- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01690273
Exercise Therapy Program in Ankylosing Spondylitis Patients
27 augusti 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
55
Fas
- Inte tillämpbar
Kontakter och platser
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Studieorter
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Sao Paulo, Brasilien, 05403-010
- University of Sao Paulo
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: ankylosing spondylitis control
control group
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Experimentell: mobility exercise
mobility exercises
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30 minutes, twice a week
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
FUNCTIONAL INDEX
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Thoracolumbar Mobility
Tidsram: 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
Tidsram: Baseline and 16 Weeks
|
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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Ana Lucia Pinto, Phd, University of Sao Paulo
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2012
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 november 2014
Studieregistreringsdatum
Först inskickad
18 september 2012
Först inskickad som uppfyllde QC-kriterierna
20 september 2012
Första postat (Uppskatta)
21 september 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 oktober 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 8206212
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
paper is been written
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