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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
Sponsor:
Collaborators:
Federal University of São Paulo
Newcastle University
Information provided by (Responsible Party):
Samira Tatiyama Miyamoto, Federal University of Espirito Santo

Brief Summary:
The purpose of this sudy is to investigate the effects of a regular aerobic exercise on aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease activity in women with pSS.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Other: aerobic exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female gender and age ≤ 65 years-old
  • pSS diagnosed according to the American European Consensus Criteria (VITALI et al, 2002)
  • corporal mass index < 40.

Exclusion Criteria:

  • use of beta-blocker therapy;
  • severe manifestations on pulmonary, renal, neurologic or musculoskeletal system (from the disease or not);
  • limiting or hindering their ability to walking performance
  • those who had performed regular physical activity in the 6 weeks before trial.

Information from the National Library of Medicine

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


Locations
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Brazil
Samira Tatiyama Miyamoto
Vitória, ES, Brazil, 29050780
Sponsors and Collaborators
Samira Tatiyama Miyamoto
Federal University of São Paulo
Newcastle University
Investigators
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Study Chair: Jamil Natour, PhD Universidade Federal de São Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samira Tatiyama Miyamoto, Prof MSc, Federal University of Espirito Santo
ClinicalTrials.gov Identifier: NCT02370225    
Other Study ID Numbers: PRPPG 3363/2012
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Samira Tatiyama Miyamoto, Federal University of Espirito Santo:
sjogren's syndrome
aerobic exercise
fatigue
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases