- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01690273
Exercise Therapy Program in Ankylosing Spondylitis Patients
27. august 2016 opdateret af: Andrea Lopes Gallinaro, University of Sao Paulo
Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients
Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore axial mobility, but there are no data regarding a specific rehabilitation program that includes flexibility alone and its association with resistance exercises in AS patients with stable disease activity.
So, we assessed the effects of two exercise programs in terms of mobility, functional capacity, quality of life and disease activity in AS patients.
Methods.
Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI) <4 were included.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The AS patients were randomly assigned into three groups, to receive a mobility exercise program (M) or mobility plus elastic resistance exercise program (M+R) or no exercise (C).
The exercises group sessions were conducted twice per week for 16 weeks.
This supervised program comprised 30 minutes of outdoor stretching and mobility exercises for the spine and limbs (M).
After the flexibility program, M+R group carry out more 30 minutes of elastic resistance exercises.
The mobility, disease activity and functional parameters were evaluated at baseline and after 16 weeks, with the evaluator blinded to the treatment group.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
55
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sao Paulo, Brasilien, 05403-010
- University of Sao Paulo
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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
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ankylosing spondylitis patient
- Basdai index lower than 4
- Physical inactive
- Functional class I to III
Exclusion Criteria:
- Fibromyalgia
- Cardiovascular disease
- Pain Visual Analogue Scale ("VAS") over 8
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: ankylosing spondylitis control
control group
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Eksperimentel: mobility exercise
mobility exercises
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30 minutes, twice a week
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Eksperimentel: mobility and elastic resistance exercise
AS patients was submitted to a program mobility exercise plus elastic resistance exercises
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30 minutes, twice a week each exercises group.
(total 1 hour)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
FUNCTIONAL INDEX
Tidsramme: Baseline and 16 Weeks
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BASFI - Bath ankylosing spondylitis functional index.
A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.
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Baseline and 16 Weeks
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Mobility Index
Tidsramme: Baseline and 16 weeks
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Bath ankylosing spondylitis motion index.
A mean of five mobility measures committed by Ankylosing Spondylitis disease.
Higher results means higher limitations in mobility (units of measure from 0 to 10)
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Baseline and 16 weeks
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Disease Activity Index
Tidsramme: Baseline and 16 Weeks
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BASDAI - Bath ankylosing spondylitis disease activity index.
Scale from 0 to 6. Higher scores means worst disease activity.
Numbers are expressed in average (SD)
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Baseline and 16 Weeks
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Ankylosing Spondylitis Disease Activity Scale -Disease Activity
Tidsramme: Baseline and 16 Weeks
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Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity.
Data are expressed by means and SD
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Baseline and 16 Weeks
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Global Evaluation Self Reported
Tidsramme: Baseline and 16 Weeks
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Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation.
Expressed by means and standard deviation.
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Baseline and 16 Weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Thoracolumbar Mobility
Tidsramme: Baseline and 16 Weeks
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Thoracolumbar rotation Pavelka.
Measured with a tape in centimeters.
Higher number means better thoracolumbar rotation
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Baseline and 16 Weeks
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Pain Scale
Tidsramme: Baseline and 16 Weeks
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Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain.
Data was expressed by means and standard deviation.
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Baseline and 16 Weeks
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Stiffness Scale
Tidsramme: Baseline and 16 Weeks
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Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness.
Data are expressed by mean and SD.
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Baseline and 16 Weeks
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Short Form-12 (PCS)
Tidsramme: Baseline and 16 Weeks
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Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale.
Data are expressed by mean and SD.
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Baseline and 16 Weeks
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Short Form-12 (MCS)
Tidsramme: Baseline and 16 Weeks
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Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health).
Data are expressed by mean and SD.
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Baseline and 16 Weeks
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MASES
Tidsramme: Baseline and 16 Weeks
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Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13.
Where 0 is no painful point reported and 13 is all tender points reported as painful.
Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Chin-coronoid Distance
Tidsramme: Baseline and 16 Weeks
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lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters.
Highest score means better lateral rotation mobility.
Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Tragus-coronoid Distance
Tidsramme: Baseline and 16 Weeks
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lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters.
Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Finger Floor Distance
Tidsramme: Baseline and 16 Weeks
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Distance between third finger of the hand and the floor while in lumbar flexion.
It was measured with a tape in centimeters.
Highest score means better torso flexion mobility.
Data are expressed by means and standard deviation
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Baseline and 16 Weeks
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Chest Expansion
Tidsramme: Baseline and 16 Weeks
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Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling.
Highest score means better chest expansion.
Data are expressed by means and standard deviation.
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Baseline and 16 Weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Ana Lucia Pinto, Phd, University of Sao 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.
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 2012
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. november 2014
Datoer for studieregistrering
Først indsendt
18. september 2012
Først indsendt, der opfyldte QC-kriterier
20. september 2012
Først opslået (Skøn)
21. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. oktober 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 8206212
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
paper is been written
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