|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
3 December 2012 |
|
Main ID: |
NCT01351311 |
|
Date of registration:
|
09/05/2011 |
|
Primary sponsor: |
|
|
Public title:
|
Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis
|
|
Scientific title:
|
Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis |
|
Date of first enrolment:
|
March 2011 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01351311 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Jamil Natour, MD, PHD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Division of Rheumatology, Federal University of Sao Paulo |
|
|
Name:
|
Fábio Jennings, MD, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Federal University of Sao Paulo |
|
|
Name:
|
Marcelo Souza, PT, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Federal University of Sao Paulo |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with established diagnosis of AS steinbrocker functional class I-II
- Basic medication stable for at least three months
- Agreed to participate and signed term of informed consent
Exclusion Criteria:
- Uncontrolled hypertension
- Coronary artery disease
- History of revascularization
- History of syncope or arrhythmias induced by exercise
- Decompensated diabetes mellitus
- Severe psychiatric illness
- Fibromyalgia
- Another medical condition more disabling than AS
- History of exercise regular (at least 30 minutes 2 times per week)
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Ankylosing Spondylitis
|
|
Intervention(s)
|
|
Other: Drug treatment
|
|
Other: Exercise
|
|
Primary Outcome(s)
|
|
Bath Ankylosing Spondylitis Functional Index (BASFI)
[Time Frame: 16 weeks]
|
|
Secondary Outcome(s)
|
|
1 REPETITION MAXIMUM TEST
[Time Frame: 16 weeks]
|
|
6-MINUTE WALK TEST
[Time Frame: 16 weeks]
|
|
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
[Time Frame: 16 weeks]
|
|
Bath Ankylosing Spondylitis Metrology Index (BASMI)
[Time Frame: 16 weeks]
|
|
erythrocyte sedimentation rate (ESR)
[Time Frame: 16 weeks]
|
|
Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire
[Time Frame: 16 weeks]
|
|
LIKERT SCALE
[Time Frame: 16 weeks]
|
|
QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED
[Time Frame: 16 weeks]
|
|
Short form-36 (SF-36)
[Time Frame: 16 weeks]
|
|
TIME UP AND GO TEST
[Time Frame: 16 weeks]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|