Resistance Exercise in Woman With Primary Sjörgen Syndrome.

April 25, 2017 updated by: Paulo Minali, Federal University of São Paulo

Effectiveness of Resistance Exercise in Daily Motor Activity Index and Functional Fitness in Women With Primary Sjögren Syndrome: a Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
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.
Other: Exercise
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.
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in functional fitness
Time Frame: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.

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.
The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
Change in daily motor activity index
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.
To verify the daily movement index of the subjects we used a device called an actigraphy or actimeter.
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 Measures

Outcome Measure
Measure Description
Time Frame
Quality of life estimate
Time Frame: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
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.
The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
Estimates of disease activity
Time Frame: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
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.
The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: PAULO A MINALI, Federal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

April 16, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13041978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The questionaries SF-36 and ESSDAI used in the present study were shared with other researches.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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