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OpenTrials
Completed

NCT Number: NCT01919645

Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality. Regarding Rheumatoid Arthritis

Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Behavior Connective Tissue Diseases Immune System Diseases Joint Diseases Mental Disorders Motor Activity Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases Sleep Wake Disorders

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)

São Paulo, 04026-001, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women ages 35-65 years diagnosed with Rheumatoid Arthritis according with the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR)Criteria; Pittsburgh Sleep Quality Index ≥ 5; electrocardiogram test (ECG) at rest and at regular effort.

Exclusion criteria

  • Patients with joint restrictions due to disease.
  • Other rheumatoid-associated diseases (Fibromyalgia) with the exception of Osteoarthritis of low degree.
  • Those who are uncontrollably hypertense, diabetic, with thyroidopathy and cardiorespiratory diseases which stop them from practicing exercises.
  • Class II obesity (IMC ≥ 35 Kg/m2).
  • Cognitive deficits.
  • Depression.
  • Patients not following the study rules such as exercise hours and / or time for the proposed program.
  • Current physical exercise practitioner.
  • Those undergoing medication treatment which would interfere sleep.
  • Night shift workers who disrespect regular working schedule.

Treatment and study plan

Combined Training ( Strength + Aerobics)

Other

Strength training performed using workout devices and aerobic training performed using stationary bicycle.

Primary outcomes

  1. Improvement of sleep through a polysomnogram exam.

    Time frame: at baseline and at end-week 16

    Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Quality in Women With Rheumatoid Arthritis: A Randomized Clinical Trial Study

Acronym: SRA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2013
Registry last updated
Sep 2, 2016

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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