Effectiveness and Safety of Physical Exercises in the Improvement of the Sleep Efficiency Regarding Rheumatoid Arthritis (SRA)
Physical exercise programs are effective and safe for the improvement of the sleep efficiency in patients with Rheumatoid Arthritis.
|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|
- 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.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||September 2014|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01919645
|Contact: Andrea H Kayo, PHD email@example.com|
|Contact: Virginia Trevisani, PHD MDfirstname.lastname@example.org|
|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|
|Principal Investigator:||Andrea H Kayo, PHD student||Federal University of São Paulo|