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Resistance Exercise in Woman With Primary Sjörgen Syndrome.

Primary Purpose

Primary Sjögren Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Sjögren Syndrome focused on measuring Resistance Exercise, Functional Fitness, Actigraphy, Primary Sjögren Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of PSS - according to the criteria of the American-European Society for the classification of Primary Sjögren's Syndrome (Vitali et al., 2002);
  • Female gender
  • Aged above 18 years

Exclusion Criteria:

  • Patients who had cognitive difficulties, with diagnosis of Secondary Sjögren's Syndrome,
  • A regular physical exercise practitioner or who were practicing physical exercise regularly up to 2 months before the interview.
  • Patients in clinical conditions that prevented the practice of physical exercise according to previous medical evaluation, such as decompensated diabetes mellitus, decompensated thyroid disease, severe cardiorespiratory diseases, etc. - Use of medications that interfere with physical aspects, especially in response to the sensation of fatigue.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise

    Control

    Arm Description

    Volunteers underwent a supervised resistance exercise program for 16 weeks. The subjects performed 10 exercises with 3 sets of 10 maximum repetitions in each. The training sessions were held twice a week.

    Volunteers in this group were instructed not to perform systematic physical exercises for 16 weeks (the same period of the GEX group training program), and only the SSP medication treatment was maintained, and they were followed up during the study period.

    Outcomes

    Primary Outcome Measures

    Change in functional fitness
    The protocol consists of a sequence of 7 tests that aim to mimic the neuromotor and cardiorespiratory needs involved in the daily life activities. This battrey test was designed and validated to evaluate the elderly without a ceiling effect, ensuring that the physical aspect measured represents the maximum of the individual. The physiological components evaluated, based on the physical abilities performed in the daily activities are: upper and lower limb strength, aerobic capacity, upper and lower limb flexibility, as well as motor agility / dynamic balance. In addition, the authors added the body mass index (BMI), to estimate the body composition.
    Change in daily motor activity index
    To verify the daily movement index of the subjects we used a device called an actigraphy or actimeter.

    Secondary Outcome Measures

    Quality of life estimate
    To evaluate the quality of life, the "Medical Outcomes Study SF-36", a generic questionnaire was translated and validated for the Brazilian population (Ciconelli, 1999). To evaluate, in a generic way, the quality of life. It is a multidimensional instrument composed of 36 items evaluating in 8 dimensions thus distributed: 10 items related to functional capacity; 4 physical appearance items; 2 items on pain; 5 items related to general health status; 4 items on vitality; 2 items with respect to social aspects; 3 items on emotional aspects; 5 items related to mental health and one more question of comparative evaluation between the current health conditions and that of a year ago.
    Estimates of disease activity
    ESSDAI - Sjögren's Syndrome Disease Activity Index is a questionnaire that investigates the activity of SSP disease and has 12 domains (constitutional, lymphadenopathy, glandular, articular, cutaneous, respiratory, renal, muscular, peripheral nervous system, central nervous system, hematological, biological) (Seror et al. 2009). It was developed from a consensus study of the EULAR (European League Against Rheumatism) and the American group. His cross-cultural adaptation and validity for the Brazilian Portuguese language was performed by the Sjögren's syndrome clinic of the Rheumatology department of the Cassiano Antônio de Moraes University Hospital (HUCAM), in Vitória, Espírito Santo (Serrano et al., 2013). Disease activity is classified into 3 levels: mildly active, moderately active and highly active.

    Full Information

    First Posted
    April 16, 2017
    Last Updated
    April 25, 2017
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03130062
    Brief Title
    Resistance Exercise in Woman With Primary Sjörgen Syndrome.
    Official Title
    Effectiveness of Resistance Exercise in Daily Motor Activity Index and Functional Fitness in Women With Primary Sjögren Syndrome: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (Actual)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To analyze the effectiveness of 16-week resistance exercise in daily motor behavior and functional fitness in women with Primary Sjögren's Syndrome. The present study presents as hypothesis that a supervised resistance exercise program is effective and safe in improving the functional fitness and quality of life of patients with Primary Sjögren's Syndrome, making them more physically active, contributing positively to the capacity to perform daily life activities as household and / or professional tasks.
    Detailed Description
    Sjögren's syndrome (SS) is a systemic autoimmune inflammatory disease that affects the exocrine glands and less frequently the internal organs, presenting intense lymphoplasmacytic infiltration mainly in the epithelium of the involved tissues, leading to the destruction and loss of the secretory function. SS can manifest itself in isolation, without association with other diseases, in this situation it is called Primary Sjögren's Syndrome (PSS), being considered the second most common autoimmune rheumatic disease, prevalent in women (9: 1). The inflammatory process can affect any organ, resulting in a generally severe clinical condition, and may involve the musculoskeletal, pulmonary, gastrointestinal, hepatic, hematological, vascular, dermatological, renal and neurological systems, leading to an evident decline of the physical functions with decrease in aerobic capacity, muscular strength, joint mobility and static balance, as well as psychological and social deficit. Patients with PSS also present a marked physiological characteristic with a high level of fatigue. Thus, resistance exercise becomes a non-drug strategy, aiming to improve musculoskeletal fitness, allowing the execution of daily activities with more independence, autonomy and safety, while influencing the patient's functional fitness. The aim of the present study is to analyze the effectiveness of resistance exercise in daily motor behavior and functional fitness in women with Primary Sjögren's Syndrome. After the use of actigraphy for 15 days, equipment that measures the level of daily physical activity, and evaluation of functional fitness, volunteers underwent a supervised resistance exercise program for 16 weeks. The following muscular clusters were exerted: latissimus dorsi, deltoid, pectoralis major , triceps brachialis, biceps brachialis, quadriceps, hamstring, thigh adductor muscles, thigh abductor muscles and gastrocnemius. The subjects performed in each exercise 3 sets of 10 maximum repetitions. The training sessions were held twice a week.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Sjögren Syndrome
    Keywords
    Resistance Exercise, Functional Fitness, Actigraphy, Primary Sjögren Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The division of the groups was obtained through randomization through a computer program. An opaque envelope containing the group allocation was given to the volunteer by the blind evaluator. After randomization, the sequential numbers were kept in opaque and closed envelopes and, as patients passed the initial evaluations, were allocated to one of the groups.
    Masking
    Outcomes Assessor
    Masking Description
    The collaborators who carried out these evaluations were unaware of the allocation of volunteers.
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Description
    Volunteers underwent a supervised resistance exercise program for 16 weeks. The subjects performed 10 exercises with 3 sets of 10 maximum repetitions in each. The training sessions were held twice a week.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Volunteers in this group were instructed not to perform systematic physical exercises for 16 weeks (the same period of the GEX group training program), and only the SSP medication treatment was maintained, and they were followed up during the study period.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    The following muscular clusters were exerted: latissimus dorsi, deltoid, pectoralis major , triceps brachialis, biceps brachialis, quadriceps, hamstring, thigh adductor muscles, thigh abductor muscles and gastrocnemius.
    Primary Outcome Measure Information:
    Title
    Change in functional fitness
    Description
    The protocol consists of a sequence of 7 tests that aim to mimic the neuromotor and cardiorespiratory needs involved in the daily life activities. This battrey test was designed and validated to evaluate the elderly without a ceiling effect, ensuring that the physical aspect measured represents the maximum of the individual. The physiological components evaluated, based on the physical abilities performed in the daily activities are: upper and lower limb strength, aerobic capacity, upper and lower limb flexibility, as well as motor agility / dynamic balance. In addition, the authors added the body mass index (BMI), to estimate the body composition.
    Time Frame
    The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
    Title
    Change in daily motor activity index
    Description
    To verify the daily movement index of the subjects we used a device called an actigraphy or actimeter.
    Time Frame
    The subjects were assessed for 15 consecutive days belonging to the habitual routine of the volunteers. It was used in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
    Secondary Outcome Measure Information:
    Title
    Quality of life estimate
    Description
    To evaluate the quality of life, the "Medical Outcomes Study SF-36", a generic questionnaire was translated and validated for the Brazilian population (Ciconelli, 1999). To evaluate, in a generic way, the quality of life. It is a multidimensional instrument composed of 36 items evaluating in 8 dimensions thus distributed: 10 items related to functional capacity; 4 physical appearance items; 2 items on pain; 5 items related to general health status; 4 items on vitality; 2 items with respect to social aspects; 3 items on emotional aspects; 5 items related to mental health and one more question of comparative evaluation between the current health conditions and that of a year ago.
    Time Frame
    The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
    Title
    Estimates of disease activity
    Description
    ESSDAI - Sjögren's Syndrome Disease Activity Index is a questionnaire that investigates the activity of SSP disease and has 12 domains (constitutional, lymphadenopathy, glandular, articular, cutaneous, respiratory, renal, muscular, peripheral nervous system, central nervous system, hematological, biological) (Seror et al. 2009). It was developed from a consensus study of the EULAR (European League Against Rheumatism) and the American group. His cross-cultural adaptation and validity for the Brazilian Portuguese language was performed by the Sjögren's syndrome clinic of the Rheumatology department of the Cassiano Antônio de Moraes University Hospital (HUCAM), in Vitória, Espírito Santo (Serrano et al., 2013). Disease activity is classified into 3 levels: mildly active, moderately active and highly active.
    Time Frame
    The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a diagnosis of PSS - according to the criteria of the American-European Society for the classification of Primary Sjögren's Syndrome (Vitali et al., 2002); Female gender Aged above 18 years Exclusion Criteria: Patients who had cognitive difficulties, with diagnosis of Secondary Sjögren's Syndrome, A regular physical exercise practitioner or who were practicing physical exercise regularly up to 2 months before the interview. Patients in clinical conditions that prevented the practice of physical exercise according to previous medical evaluation, such as decompensated diabetes mellitus, decompensated thyroid disease, severe cardiorespiratory diseases, etc. - Use of medications that interfere with physical aspects, especially in response to the sensation of fatigue.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    PAULO A MINALI
    Organizational Affiliation
    Federal University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The questionaries SF-36 and ESSDAI used in the present study were shared with other researches.
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    Resistance Exercise in Woman With Primary Sjörgen Syndrome.

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