Osteoarthritis, KneeNCT03321084
Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
A study testing MatPliates in people with Osteoarthritis, Knee, run by Maria das Graças Rodrigues de Araújo at 1 site in Brazil.
Trial summary
Introduction: The osteoarthrosis is incurable, one of the most incapacitating disease around the world and your prevalence is increasing every year. The main consequences of this disease is pain and loss of functionality as a result of biomechanical limitations coming from articular inflammation. Read more about this study
- Who is it for?
- Ages 60 to 69 years, women only
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- MatPliates
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2017to 20 Mar 2018
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral osteoarthritis
- Body mass index (BMI) between 25 and 34,9 (WHO, 2000)
- Mini mental state examination score, with cutoff score of 18 (illiterate) and 24 (literate) (BRUCKI et al. 2003; LOURENÇO e VERAS, 2006)
- Unassisted gait (no wheelchair, no walking stick, no crutches or no walker)
- No history of neurologic disease
- No other physical activity
- Never practiced Pilates
Who cannot join
- Change in habitual drug's program during the study
- Join in other physical activity during the study
- Refuse to wear suitable clothing
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
Recife, Pernambuco, 50670-901
Maria das Graças Araujo, PhD, +558121268939, mgrodriguesaraujo@hotmail.com
About this study
Introduction: The osteoarthrosis is incurable, one of the most incapacitating disease around the world and your prevalence is increasing every year. The main consequences of this disease is pain and loss of functionality as a result of biomechanical limitations coming from articular inflammation. Among the variability of therapeutic resources, we propose MatPilates like a no drug intervention, that probably will contribute for a decrease in the symptoms of this disease.
Objective: It is hypothesized that MatPilates is a method capable of decrease pain and increase functionality in elderly woman with osteoarthrosis.
Methods: This study is a randomized double blind clinical trial, in which the volunteer need be in between 60 and 69 years old. Will be formed of two groups: MatPilates Group (MG) and Control Group (CG), and the ideal "n" will be calculated in a pilot study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- MatPliates, Control
- Keywords
- Osteoarthrosis, Exercise Movement Techniques, Pilates, Elderly, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatPliatesOther
Also called Experimental
The MatPilates program was specialized developed for this trial, in which all exercises belong to contemporaneous Pilates style. Each session has 60 minutes of duration, divided in three blocs (stretching, exercise and relaxation), with mean of 10, 40 and 10 minutes respectively (VIEIRA et al., 2016). Each exercise will be performed in one series of 10 to 15 repetitions and will be modified accordingly the patient need.
ControlOther
Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
| Study group | Role | What they receive |
|---|---|---|
| MatPilates | Experimental | In the beginning was nominated Contrology, but today is known as Pilates. Created by Joseph Humbertus Pilates. This technique is based on respiration, balance, flexibility, proprioception and muscular strength. One of the main work is on the power house (core), biomechanical axis of the body, composed of muscles: rectus abdominis, paravertebral, multifidus, diaphragm, and those of the perineal center. Receives: Other: MatPliates |
| Control | Other | It continues in your daily life with phone monitoring. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Measured: 7 weeks.
Secondary outcomes (6)
Pain
Visual analog scale.
Measured: 7 weeks.
Pain
Lequesne Index.
Measured: 7 weeks.
Functionality.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Measured: 7 weeks.
Functionality.
Lequesne Index.
Measured: 7 weeks.
Stiffness.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Measured: 7 weeks.
Balance.
Timed and Up Go Test (TUG)
Measured: 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start20 Apr 2017
- Primary completion20 Apr 2017
- Study completion20 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Model description
- Two groups: a MatPilates group (MG) and a Control group (CG).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria das Graças Rodrigues de Araújo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321084
- Sponsor's protocol ID
- MatPilates and Ostheoarthritis
- Other IDs
- Feedback N. 2.019.484
- Status last verified
- Feb 2018
- First submitted
- 14 Sep 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
- ClinicalTrials.gov ID
- NCT03321084
- Acronym / sponsor ID
- MatPilates and Ostheoarthritis
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthrosis, Exercise Movement Techniques, Pilates, Elderly, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maria das Graças Rodrigues de AraújoUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Mar 2018 (estimated)
- First posted
- 25 Oct 2017 (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.
Introduction: The osteoarthrosis is incurable, one of the most incapacitating disease around the world and your prevalence is increasing every year. The main consequences of this disease is pain and loss of functionality as a result of biomechanical limitations coming from articular inflammation. Among the variability of therapeutic resources, we propose MatPilates like a no drug intervention, that probably will contribute for a decrease in the symptoms of this disease.
Objective: It is hypothesized that MatPilates is a method capable of decrease pain and increase functionality in elderly woman with osteoarthrosis.
Methods: This study is a randomized double blind clinical trial, in which the volunteer need be in between 60 and 69 years old. Will be formed of two groups: MatPilates Group (MG) and Control Group (CG), and the ideal "n" will be calculated in a pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: a MatPilates group (MG) and a Control group (CG).
| Arm | Type | Receives |
|---|---|---|
| MatPilates | Experimental | Other: MatPliatesIn the beginning was nominated Contrology, but today is known as Pilates. Created by Joseph Humbertus Pilates. This technique is based on respiration, balance, flexibility, proprioception and muscular strength. One of the main work is on the power house (core), biomechanical axis of the body, composed of muscles: rectus abdominis, paravertebral, multifidus, diaphragm, and those of the perineal center. |
| Control | Other | Other: ControlIt continues in your daily life with phone monitoring. |
Who may qualify
- Ages
- 60 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Bilateral osteoarthritis
- Body mass index (BMI) between 25 and 34,9 (WHO, 2000)
- Mini mental state examination score, with cutoff score of 18 (illiterate) and 24 (literate) (BRUCKI et al. 2003; LOURENÇO e VERAS, 2006)
- Unassisted gait (no wheelchair, no walking stick, no crutches or no walker)
- No history of neurologic disease
Key exclusion criteria (3 listed)
- Change in habitual drug's program during the study
- Join in other physical activity during the study
- Refuse to wear suitable clothing
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 |
|---|---|---|
| MatPliatesAlso: ExperimentalThe MatPilates program was specialized developed for this trial, in which all exercises belong to contemporaneous Pilates style. Each session has 60 minutes of duration, divided in three blocs (stretching, exercise and relaxation), with mean of 10, 40 and 10 minutes respectively (VIEIRA et al., 2016). Each exercise will be performed in one series of 10 to 15 repetitions and will be modified accordingly the patient need. | Other | MatPilates |
| ControlWill not be submitted to any physical intervention. It continues in your daily life with only phone monitoring. | Other | Control |
Primary outcome
Pain.
Time frame: 7 weeks.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
6 secondary outcomes
Pain
Time frame: 7 weeks.
Pain
Time frame: 7 weeks.
Functionality.
Time frame: 7 weeks.
Functionality.
Time frame: 7 weeks.
Stiffness.
Time frame: 7 weeks.
Balance.
Time frame: 7 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
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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.
Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
Recife, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MatPliates in people with Osteoarthritis, Knee, run by Maria das Graças Rodrigues de Araújo 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain. (time frame: 7 weeks.). It is what the study was designed to measure, not a finding.
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 5 Feb 2018.