NCT01351311

Brief Summary

The aim of the present study is to assess the effectiveness of resistance training with swiss ball in the treatment of patients with ankylosing spondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 30, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

May 9, 2011

Last Update Submit

November 29, 2012

Conditions

Ankylosing Spondylitis

Keywords

treatmentexerciseresistance trainingswiss ballfunctional capacity

Outcome Measures

Primary Outcomes (1)

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    Functional capacity assessed by BASFI

    16 weeks

Secondary Outcomes (10)

  • LIKERT SCALE

    16 weeks

  • 1 REPETITION MAXIMUM TEST

    16 weeks

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    16 weeks

  • Bath Ankylosing Spondylitis Metrology Index (BASMI)

    16 weeks

  • erythrocyte sedimentation rate (ESR)

    16 weeks

  • +5 more secondary outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

Resistance exercise with swiss ball and drug treatment

Other: Exercise

Control Group

OTHER

Drug treatment

Other: Drug treatment

Interventions

ExerciseOTHER

Resistance Training exercise with swiss ball

Also known as: Experimental group
Exercise Group
Drug treatmentOTHER

Drug treatment

Also known as: Control group
Control Group

Eligibility Criteria

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

You may qualify if:

  • Patients with established diagnosis of AS steinbrocker functional class I-II
  • Basic medication stable for at least three months
  • Agreed to participate and signed term of informed consent

You may not qualify if:

  • Uncontrolled hypertension
  • Coronary artery disease
  • History of revascularization
  • History of syncope or arrhythmias induced by exercise
  • Decompensated diabetes mellitus
  • Severe psychiatric illness
  • Fibromyalgia
  • Another medical condition more disabling than AS
  • History of exercise regular (at least 30 minutes 2 times per week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcelo Cardoso de Souza

São Paulo, São Paulo, 04121001, Brazil

Location

Related Publications (2)

  • American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.

    PMID: 19204579BACKGROUND

  • Souza MC, Jennings F, Morimoto H, Natour J. Swiss ball exercises improve muscle strength and walking performance in ankylosing spondylitis: a randomized controlled trial. Rev Bras Reumatol Engl Ed. 2017 Jan-Feb;57(1):45-55. doi: 10.1016/j.rbre.2016.09.009. Epub 2016 Oct 20. English, Portuguese.

    PMID: 28137402DERIVED

MeSH Terms

Conditions

Spondylitis, AnkylosingMotor Activity

Interventions

ExerciseControl Groups

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Marcelo Souza, PT, MSc

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Fábio Jennings, MD, MSc

    Federal University of São Paulo

    STUDY DIRECTOR

  • Jamil Natour, MD, PHD

    Division of Rheumatology, Federal University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MsC

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 30, 2012

Record last verified: 2012-11

Locations

BR(1)