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

Not Applicable

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Other: Combined Training ( Strength + Aerobics)

• Registration Number: NCT01919645
• Lead Sponsor: Federal University of São Paulo

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-09
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Combined Training ( Strength + Aerobics)	The control group patients did not perform any intervention through physical exercises. They were oriented on Sleep Hygiene and were followed during the study. They were asked to come to the following visits (at weeks 8 and 16) and to 2 additional visits to get and then return the actigraph. During this period, they were followed through phone calls once a month and were asked for sleep hygiene and were reminded of their assessment dates.
Combined Training Group	Combined Training ( Strength + Aerobics)	Combined Training - (strength + aerobics). A combined training (CT)is performed, having aerobics exercises (AE)using a stationary bicycle and strength training in workout devices. The strength training (ST) will be performed by isotonic exercises recruiting the main muscle groups. They exercises are: Chest Press, Leg Press, Vertical Traction, Leg Extension and Abdominal Crunch.

Primary Outcome Measures

Name	Time	Method
Improvement of sleep through a polysomnogram exam.	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.

Trial Locations

Locations (1)

Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP); 🇧🇷 Sao Paulo, Brazil