Aerobic Exercise in Primary Sjögren's Syndrome (AEPSS)
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|ClinicalTrials.gov Identifier: NCT02370225|
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sjogren's Syndrome||Other: aerobic exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Aerobic Exercise on Fatigue in Women With Primary Sjögren's Syndrome: Randomized Controlled Trial|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||March 2016|
Experimental: aerobic exercise
Subjects were submitted to a supervised walking, 3 times a week for 16 weeks.
Other: aerobic exercise
Each training session was preceded by a warm-up period, where patients were instructed to walk freely and slowly for 5 minutes, followed by 20 to 50 minutes of effective walking when they were instructed to maintain their paces to achieve the target heart rate and ending by a cold-up period for 5 minutes (similar to warm-up period).
The exercise prescription was based on the heart rate at the anaerobic threshold determined at the initial assessment. The increment of intensity exercise was based on time: 30 in the first 2 weeks, adding 5 minutes per week until eighth week, completing 60 minutes, which remains until the end.
No Intervention: no exercise
Subjects randomized to control group did not participate of the walking exercise initially, but after completing 16 weeks they were invited to participate of the training group.
- Change from baseline in fatigue at 16 weeks [ Time Frame: baseline and 16 weeks ]questionnaires: Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-Fatigue) (WEBSTER et al, 1999; WEBSTER et al, 2003)
- Change from baseline in aerobic capacity at 16 weeks [ Time Frame: baseline and 16 weeks ]
Aerobic capacity has been evaluated by spiroergometric test. A computerized metabolic system is used to analyze the data obtained breath by breath. The following outcomes of physical fitness are obtained: peak oxygen uptake (peak VO2), peak heart rate and maximum heart rate at the anaerobic threshold. Anaerobic threshold are considered the mean value of 2 blinded investigators' independent readings. Considering that patients with pSS do not achieve a maximum effort, the anaerobic threshold is the main measure of aerobic fitness (VALIM et al, 2002; VALIM et al, 2003; ASSIS et al, 2006).
All the patients have been underwent an increasing load protocol on the treadmill, with a maximum duration of 13 minutes (VALIM et al, 2002; FAIRSHTER et al, 1983). Beginning with a warm-up period of 3 minutes at 3 km/h and increasing 1 km/h each minute until 7 km/h, at this moment 2,5% inclination is added until 15% in the 13º minute.
- Change from baseline in depression at 8 weeks [ Time Frame: baseline and 8 weeks ]questionnaire: Beck Depression Inventory (BDI) (BECK et al, 1961; GORESTEIN and ANDRADE, 1996).
- Change from baseline in depression at 16 weeks [ Time Frame: baseline and 16 weeks ]questionnaire: Beck Depression Inventory (BDI) (BECK et al, 1961; GORESTEIN and ANDRADE, 1996).
- Change from baseline in disease activity at 16 weeks [ Time Frame: baseline and 16 weeks ]questionnaire: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (SEROR et al, 2010; SERRANO et al, 2013).
- Change from baseline in quality of life at 16 weeks [ Time Frame: baseline and 16 weeks ]questionnaires: Medical Outcomes Study 36 (SF-36) (CICONELLI et al, 1999) and World Health Organization Quality of Life Instrument - Abbreviated version (WHOQOL-bref) (The Whoqol Group, 1998; FLERCK et al, 2000).
- Change from baseline in symptoms at 8 weeks [ Time Frame: baseline and 8 weeks ]questionnaire: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (SEROR et al, 2011, PAGANOTTI et al, 2012; PAGANOTTI et al, 2013).
- Change from baseline in symptoms at 16 weeks [ Time Frame: baseline and 16 weeks ]questionnaire: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (SEROR et al, 2011, PAGANOTTI et al, 2012; PAGANOTTI et al, 2013).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370225
|Samira Tatiyama Miyamoto|
|Vitória, ES, Brazil, 29050780|
|Study Chair:||Jamil Natour, PhD||Universidade Federal de São Paulo|