Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effects of Aerobic Training in Patients With Ankylosing Spondylitis

14. februar 2017 opdateret af: Martin F Simoes, MD, Federal University of São Paulo
This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Ankylosing Spondylitis (AS) is a systemic inflammatory disease that affects mainly the spine and compromises globally the physical capacity of the patients. Despite new advances in pharmacological therapy, physiotherapy and exercise remain essential in the treatment of AS. However, the literature lacks studies showing which types of exercises are more effective in patients with AS.

This is a randomized controlled trial with the objective is to evaluate the effects of aerobic training on functional capacity, mobility, disease activity, cardiopulmonary capacity and cytokine levels (TNF, IL10, IL6 and IL1) in patients with AS.

The duration of the trial is 24 weeks with the first 12 weeks reserved to exercise programs. The participants will be divided in two groups. The intervention group (IG) will perform walking for 50 minutes plus global stretching 3 times a week for 12 weeks. The control group (CG) will do only stretching exercises 3 times a week for 12 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Sao Paulo, Brasilien, 04039-002
        • Universidade Federal de Sao Paulo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of Ankylosing Spondylitis according to New York modified criteria.

    • Stable drug treatment for at least 3 months
    • Sedentary for at least 3 months before randomization
    • Steinbrocker class I/II

Exclusion Criteria:

  • Uncontrolled Systemic Arterial Hypertension and Diabetes mellitus.

    • Ischemic heart disease
    • Clinically significant diseases
    • Orthopedic surgery, such as hip arthroplasty, in the last year.
    • Inability to walk.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Aerobic training
The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
Andet: aerobic training
The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
Andet: Stretching exercises
Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
Placebo komparator: Stretching exercises
The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.
Andet: Stretching exercises
Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in BASFI
Tidsramme: Baseline, after 6, 12 and 24 weeks.
Bath Ankylosing Spondylitis Functional Index (BASFI) is a quaestionnaire with 10 questions about functional capacity validated to AS patients. Each question is answered with a visual analogue scale 0-10 cm. Zero means the best, and 10 the worst function.
Baseline, after 6, 12 and 24 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in BASDAI
Tidsramme: Baseline, after 6, 12 and 24 weeks.
Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) is a instrument with 6 questions about disease activity validated to AS patients. The questions comprise the following areas: back pain, peripheral pain, morning stifness, fatigue and enthesitis.
Baseline, after 6, 12 and 24 weeks.
Change in BASMI
Tidsramme: Baseline, after 6, 12 and 24 weeks.
Bath Ankylosing Spondylitis Mobility Index (BASMI) is an instrument that comprises 5 measures of mobility validated to AS patients. The measurements are: cervical rotation, lumbar flexion (Schober's test modified, intermalleolar distance, lumbar side flexion and tragus to wall. The total score is shown in a 0-10 cm visual analogue scale. The low scores represent better mobility.
Baseline, after 6, 12 and 24 weeks.
Change in HAQ-S
Tidsramme: Baseline, after 6, 12 and 24 weeks.
Health Assessment Questionnaire for Spondyloarthritis (HAQ-S)is a questionnaire with 10 domains about functional capacity validated to AS patients. The scores ranges from 0 to 3.
Baseline, after 6, 12 and 24 weeks.
Incremental cardiopulmonary exercise testing protocol by treadmill
Tidsramme: Baseline and after 12 weeks.
Incremental cardiopulmonary exercise testing protocol by treadmill is used to measure aerobic capacity of the patients.
Baseline and after 12 weeks.
Levels of C reactive protein and erythrocyte rate sedimentation
Tidsramme: Baseline, after 6. 12 and 24 weeks
CRP and ESR are laboratory methods to evaluate inflammatory response using blood sample.
Baseline, after 6. 12 and 24 weeks
Levels of cytokines- TNF, IL10, IL6 and IL1.
Tidsramme: Baseline and after 12 weeks.
Cytokines are substances that make part of inflammatory response. The most important cytokines- TNF alpha, IL10, IL6 and IL1 will be measured in serum samples.
Baseline and after 12 weeks.
Change in the Six minute walking test
Tidsramme: Baseline, after 6, 12 and 24 weeks.
The 6-minute walking test is a instrument to evaluate functional capacity. It is performed measuring the distance that the participant is able to walk during 6 minutes.
Baseline, after 6, 12 and 24 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federal University of São Paulo

Samarbejdspartnere

Fundação de Amparo à Pesquisa do Estado de São Paulo

Efterforskere

  • Studieleder: Jamil Natour, Prof, MD, Federal University of São Paulo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2011

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

21. april 2012

Først indsendt, der opfyldte QC-kriterier

25. april 2012

Først opslået (Skøn)

27. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1325/08

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ankyloserende spondylitis

Kliniske forsøg med aerobic training

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in France

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner