Clinical trial NCT01690273: Exercise Therapy Program in Ankylosing Spondylitis Patients
Official title: Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: exercise
mobility
strengthening
physiotherapy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: FUNCTIONAL INDEX
timeFrame: Baseline and 16 Weeks
measure: Mobility Index
timeFrame: Baseline and 16 weeks
measure: Disease Activity Index
timeFrame: Baseline and 16 Weeks
measure: Ankylosing Spondylitis Disease Activity Scale -Disease Activity
timeFrame: Baseline and 16 Weeks
measure: Global Evaluation Self Reported
timeFrame: Baseline and 16 Weeks
Secondary outcomes:
measure: Thoracolumbar Mobility
timeFrame: Baseline and 16 Weeks
measure: Pain Scale
timeFrame: Baseline and 16 Weeks
measure: Stiffness Scale
timeFrame: Baseline and 16 Weeks
measure: Short Form-12 (PCS)
timeFrame: Baseline and 16 Weeks
measure: Short Form-12 (MCS)
timeFrame: Baseline and 16 Weeks
measure: MASES
timeFrame: Baseline and 16 Weeks
measure: Chin-coronoid Distance
timeFrame: Baseline and 16 Weeks
measure: Tragus-coronoid Distance
timeFrame: Baseline and 16 Weeks
measure: Finger Floor Distance
timeFrame: Baseline and 16 Weeks
measure: Chest Expansion
timeFrame: Baseline and 16 Weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Ana Lucia Pinto, Phd
role: STUDY_CHAIR
References:
citation: Yigit S, Sahin Z, Demir SE, Aytac DH. Home-based exercise therapy in ankylosing spondylitis: short-term prospective study in patients receiving tumor necrosis factor alpha inhibitors. Rheumatol Int. 2013 Jan;33(1):71-7. doi: 10.1007/s00296-011-2344-6. Epub 2012 Jan 5.