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

August 31, 2016 updated by: Andrea Kayo, Federal University of São Paulo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04026-001
        • Centro de Estudos em Psicobiologia e Exercício (CEPE) da Associação Fundo de Incentivo a Pesquisa (AFIP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline and at end-week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 3, 2013

First Submitted That Met QC Criteria

August 7, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

August 31, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHK2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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