Exercise Therapy Program in Ankylosing Spondylitis Patients

• ClinicalTrials.gov Identifier: NCT01690273
• Recruitment Status: Completed
• First Posted: September 21, 2012
• Results First Posted: October 20, 2016
• Last Update Posted: October 20, 2016
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Andrea Lopes Gallinaro, University of Sao Paulo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ankylosing Spondylitis	Other: mobility exercise; Other: mobility and elastic resistance exercise	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Two Exercise Therapy Program With and Without Elastic Resistance in Ankylosing Spondylitis Patients
• Study Start Date: July 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
No Intervention: ankylosing spondylitis control; control group
Experimental: mobility exercise; mobility exercises	Other: mobility exercise; 30 minutes, twice a week
Experimental: mobility and elastic resistance exercise; AS patients was submitted to a program mobility exercise plus elastic resistance exercises	Other: mobility and elastic resistance exercise; 30 minutes, twice a week each exercises group. (total 1 hour)

Outcome Measures

Primary Outcome Measures :

1. FUNCTIONAL INDEX [ Time Frame: Baseline and 16 Weeks ]
   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.
2. Mobility Index [ Time Frame: Baseline and 16 weeks ]
   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)
3. Disease Activity Index [ Time Frame: Baseline and 16 Weeks ]
   BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)
4. Ankylosing Spondylitis Disease Activity Scale -Disease Activity [ Time Frame: Baseline and 16 Weeks ]
   Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD
5. Global Evaluation Self Reported [ Time Frame: Baseline and 16 Weeks ]
   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.

Secondary Outcome Measures :

1. Thoracolumbar Mobility [ Time Frame: Baseline and 16 Weeks ]
   Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation
2. Pain Scale [ Time Frame: 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.
3. Stiffness Scale [ Time Frame: Baseline and 16 Weeks ]
   Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.
4. Short Form-12 (PCS) [ Time Frame: Baseline and 16 Weeks ]
   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.
5. Short Form-12 (MCS) [ Time Frame: Baseline and 16 Weeks ]
   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.
6. MASES [ Time Frame: Baseline and 16 Weeks ]
   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
7. Chin-coronoid Distance [ Time Frame: Baseline and 16 Weeks ]
   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
8. Tragus-coronoid Distance [ Time Frame: Baseline and 16 Weeks ]
   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
9. Finger Floor Distance [ Time Frame: Baseline and 16 Weeks ]
   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
10. Chest Expansion [ Time Frame: Baseline and 16 Weeks ]
    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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Brazil

University of Sao Paulo

Sao Paulo, Brazil, 05403-010

Sponsors and Collaborators

University of Sao Paulo

Investigators

• Study Chair: Ana Lucia Pinto, Phd; University of Sao Paulo

More Information

Publications of Results:

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.

• Responsible Party: Andrea Lopes Gallinaro, MASTER, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01690273
• Other Study ID Numbers: 8206212
• First Posted: September 21, 2012
• Results First Posted: October 20, 2016
• Last Update Posted: October 20, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: paper is been written

Keywords provided by Andrea Lopes Gallinaro, University of Sao Paulo:

exercise; mobility; strengthening; physiotherapy

Additional relevant MeSH terms:

Spondylitis; Spondylitis, Ankylosing; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylarthropathies; Spondylarthritis; Ankylosis; Joint Diseases; Arthritis