- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03321084
Effects of MatPilates in Pain and Functionality in Elderly Woman With Osteoarthritis.
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.
Studieoversigt
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Pernambuco
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Recife, Pernambuco, Brasilien, 50670-901
- Rekruttering
- Laboratory of Kinesiotherapy and Manual Therapeutic Resources, Department of Physical Therapy, Federal University of Pernambuco (UFPE)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Change in habitual drug's program during the study
- Join in other physical activity during the study
- Refuse to wear suitable clothing
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: MatPilates
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.
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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.
Andre navne:
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Andet: Control
It continues in your daily life with phone monitoring.
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Will not be submitted to any physical intervention.
It continues in your daily life with only phone monitoring.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain.
Tidsramme: 7 weeks.
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
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7 weeks.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain
Tidsramme: 7 weeks.
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Visual analog scale.
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7 weeks.
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Pain
Tidsramme: 7 weeks.
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Lequesne Index.
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7 weeks.
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Functionality.
Tidsramme: 7 weeks.
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
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7 weeks.
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Functionality.
Tidsramme: 7 weeks.
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Lequesne Index.
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7 weeks.
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Stiffness.
Tidsramme: 7 weeks.
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
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7 weeks.
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Balance.
Tidsramme: 7 weeks.
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Timed and Up Go Test (TUG)
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7 weeks.
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MatPilates and Ostheoarthritis
- Feedback N. 2.019.484 (Anden identifikator: UFPE CAAE N. 63530416.1.0000.5208)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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