STRETCHING IN ANKYLOSING SPONDYLITIS

Ankylosing Spondylitis Clinical Trial

Official title:

BENEFITIAL EFFECTS OF A STRETCHING EXERCISE PROGRAM FOR PATIENTS WITH ANKYLOSING SPONDYLITIS - A RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690273
• Other study ID #: 8206212
• Status: Completed
• Phase: N/A
• First received: September 18, 2012
• Last updated: February 12, 2014
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of stretching exercise in patients with ankylosing spondylitis at quality of life, functional capacity in patients with BASDAI lower than 4.Evaluate 40 patients with the diagnose of ankylosing spondylitis according to the criteria of the American College of rheumatology provenient from FMUSP at Clinical Hospital of São Paulo.

Description:

The evaluation complies BASFI, BASDAI, BASMI,BAS-G, ASQOL, SF 12,MASES, finger to floor distance, intermaleolar distance, lateral rotation of head, lateral flexion of the head, stiffness VAS, chest expasibility, Pavelka evaluation. All patients are allocatted randomly into 2 groups. One control with no exercise or group 1 with stretching exercise ( 30 minutes).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Ankylosing spondylitis patient

• Basdai index lower than 4

• Physical inactive

• Functional class I to III

Exclusion Criteria:

• Fibromyalgia

• Cardiovascular disease

• Pain VAS over 8

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• stretching exercise
30 minutes, twice a week

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient evaluation quality of life	BAS-G, ASQOL, SF 12	sixteen weeks	Yes
Other	flexibility	FINGER TO FLOOR DISTANCE, intermaleolar distance,head lateral rotation , head lateral flexion, chest expansibility, Pavelka toracolumbar rotation.	sixteen weeks	Yes
Primary	FUNCTIONAL INDEX	BASFI - Bath ankylosyng spondylitis functional index	sixteen weeks	Yes
Secondary	BASMI	Bath ankylosing spondylitis motion index	sixteen weeks	Yes