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Aerobic Exercise in Primary Sjögren's Syndrome (AEPSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 9, 2015
First Posted Date  ICMJE February 24, 2015
Last Update Posted Date August 11, 2016
Study Start Date  ICMJE March 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2015)
  • Change from baseline in fatigue at 8 weeks [ Time Frame: baseline and 8 weeks ]
    questionnaires: Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-Fatigue) (WEBSTER et al, 1999; WEBSTER et al, 2003) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (SEROR et al, 2011, PAGANOTTI et al, 2012; PAGANOTTI et al, 2013).
  • 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) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (SEROR et al, 2011, PAGANOTTI et al, 2012; PAGANOTTI et al, 2013).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2015)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2015)
  • 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 aseline 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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aerobic Exercise in Primary Sjögren's Syndrome
Official Title  ICMJE Effects of Aerobic Exercise on Fatigue in Women With Primary Sjögren's Syndrome: Randomized Controlled Trial
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.
Detailed Description

This study is a randomized controlled trial. 45 women with primary Sjögren's syndrome diagnosed according to the American European Consensus Criteria (VITALI et al, 2002) and age ≤ 65 years-old will be included. Patients, in blocks of four, will be allocated to treatment group (TG) or control group (CG) by simple randomization according to drawing lots.

Treatment group (TG): subjects will be submitted to a supervised walking, 3 times a week for 16 weeks, by one physiotherapist and one physical education student who alternated weekly. The heart rate of the patients will be registered with a pulse watch (Polar® A1, Kempele, Finland) at the beginning, in the intermediate time and at the final of effective walking time. The general exertion was rated on the Borg RPE 0-10 (ratings of perceived exertion) scale in the intermediate time and at the final of effective walking time. Each training session will be preceded by a warm-up period, where patients will be instructed to walk freely and slowly for 5 minutes, followed by 20 to 50 minutes of effective walking when they will be 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 will be based on the heart rate at the anaerobic threshold determined at the initial assessment according previous studies with patients with fibromyalgia (VALIM et al, 2002; VALIM et al, 2003; ASSIS et al, 2006) and Systemic Lupus Erythematosus (CARVALHO et al, 2005), which demonstrated that ventilatory anaerobic threshold oxygen uptake, although used less than VO2max, is also a good physical fitness indicator, and it has the advantage of not being maximum effort dependent. It seems to be more influenced by training than VO2max and represents a safer intensity for exercise, thus decreasing the risk of lesions and constituting an important measure for prescription of exercise. As there is no previous studies using spiroergometric test in pSS and fatigue is very similar to fibromyalgia and lupus patients, we believe pSS performance in treadmill test and training is probably the same. The increment of intensity exercise will be 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.

Control group (CG): subjects randomized to control group will not participate of the walking exercise initially, but after completing 16 weeks they will be invited to participate of the training group.

Clinical outcomes:

  • Fatigue: Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-Fatigue) (WEBSTER et al, 1999; WEBSTER et al, 2003)
  • Depression: Beck Depression Inventory (BDI) (BECK et al, 1961; GORESTEIN and ANDRADE, 1996).
  • Perception of pSS's symptoms: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) (SEROR et al, 2011, PAGANOTTI et al, 2012; PAGANOTTI et al, 2013).
  • Disease activity: EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) (SEROR et al, 2010; SERRANO et al, 2013).
  • Quality of life: 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).
  • All patients will be submitted to interview to evaluate fatigue, depression and perception of pSS's symptoms prior to intervention (T0), after 8 weeks (T1) and after 16 weeks (T2). Quality of life and disease activity will be evaluated prior to intervention (T0) and after 16 weeks (T2). Patient global assessment of response to therapy (PGART) on a 5-point scale (1 _ much better, 2 _ better, 3 _ slightly better, 4 _ no change, and 5 _ worse).

Physical fitness outcomes:

Aerobic capacity will be 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 will be 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.

All patients will be evaluated prior to intervention (T0) and after 16 weeks (T2).

Statistics:

An intent-to-treat analysis will be performed, using the last-observation-carried-forward method. A level of significance of P<0.05 (2-tailed tests) will be accepted for the trial. The Kolmogorov-Smirnov test will be used to determine whether data will be normally or non-normally distributed. For normally distributed data, the dependent variables will be analyzed using a 2 per 3 repeated-measures analysis of variance (ANOVA). The independent variables in all analyses is group (TG versus CG; between subjects factors) and time (baseline, 8 weeks, and 16 weeks; within subjects factors). Independent sample t-tests will be used in the between-groups comparison of the change scores at midline and treatment completion, when interaction time x group was significant. A 95% confidence interval (95% CI) will be used. Friedman's test will be used for non-normally distributed variables, as an equivalent of ANOVA. Wilcoxon's signed rank test will be used to analyze the difference between times separated by group when the change score was non-normally distributed. Fisher's exact test and chisquare test will be used to determine differences in rates of improvement between the 2 groups. Pearson's and Spearman's correlation coefficients will be used. Multiple linear regression and chi-square tests will be used to analyze the association between the amount of physical fitness improvement and outcome measures. The agreement between heart rate and ratings of perceived exertion during the training will be analyzed by Intraclass Correlation Coefficient.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sjogren's Syndrome
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: aerobic exercise
    Subjects were submitted to a supervised walking, 3 times a week for 16 weeks.
    Intervention: Other: aerobic exercise
  • 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.
Publications * Miyamoto ST, Valim V, Carletti L, Ng WF, Perez AJ, Lendrem DW, Trennel M, Giovelli RA, Dias LH, Serrano ÉV, Subtil AM, Abreu VC, Natour J. Supervised walking improves cardiorespiratory fitness, exercise tolerance, and fatigue in women with primary Sjögren's syndrome: a randomized-controlled trial. Rheumatol Int. 2019 Feb;39(2):227-238. doi: 10.1007/s00296-018-4213-z. Epub 2019 Jan 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 18, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02370225
Other Study ID Numbers  ICMJE PRPPG 3363/2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Samira Tatiyama Miyamoto, Federal University of Espirito Santo
Study Sponsor  ICMJE Samira Tatiyama Miyamoto
Collaborators  ICMJE
  • Federal University of São Paulo
  • Newcastle University
Investigators  ICMJE
Study Chair: Jamil Natour, PhD Universidade Federal de São Paulo
PRS Account Federal University of Espirito Santo
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP