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

Federal University of São Paulo

Status: Completed

Conditions: Arthritis, Rheumatoid

Treatments: Other: Combined Training ( Strength + Aerobics)

Study type: Interventional

Funder types: Other

Identifiers

NCT01919645

AHK2013

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups, including a placebo group

Combined Training Group

Experimental group

Description:

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.

Treatment:

Other: Combined Training ( Strength + Aerobics)

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Combined Training ( Strength + Aerobics)