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

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
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
NCT ID
NCT03130062
First Posted
April 16, 2017
Last Updated
April 25, 2017
Sponsor
Federal University of São Paulo
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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