Exercise Therapy Program in Ankylosing Spondylitis Patients

NCT01690273 | Completed Results

• 1 other identifier: 8206212
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Keywords

exercise; mobility; strengthening; physiotherapy

Outcome Measures

Primary Outcomes (5)

• FUNCTIONAL INDEX

  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.

  Baseline and 16 Weeks

• Mobility Index

  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)

  Baseline and 16 weeks

• Disease Activity Index

  BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)

  Baseline and 16 Weeks

• Ankylosing Spondylitis Disease Activity Scale -Disease Activity

  Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD

  Baseline and 16 Weeks

• Global Evaluation Self Reported

  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.

  Baseline and 16 Weeks

Secondary Outcomes (10)

• Thoracolumbar Mobility

  Baseline and 16 Weeks

• Pain Scale

  Baseline and 16 Weeks

• Stiffness Scale

  Baseline and 16 Weeks

• Short Form-12 (PCS)

  Baseline and 16 Weeks

• Short Form-12 (MCS)

  Baseline and 16 Weeks

Study Arms (3)

ankylosing spondylitis control

NO INTERVENTION

control group

mobility exercise

EXPERIMENTAL

mobility exercises

Other: mobility exercise

mobility and elastic resistance exercise

EXPERIMENTAL

AS patients was submitted to a program mobility exercise plus elastic resistance exercises

Other: mobility and elastic resistance exercise

Interventions

mobility exercise OTHER

30 minutes, twice a week

mobility exercise

mobility and elastic resistance exercise OTHER

30 minutes, twice a week each exercises group. (total 1 hour)

mobility and elastic resistance exercise

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ankylosing spondylitis patient
• Basdai index lower than 4
• Physical inactive
• Functional class I to III

You may not qualify if:

• Fibromyalgia
• Cardiovascular disease
• Pain Visual Analogue Scale ("VAS") over 8

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22218641 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing; Motor Activity

Interventions

Range of Motion, Articular

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Behavior

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Andrea Lopes Gallinaro; Researcher
• Organization: Universidade Sao Paulo

algallinaro@gmail.com

55112601

Study Officials

• Ana Lucia Pinto, Phd

  University of Sao Paulo

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MASTER

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 21, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: November 1, 2014
• Last Updated: October 20, 2016
• Results First Posted: October 20, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)