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

Arthritis, Rheumatoid Clinical Trial

— SRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919645
• Other study ID #: AHK2013
• Status: Completed
• Phase: N/A
• First received: August 3, 2013
• Last updated: August 31, 2016
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• Combined Training ( Strength + Aerobics)
Strength training performed using workout devices and aerobic training performed using stationary bicycle.

Locations

Country	Name	City	State
Brazil	Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of sleep through a polysomnogram exam.	Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.	at baseline and at end-week 16	No