Clinical trial NCT03130062: 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
Overall status: COMPLETED
Phase: NA
Conditions: Primary Sjögren Syndrome
Keywords: Resistance Exercise
Functional Fitness
Actigraphy
Primary Sjögren Syndrome
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in functional fitness
timeFrame: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
measure: Change in daily motor activity index
timeFrame: 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 outcomes:
measure: Quality of life estimate
timeFrame: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
measure: Estimates of disease activity
timeFrame: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: PAULO A MINALI
role: PRINCIPAL_INVESTIGATOR
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