NCT02370225

Brief Summary

The purpose of this sudy is to investigate the effects of a regular aerobic exercise on aerobic capacity, fatigue, depression, quality of life, perception of symptoms and disease activity in women with pSS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

February 9, 2015

Last Update Submit

March 19, 2026

Conditions

Sjogren's Syndrome

Keywords

sjogren's syndromeaerobic exercisefatigue

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in fatigue at 16 weeks

    questionnaires: Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-Fatigue) (WEBSTER et al, 1999; WEBSTER et al, 2003)

    baseline and 16 weeks

Secondary Outcomes (7)

  • Change from baseline in aerobic capacity at 16 weeks

    baseline and 16 weeks

  • Change from baseline in depression at 8 weeks

    baseline and 8 weeks

  • Change from baseline in depression at 16 weeks

    baseline and 16 weeks

  • Change from baseline in disease activity at 16 weeks

    baseline and 16 weeks

  • Change from baseline in quality of life at 16 weeks

    baseline and 16 weeks

  • +2 more secondary outcomes

Study Arms (2)

aerobic exercise

EXPERIMENTAL

Subjects were submitted to a supervised walking, 3 times a week for 16 weeks.

Other: aerobic exercise

no exercise

NO INTERVENTION

Subjects randomized to control group did not participate of the walking exercise initially, but after completing 16 weeks they were invited to participate of the training group.

Interventions

aerobic exerciseOTHER

Each training session was preceded by a warm-up period, where patients were instructed to walk freely and slowly for 5 minutes, followed by 20 to 50 minutes of effective walking when they were instructed to maintain their paces to achieve the target heart rate and ending by a cold-up period for 5 minutes (similar to warm-up period). The exercise prescription was based on the heart rate at the anaerobic threshold determined at the initial assessment. The increment of intensity exercise was based on time: 30 in the first 2 weeks, adding 5 minutes per week until eighth week, completing 60 minutes, which remains until the end.

aerobic exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female gender and age ≤ 65 years-old
  • pSS diagnosed according to the American European Consensus Criteria (VITALI et al, 2002)
  • corporal mass index \< 40.

You may not qualify if:

  • use of beta-blocker therapy;
  • severe manifestations on pulmonary, renal, neurologic or musculoskeletal system (from the disease or not);
  • limiting or hindering their ability to walking performance
  • those who had performed regular physical activity in the 6 weeks before trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samira Tatiyama Miyamoto

Vitória, Espírito Santo, 29050780, Brazil

Location

Related Publications (1)

  • Miyamoto ST, Valim V, Carletti L, Ng WF, Perez AJ, Lendrem DW, Trennel M, Giovelli RA, Dias LH, Serrano EV, Subtil AM, Abreu VC, Natour J. Supervised walking improves cardiorespiratory fitness, exercise tolerance, and fatigue in women with primary Sjogren's syndrome: a randomized-controlled trial. Rheumatol Int. 2019 Feb;39(2):227-238. doi: 10.1007/s00296-018-4213-z. Epub 2019 Jan 2.

    PMID: 30604204DERIVED

MeSH Terms

Conditions

Sjogren's SyndromeFatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jamil Natour, PhD

    Universidade Federal de São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof MSc

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 24, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

BR(1)