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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Federal University of São Paulo
Sponsor:
Information provided by (Responsible Party):
Andrea Kayo, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01919645
First received: August 3, 2013
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Arthritis, Rheumatoid
Other: Combined Training ( Strength + Aerobics)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Efficiency in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial Study

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Improvement of sleep through a polysomnogram exam. [ Time Frame: at baseline and at end-week 16 ] [ Designated as safety issue: No ]
    Evaluation of N3 stage of the sleep through a polysomnogram before and after 16 weeks of supervised exercises.


Estimated Enrollment: 31
Study Start Date: June 2012
Estimated Study Completion Date: September 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919645

Contacts
Contact: Andrea H Kayo, PHD student 55-11-23861977 ahkayo@uol.com.br
Contact: Virginia Trevisani, PHD MD 55-11-55752970 vmoca@uol.com.br

Locations
Brazil
Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP) Recruiting
Sao Paulo, Brazil, 04026-001
Sub-Investigator: Eduardo A Silva, PT         
Sub-Investigator: Andressa S Mello, PHD PT         
Sub-Investigator: Sebastiao J Gavea, PT         
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Andrea H Kayo, PHD student Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Andrea Kayo, Doctorate Student, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01919645     History of Changes
Other Study ID Numbers: AHK2013
Study First Received: August 3, 2013
Last Updated: August 7, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Rheumatoid Arthritis
Sleep Disorders
Polysomnography
Sleep Stages
Physical Exercise

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014