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Completed

NCT Number: NCT01351311

Resistance Training Exercise Using the Swiss Ball in Ankylosing Spondylitis

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.

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Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Behavior Bone Diseases Joint Diseases Motor Activity Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marcelo Cardoso de Souza

São Paulo, 04121001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Exercise

Other

Resistance Training exercise with swiss ball

Other names: Experimental group

Drug treatment

Other

Drug treatment

Other names: Control group

Primary outcomes

  1. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: 16 weeks

    Functional capacity assessed by BASFI

Secondary outcomes

  1. LIKERT SCALE

    Time frame: 16 weeks

    Likert scale by patients.

  2. 1 REPETITION MAXIMUM TEST

    Time frame: 16 weeks

    muscle strength by testing an repetition maximum (1 RM)

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: 16 weeks

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

  4. Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Time frame: 16 weeks

    spinal mobility by BASMI

  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)

    Time frame: 16 weeks

    quality of life by SF-36

  9. QUANTITY OF ANALGESICS AND ANTI-INFLAMATORY USED

    Time frame: 16 weeks

  10. Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire

    Time frame: 16 weeks

    Function

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Assessment of Effectiveness of Resistance Training Exercise Using the Swiss Ball in Patients With Ankylosing Spondylitis

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 10, 2011
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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