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CompletedNCT01351311Updated Nov 30, 2012

Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

An interventional study of Exercise and Drug treatment in Ankylosing Spondylitis, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-11-30.

Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

A randomized, controlled, single-blind, prospective trial being conducted involving 54 patients with ankylosing spondylitis, selected from outpatient clinics - UNIFESP. They will be randomized in intervention group (n = 27) conduct training for muscle strengthening with the aid of the Swiss ball and in the control group (n = 27) did not undergo any intervention. Eight exercises will be conducted with intent to engage all muscle groups.

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • treatment
  • exercise
  • resistance training
  • swiss ball
  • functional capacity
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 60 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Exercise Group

    Resistance exercise with swiss ball and drug treatment

    Other: Exercise

  • Other
    Control Group

    Drug treatment

    Other: Drug treatment

Interventions

  • OtherExercise

    Resistance Training exercise with swiss ball

    Also known as: Experimental group

  • OtherDrug treatment

    Drug treatment

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Functional capacity assessed by BASFI

    Time frame: 16 weeks

Secondary outcomes

  1. LIKERT SCALE

    Likert scale by patients.

    Time frame: 16 weeks

  2. 1 REPETITION MAXIMUM TEST

    muscle strength by testing an repetition maximum (1 RM)

    Time frame: 16 weeks

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    disease activity by BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index)

    Time frame: 16 weeks

  4. Bath Ankylosing Spondylitis Metrology Index (BASMI)

    spinal mobility by BASMI

    Time frame: 16 weeks

  5. erythrocyte sedimentation rate (ESR)

    Time frame: 16 weeks

  6. 6-MINUTE WALK TEST

    Time frame: 16 weeks

  7. TIME UP AND GO TEST

    Time frame: 16 weeks

  8. Short form-36 (SF-36)

    quality of life by SF-36

    Time frame: 16 weeks

  9. QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED

    Time frame: 16 weeks

  10. Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire

    Function

    Time frame: 16 weeks

07

Study locations

1 site
  • Marcelo Cardoso de Souza
    Sao Paulo, 04121001, Brazil
08

References and documents

Publications

  • 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. PubMed 19204579 ↗
  • 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. PubMed 28137402 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01351311
Lead sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Marcelo Cardoso de Souza (MsC, Federal University of São Paulo) — Principal investigator
First posted
May 10, 2011
Start date
Mar 2011
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Nov 30, 2012

Study contacts

Marcelo Souza, PT, MSc
principal investigator · Federal University of São Paulo
Fábio Jennings, MD, MSc
study director · Federal University of São Paulo
Jamil Natour, MD, PHD
study chair · Division of Rheumatology, Federal University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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