Main Outcomes and Measurements: The main outcome of the study will be walking mobility and postural balance, assessed using the Timed Up and Go test (single "motor" and dual task "cognitive-motor" tests), BERG Balance Scale, Functional Reach Test, and ABC Balance Confidence Scale).
Expected results: The experimental group is expected to perform better in terms of walking mobility and body balance, since hypothetically, a higher relative volume of orthostatic exercises would be more adequate for training anticipatory postural adjustments when compared to the traditional Pilates postural sequence.
- Conditions
- Aging, Mobility Limitation, Postural Balance
- Being tested
- Standing Pilates protocol, Standard Pilates protocol
- Keywords
- Postural balance, Pilates method, Elderly
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standing Pilates protocolOther
Also called Pilates exercises in orthostatic position
Subjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks. The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position.
Standard Pilates protocolOther
Also called Standard Pilates exercises
Subjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks. The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session.
| Study group | Role | What they receive |
|---|---|---|
| Standing Pilates protocol | Experimental | Subjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks. The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position. Receives: Other: Standing Pilates protocol |
| Standard Pilates protocol | Active comparator | Subjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks. The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session. Receives: Other: Standard Pilates protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking mobility (Timed Up and Go Test)
Walking mobility will be assessed using the Timed Up and Go tests (single and dual task - cognitive/motor). It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
Measured: Post-intervention (change after 12 weeks of training)
Secondary outcomes (4)
Postural balance - Functional Reach Test
Postural balance will be assessed using the Functional Reach Test. The FRT is a quick single-task dynamic test defined as the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the standing position.
Measured: Post-intervention (change after 12 weeks of training)
Postural balance - BERG Balance scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Measured: Post-intervention (change after 12 weeks of training)
Activities-specific Balance Confidence (ABC) Scale.
For each assessed activity, the subjects indicate their level of confidence in doing the activity without losing your balance or becoming unsteady from choosing one of the percentage points on the scale from 0% to 100%. If subjects do not currently do the activity in question, they should imagine how confident they would be if had to do the activity. If they normally use a walking aid to do the activity or hold onto someone, subjects should rate their confidence as if they were using these supports.
Measured: Post-intervention (change after 12 weeks of training)
Quality of life (36-Item Short Form Health Survey - SF-36)
Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of eight scaled scores (vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; and mental health.), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Post-intervention (change after 12 weeks of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Mar 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects will be allocated to one of two groups: intervention protocol (high volume of standing Pilates exercises) or control protocol (standard sequence of Pilates exercises).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Sponsor
- Investigators
- Régis G Mestriner, PhD, Study chair, Pontifícia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526757
- Sponsor's protocol ID
- 8185
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will make all efforts to publish and make individual participant data (IPD) available, according to the requirements of the scientific journal that accepts this research.
Publications
Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.
PubMed 21975148Walowska J, Bolach B, Bolach E. The influence of Pilates exercises on body balance in the standing position of hearing impaired people. Disabil Rehabil. 2018 Dec;40(25):3061-3069. doi: 10.1080/09638288.2017.1370731. Epub 2017 Nov 13.
PubMed 29132250Bueno de Souza RO, Marcon LF, Arruda ASF, Pontes Junior FL, Melo RC. Effects of Mat Pilates on Physical Functional Performance of Older Adults: A Meta-analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2018 Jun;97(6):414-425. doi: 10.1097/PHM.0000000000000883.
PubMed 29283899Oliveira LC, Oliveira RG, Pires-Oliveira DAA. Pilates increases the isokinetic muscular strength of the knee extensors and flexors in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):815-822. doi: 10.1016/j.jbmt.2017.01.006. Epub 2017 Jan 8.
PubMed 29037633Bertoli J, Biduski GM, de la Rocha Freitas C. Six weeks of Mat Pilates training are enough to improve functional capacity in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):1003-1008. doi: 10.1016/j.jbmt.2016.12.001. Epub 2016 Dec 3.
PubMed 29037615Teixeira de Carvalho F, de Andrade Mesquita LS, Pereira R, Neto OP, Amaro Zangaro R. Pilates and Proprioceptive Neuromuscular Facilitation Methods Induce Similar Strength Gains but Different Neuromuscular Adaptations in Elderly Women. Exp Aging Res. 2017 Oct-Dec;43(5):440-452. doi: 10.1080/0361073X.2017.1369624. Epub 2017 Sep 26.
PubMed 28949820Vieira ND, Testa D, Ruas PC, Salvini TF, Catai AM, de Melo RC. The effects of 12 weeks Pilates-inspired exercise training on functional performance in older women: A randomized clinical trial. J Bodyw Mov Ther. 2017 Apr;21(2):251-258. doi: 10.1016/j.jbmt.2016.06.010. Epub 2016 Jun 21.
PubMed 28532866Greblo Jurakic Z, Krizanic V, Sarabon N, Markovic G. Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial. Aging Clin Exp Res. 2017 Dec;29(6):1295-1298. doi: 10.1007/s40520-017-0740-9. Epub 2017 Mar 1.
PubMed 28251569
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pilates Standing Exercises on Walking Mobility and Postural Balance in Sedentary Older Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03526757
- Acronym / sponsor ID
- 8185
- Conditions
- Aging, Mobility Limitation, Postural Balance
- Keywords
- Postural balance, Pilates method, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 16 May 2018 (actual)
- 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.
Importance: Aging is characterized by numerous molecular, physiological, functional, motor and psychological changes, such as loss of postural balance and reduced muscle mass/strength. Such modifications often lead to reduced physical-functional capacity in the elderly and increased risk of falls. Currently, physical exercise is widely used to improve physical performance and reduce, at least in part, postural instabilities and the risk of falls. In this context, the Pilates method may be a good strategy to improve body balance, muscle strength and, potentially, the perception of quality of life in this population, depending how the exercises are performed. This study seeks to assess whether practicing Pilates exercises in orthostatic position results in differential effects on walking mobility and postural balance in healthy elderly women when compared to the standard sequence in the Pilates method, which involves less time performing exercise in the orthostatic position. The study hypothesis is that a higher relative volume of Pilates exercises performed in the orthostatic position can promote greater benefits in terms of walking mobility and postural balance compared to the standard Pilates protocol in the elderly.
Detailed description
Importance: Aging is characterized by numerous molecular, physiological, functional, motor and psychological changes, such as loss of postural balance and reduced muscle mass/strength. Such modifications often lead to reduced physical-functional capacity in the elderly and increased risk of falls. Currently, physical exercise is widely used to improve physical performance and reduce, at least in part, postural instabilities and the risk of falls. In this context, the Pilates method may be a good strategy to improve body balance, muscle strength and, potentially, the perception of quality of life in this population, depending how the exercises are performed.
Objective: To evaluate whether practicing Pilates exercises in orthostatic position results in differential effects on walking mobility and postural balance in healthy elderly women when compared to the standard sequence in the Pilates method, which involves less time performing exercise in the orthostatic position.
Design, Methods and Participants: Clinical, single blind controlled and randomized trial. 36 previously sedentary elderly women will be included in the study and sign a Free and Informed Consent Term (TCLE). The Pilates protocols will be administered over 12 weeks on a bi-weekly scheme, and each session will last approximately 50 minutes. The subjects who agree to participate will be evaluated at baseline and immediately post-intervention.
Intervention: Subjects will be randomized to participate in the experimental group (Pilates exercises with emphasis on orthostatic posture) or control group (Pilates exercises practiced following traditional sequence of postures).
Main Outcomes and Measurements: The main outcome of the study will be walking mobility and postural balance, assessed using the Timed Up and Go test (single "motor" and dual task "cognitive-motor" tests), BERG Balance Scale, Functional Reach Test, and ABC Balance Confidence Scale).
Expected results: The experimental group is expected to perform better in terms of walking mobility and body balance, since hypothetically, a higher relative volume of orthostatic exercises would be more adequate for training anticipatory postural adjustments when compared to the traditional Pilates postural sequence.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The subjects will be allocated to one of two groups: intervention protocol (high volume of standing Pilates exercises) or control protocol (standard sequence of Pilates exercises).
| Arm | Type | Receives |
|---|---|---|
| Standing Pilates protocol | Experimental | Other: Standing Pilates protocolSubjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks. The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position. |
| Standard Pilates protocol | Active comparator | Other: Standard Pilates protocolSubjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks. The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session. |
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)
- Sedentary for at least 6 months
- To be available for one hour, twice a week, on two different working days to perform the proposed exercises.
- To show preserved cognitive function, according to the mini-mental state examination criteria;
- Be able to come and go on their own to the training location (Physiotherapy Laboratory at PUCRS).
Key exclusion criteria (4 listed)
- Clinical contraindications for performing physical exercises;
- To show severe heart, orthopedic, neurological or other diseases/conditions that may affect the outcome measures;
- Practicing physical exercises outside the study protocol;
- Absence of independent gait.
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 |
|---|---|---|
| Standing Pilates protocolAlso: Pilates exercises in orthostatic positionSubjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks. The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position. | Other | Standing Pilates protocol |
| Standard Pilates protocolAlso: Standard Pilates exercisesSubjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks. The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session. | Other | Standard Pilates protocol |
Primary outcome
Walking mobility (Timed Up and Go Test)
Time frame: Post-intervention (change after 12 weeks of training)
Walking mobility will be assessed using the Timed Up and Go tests (single and dual task - cognitive/motor). It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
4 secondary outcomes
Postural balance - Functional Reach Test
Time frame: Post-intervention (change after 12 weeks of training)
Postural balance - BERG Balance scale
Time frame: Post-intervention (change after 12 weeks of training)
Activities-specific Balance Confidence (ABC) Scale.
Time frame: Post-intervention (change after 12 weeks of training)
Quality of life (36-Item Short Form Health Survey - SF-36)
Time frame: Post-intervention (change after 12 weeks of training)
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 Sep 2021.
- Background: PubMed 21975148Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.
- Background: PubMed 29132250Walowska J, Bolach B, Bolach E. The influence of Pilates exercises on body balance in the standing position of hearing impaired people. Disabil Rehabil. 2018 Dec;40(25):3061-3069. doi: 10.1080/09638288.2017.1370731. Epub 2017 Nov 13.
- Background: PubMed 29283899Bueno de Souza RO, Marcon LF, Arruda ASF, Pontes Junior FL, Melo RC. Effects of Mat Pilates on Physical Functional Performance of Older Adults: A Meta-analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2018 Jun;97(6):414-425. doi: 10.1097/PHM.0000000000000883.
- Background: PubMed 29037633Oliveira LC, Oliveira RG, Pires-Oliveira DAA. Pilates increases the isokinetic muscular strength of the knee extensors and flexors in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):815-822. doi: 10.1016/j.jbmt.2017.01.006. Epub 2017 Jan 8.
- Background: PubMed 29037615Bertoli J, Biduski GM, de la Rocha Freitas C. Six weeks of Mat Pilates training are enough to improve functional capacity in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):1003-1008. doi: 10.1016/j.jbmt.2016.12.001. Epub 2016 Dec 3.
- Background: PubMed 28949820Teixeira de Carvalho F, de Andrade Mesquita LS, Pereira R, Neto OP, Amaro Zangaro R. Pilates and Proprioceptive Neuromuscular Facilitation Methods Induce Similar Strength Gains but Different Neuromuscular Adaptations in Elderly Women. Exp Aging Res. 2017 Oct-Dec;43(5):440-452. doi: 10.1080/0361073X.2017.1369624. Epub 2017 Sep 26.
- Background: PubMed 28532866Vieira ND, Testa D, Ruas PC, Salvini TF, Catai AM, de Melo RC. The effects of 12 weeks Pilates-inspired exercise training on functional performance in older women: A randomized clinical trial. J Bodyw Mov Ther. 2017 Apr;21(2):251-258. doi: 10.1016/j.jbmt.2016.06.010. Epub 2016 Jun 21.
- Background: PubMed 28251569Greblo Jurakic Z, Krizanic V, Sarabon N, Markovic G. Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial. Aging Clin Exp Res. 2017 Dec;29(6):1295-1298. doi: 10.1007/s40520-017-0740-9. Epub 2017 Mar 1.
- Individual participant dataSharing planned: Undecided. We will make all efforts to publish and make individual participant data (IPD) available, according to the requirements of the scientific journal that accepts this research.
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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.
Régis G Mestriner, PhD study chair
Pontifícia Universidade Católica do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standing Pilates protocol and Standard Pilates protocol in people with Aging and Mobility Limitation, run by Pontificia Universidade Católica do Rio Grande do Sul 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 4 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 Sep 2021. 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?
Walking mobility (Timed Up and Go Test) (time frame: Post-intervention (change after 12 weeks of training)). 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 NCT03526757, which also lists 8 linked publications.
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 Sep 2021; AzTrials last refreshed its copy on 6 Nov 2026.