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

• ClinicalTrials.gov Identifier: NCT01919645
• Recruitment Status: Completed
• First Posted: August 9, 2013
• Last Update Posted: September 2, 2016
• Sponsor: Federal University of São Paulo
• Information provided by (Responsible Party): Andrea Kayo, Federal University of São Paulo

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Arthritis, Rheumatoid	Other: Combined Training ( Strength + Aerobics)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: July 2012
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Combined Training Group; 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.	Other: Combined Training ( Strength + Aerobics); Strength training performed using workout devices and aerobic training performed using stationary bicycle.
Placebo Comparator: Control Group; 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.	Other: Combined Training ( Strength + Aerobics); Strength training performed using workout devices and aerobic training performed using stationary bicycle.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Brazil

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

Sao Paulo, Brazil, 04026-001

Sponsors and Collaborators

Federal University of São Paulo

Investigators

• Principal Investigator: Andrea H Kayo, PHD student; Federal University of São Paulo

More Information

• Responsible Party: Andrea Kayo, PhD Student, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT01919645
• Other Study ID Numbers: AHK2013
• First Posted: August 9, 2013
• Last Update Posted: September 2, 2016
• Last Verified: August 2016

Keywords provided by Andrea Kayo, Federal University of São Paulo:

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

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases