NCT01586650

Brief Summary

This is a randomized controlled trial with blinded assessor on the effects of aerobic exercise (walking)in patients with Ankylosing Spondylitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

April 21, 2012

Last Update Submit

February 14, 2017

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitisaerobic exercise

Outcome Measures

Primary Outcomes (1)

  • Change in BASFI

    Bath Ankylosing Spondylitis Functional Index (BASFI) is a quaestionnaire with 10 questions about functional capacity validated to AS patients. Each question is answered with a visual analogue scale 0-10 cm. Zero means the best, and 10 the worst function.

    Baseline, after 6, 12 and 24 weeks.

Secondary Outcomes (7)

  • Change in BASDAI

    Baseline, after 6, 12 and 24 weeks.

  • Change in BASMI

    Baseline, after 6, 12 and 24 weeks.

  • Change in HAQ-S

    Baseline, after 6, 12 and 24 weeks.

  • Incremental cardiopulmonary exercise testing protocol by treadmill

    Baseline and after 12 weeks.

  • Levels of C reactive protein and erythrocyte rate sedimentation

    Baseline, after 6. 12 and 24 weeks

  • +2 more secondary outcomes

Study Arms (2)

Aerobic training

EXPERIMENTAL

The patients in this arm perform a 50-minute-walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.

Other: aerobic trainingOther: Stretching exercises

Stretching exercises

PLACEBO COMPARATOR

The control group perform global stretching exercises for approximately 20 minutes 3 times a week for 12 weeks.

Other: Stretching exercises

Interventions

aerobic trainingOTHER

The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.

Aerobic training
Stretching exercisesOTHER

Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.

Aerobic trainingStretching exercises

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Ankylosing Spondylitis according to New York modified criteria.
  • Stable drug treatment for at least 3 months
  • Sedentary for at least 3 months before randomization
  • Steinbrocker class I/II

You may not qualify if:

  • Uncontrolled Systemic Arterial Hypertension and Diabetes mellitus.
  • Ischemic heart disease
  • Clinically significant diseases
  • Orthopedic surgery, such as hip arthroplasty, in the last year.
  • Inability to walk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04039-002, Brazil

Location

Related Publications (1)

  • Braun J, van den Berg R, Baraliakos X, Boehm H, Burgos-Vargas R, Collantes-Estevez E, Dagfinrud H, Dijkmans B, Dougados M, Emery P, Geher P, Hammoudeh M, Inman RD, Jongkees M, Khan MA, Kiltz U, Kvien T, Leirisalo-Repo M, Maksymowych WP, Olivieri I, Pavelka K, Sieper J, Stanislawska-Biernat E, Wendling D, Ozgocmen S, van Drogen C, van Royen B, van der Heijde D. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis. 2011 Jun;70(6):896-904. doi: 10.1136/ard.2011.151027.

    PMID: 21540199BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jamil Natour, Prof, MD

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 21, 2012

First Posted

April 27, 2012

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

February 15, 2017

Record last verified: 2017-02

Locations

BR(1)