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Cardiovascular evaluation Exercise in patients with Sjogren's Syndrome

Cardiovascular evaluation before and after Resisted and Aerobic Exercise program in patients with Sjogren's Syndrome: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3v3zmd
Enrollment
Unknown
Registered
2017-06-20
Start date
2014-06-01
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: 32 women with Sjogren's Syndrome will perform 28 weeks of supervised physical exercise, being 2 sessions of 1 hour per week. The first 16 weeks will be of resistance exercises, in
Weeks 3 to 5: 40-59% VO 2max for 30 min
Weeks 6 to 8: 40-59% VO 2max for 40 min
Weeks 9 to 12: 60-84% VO 2max for 50 min. Control group: 32 women with Sjogren's Syndrome will maintain traditional treatment for the disease and comorbidities, without performing physical exercises.
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 90 Years

Inclusion criteria

Inclusion criteria: Women with diagnosis of primary Sjogren's syndrome confirmed by the revised Classification Criteria of 2002; age between 18 and 90 years; understanding and signing of the free and informed consent term.

Exclusion criteria

Exclusion criteria: Diagnosis of heart, lung, endocrine, or any other disease that impedes the practice of exercise; Inflammatory joint activity that impedes the practice of exercise; Regular exercise for more than 4 weeks in the last 6 months.

Design outcomes

Primary

MeasureTime frame
15% improvement in maximum oxygen consumption (VO2max) measured by ergospirometry in relation to baseline, performed at the beginning of the study and up to 72 hours after the last training.—

Secondary

MeasureTime frame
Improvement of respiratory threshold and maximal heart rate as measured by ergospirometry; improvement of ejection fraction and left ventricular systolic and diastolic functions, measured by echocardiography; improvement of glycemic and lipemic profiles; improvement in the quality of life measured by the SF 36 questionnaire; maintenance of the disease activity index measured by the ESSDAI questionnaire. All measurements were taken up to 72 hours after the last training.—

Countries

Brazil

Contacts

Public ContactAna Beatriz Garcia

Universidade Federal de São Paulo

reumatologista@hotmail.com+55 (11) 98261 5081

Outcome results

None listed

Source: REBEC (via WHO ICTRP)