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Study on Resisted Exercise in improving Fatigue in Patients with Primary Sjogren's Syndrome: Blind Randomized Clinical Trial

Effectiveness of Resisted Exercise in improving Fatigue in Patients with Primary Sjogren's Syndrome: Blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8j2r7d
Enrollment
Unknown
Registered
2020-08-05
Start date
2014-05-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's syndrome

Interventions

Experimental group: 29 women with primary sjogren's syndrome and fatigue performed 16 weeks of resistance exercise (twice a week, for one hour). Control Group: 30 women with primary sjogren's syndrome
Other
G11.427.410.698.277

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Be diagnosed with Sjogren's syndrome according the American-European Consensus criteria, having fatigue complaint, age above 18 years, woman.

Exclusion criteria

Exclusion criteria: Patients with cognitive difficulties, secondary Sjogren's Syndrome; regular physical activity practitioner or who had been practicing physical activity regularly for up to 8 weeks prior to initiation of the protocol; patients who did not accept the study norms; those with clinical conditions that precluded the practice of exercise program according to previous medical evaluation( such as decompensated diabetes mellitus, decompensated thyroid diseases, cardiorespiratory diseases); systemic diseases such as renal failure, liver failure, anemia and muscle inflammation; use of hypnotic or immunotherapeutic medications such as rituximab; age below 18 years or above 100 years; men

Design outcomes

Primary

MeasureTime frame
Evaluate improvements of at least 30% of fatigue, measured using a scale and 3 questions listed below. Data will be collected pre and post 16 weeks of resistance training - visual analog fatigue scale (ranges from 0 to 100, being 0 without fatigue); - Profile of Fatigue questionnaire (total score from 0 to 112 - being 0 without fatigue, and each domain variable from 0 to 7 - being 0 without fatigue; - ESSPRI ranges from 0 to 10 for each of its 11 domains, with 0 being no fatigue - FACIT-f ranges from 0 to 52, with 0 without fatigue

Secondary

MeasureTime frame
quality of life through the SF-36 questionnaire, with at least 30% improvement expected, performed before and at the end of the training protocol;pain: through the visual analog scale (VAS-pain, varies from 0 to 100 with 0 being no pain), with at least 30% of improvement expected before and at the end of the training protocol;disease activity: through ESSDAI, which is a questionnaire completed by the doctor and which investigates the activity of the primary Sjogren's syndrome disease and has 12 domains ranging from 0 to 18 (0 being no activity). It is expected that there will be no variation in the value, that is, that there will be no variation in disease activity between the periods before and after the training protocol.

Countries

Brazil

Contacts

Public Contactluciana dardin

Universidade Federal de São Paulo

lucianadardin@gmail.com+55-011-984487888

Outcome results

None listed

Source: REBEC (via WHO ICTRP)