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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01919645
Acronym
SRA
Enrollment
43
Registered
2013-08-09
Start date
2012-07-31
Completion date
2013-12-31
Last updated
2016-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis, Sleep Disorders, Polysomnography, Sleep Stages, Physical Exercise

Brief summary

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

Interventions

OTHERCombined Training ( Strength + Aerobics)

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

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement of sleep through a polysomnogram exam.at baseline and at end-week 16Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026