Primary Sjögren SyndromeNCT03130062
Resistance Exercise in Woman With Primary Sjörgen Syndrome.
A study testing Exercise in people with Primary Sjögren Syndrome, run by Federal University of São Paulo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Sjögren Syndrome
- Being tested
- Exercise
- Keywords
- Resistance Exercise, Functional Fitness, Actigraphy, Primary Sjögren Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 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. Receives: Other: Exercise |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in functional fitness
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.
Measured: 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
To verify the daily movement index of the subjects we used a device called an actigraphy or actimeter.
Measured: 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 (2)
Quality of life estimate
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.
Measured: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
Estimates of disease activity
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.
Measured: The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study startJan 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Minali, Federal University of São Paulo
- Investigators
- PAULO A MINALI, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130062
- Sponsor's protocol ID
- 13041978
- Status last verified
- Apr 2017
- First submitted
- 16 Apr 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The questionaries SF-36 and ESSDAI used in the present study were shared with other researches.
Publications
Baillet A, Vaillant M, Guinot M, Juvin R, Gaudin P. Efficacy of resistance exercises in rheumatoid arthritis: meta-analysis of randomized controlled trials. Rheumatology (Oxford). 2012 Mar;51(3):519-27. doi: 10.1093/rheumatology/ker330. Epub 2011 Nov 24.
PubMed 22120463Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.
PubMed 23798298Cook DB, Nagelkirk PR, Poluri A, Mores J, Natelson BH. The influence of aerobic fitness and fibromyalgia on cardiorespiratory and perceptual responses to exercise in patients with chronic fatigue syndrome. Arthritis Rheum. 2006 Oct;54(10):3351-62. doi: 10.1002/art.22124.
PubMed 17009309O'Grady M, Fletcher J, Ortiz S. Therapeutic and physical fitness exercise prescription for older adults with joint disease: an evidence-based approach. Rheum Dis Clin North Am. 2000 Aug;26(3):617-46. doi: 10.1016/s0889-857x(05)70159-9.
PubMed 10989515Hakkinen A, Sokka T, Kautiainen H, Kotaniemi A, Hannonen P. Sustained maintenance of exercise induced muscle strength gains and normal bone mineral density in patients with early rheumatoid arthritis: a 5 year follow up. Ann Rheum Dis. 2004 Aug;63(8):910-6. doi: 10.1136/ard.2003.013003.
PubMed 15249317Peterson MD, Rhea MR, Sen A, Gordon PM. Resistance exercise for muscular strength in older adults: a meta-analysis. Ageing Res Rev. 2010 Jul;9(3):226-37. doi: 10.1016/j.arr.2010.03.004. Epub 2010 Apr 10.
PubMed 20385254Rooks DS, Silverman CB, Kantrowitz FG. The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Arthritis Rheum. 2002 Feb;47(1):22-8. doi: 10.1002/art1.10180.
PubMed 11932874Stenstrom CH, Minor MA. Evidence for the benefit of aerobic and strengthening exercise in rheumatoid arthritis. Arthritis Rheum. 2003 Jun 15;49(3):428-34. doi: 10.1002/art.11051. No abstract available.
PubMed 12794800Champey J, Corruble E, Gottenberg JE, Buhl C, Meyer T, Caudmont C, Berge E, Pellet J, Hardy P, Mariette X. Quality of life and psychological status in patients with primary Sjogren's syndrome and sicca symptoms without autoimmune features. Arthritis Rheum. 2006 Jun 15;55(3):451-7. doi: 10.1002/art.21990.
PubMed 16739213Barendregt PJ, Visser MR, Smets EM, Tulen JH, van den Meiracker AH, Boomsma F, Markusse HM. Fatigue in primary Sjogren's syndrome. Ann Rheum Dis. 1998 May;57(5):291-5. doi: 10.1136/ard.57.5.291.
PubMed 9741313Belenguer R, Ramos-Casals M, Brito-Zeron P, del Pino J, Sentis J, Aguilo S, Font J. Influence of clinical and immunological parameters on the health-related quality of life of patients with primary Sjogren's syndrome. Clin Exp Rheumatol. 2005 May-Jun;23(3):351-6.
PubMed 15971423Dassouki T, Benatti FB, Pinto AJ, Roschel H, Lima FR, Augusto K, Pasoto S, Pereira RMR, Gualano B, de Sa Pinto AL. Objectively measured physical activity and its influence on physical capacity and clinical parameters in patients with primary Sjogren's syndrome. Lupus. 2017 Jun;26(7):690-697. doi: 10.1177/0961203316674819. Epub 2016 Oct 26.
PubMed 27798360d'Elia HF, Rehnberg E, Kvist G, Ericsson A, Konttinen Y, Mannerkorpi K. Fatigue and blood pressure in primary Sjogren's syndrome. Scand J Rheumatol. 2008 Jul-Aug;37(4):284-92. doi: 10.1080/03009740801907995.
PubMed 18612929Hackett KL, Newton JL, Frith J, Elliott C, Lendrem D, Foggo H, Edgar S, Mitchell S, Ng WF. Impaired functional status in primary Sjogren's syndrome. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1760-4. doi: 10.1002/acr.21738.
PubMed 23111856Lendrem D, Mitchell S, McMeekin P, Bowman S, Price E, Pease CT, Emery P, Andrews J, Lanyon P, Hunter J, Gupta M, Bombardieri M, Sutcliffe N, Pitzalis C, McLaren J, Cooper A, Regan M, Giles I, Isenberg D, Vadivelu S, Coady D, Dasgupta B, McHugh N, Young-Min S, Moots R, Gendi N, Akil M, Griffiths B, Ng WF; UK primary Sjogren's Syndrome Registry. Health-related utility values of patients with primary Sjogren's syndrome and its predictors. Ann Rheum Dis. 2014 Jul;73(7):1362-8. doi: 10.1136/annrheumdis-2012-202863. Epub 2013 Jun 12.
PubMed 23761688
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Resistance Exercise in Daily Motor Activity Index and Functional Fitness in Women With Primary Sjögren Syndrome: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03130062
- Acronym / sponsor ID
- 13041978
- Conditions
- Primary Sjögren Syndrome
- Keywords
- Resistance Exercise, Functional Fitness, Actigraphy, Primary Sjögren Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseVolunteers 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe following muscular clusters were exerted: latissimus dorsi, deltoid, pectoralis major , triceps brachialis, biceps brachialis, quadriceps, hamstring, thigh adductor muscles, thigh abductor muscles and gastrocnemius. | Other | Exercise |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Results publication: PubMed 22120463Baillet A, Vaillant M, Guinot M, Juvin R, Gaudin P. Efficacy of resistance exercises in rheumatoid arthritis: meta-analysis of randomized controlled trials. Rheumatology (Oxford). 2012 Mar;51(3):519-27. doi: 10.1093/rheumatology/ker330. Epub 2011 Nov 24.
- Results publication: PubMed 23798298Booth FW, Roberts CK, Laye MJ. Lack of exercise is a major cause of chronic diseases. Compr Physiol. 2012 Apr;2(2):1143-211. doi: 10.1002/cphy.c110025.
- Results publication: PubMed 17009309Cook DB, Nagelkirk PR, Poluri A, Mores J, Natelson BH. The influence of aerobic fitness and fibromyalgia on cardiorespiratory and perceptual responses to exercise in patients with chronic fatigue syndrome. Arthritis Rheum. 2006 Oct;54(10):3351-62. doi: 10.1002/art.22124.
- Results publication: PubMed 10989515O'Grady M, Fletcher J, Ortiz S. Therapeutic and physical fitness exercise prescription for older adults with joint disease: an evidence-based approach. Rheum Dis Clin North Am. 2000 Aug;26(3):617-46. doi: 10.1016/s0889-857x(05)70159-9.
- Results publication: PubMed 15249317Hakkinen A, Sokka T, Kautiainen H, Kotaniemi A, Hannonen P. Sustained maintenance of exercise induced muscle strength gains and normal bone mineral density in patients with early rheumatoid arthritis: a 5 year follow up. Ann Rheum Dis. 2004 Aug;63(8):910-6. doi: 10.1136/ard.2003.013003.
- Results publication: PubMed 20385254Peterson MD, Rhea MR, Sen A, Gordon PM. Resistance exercise for muscular strength in older adults: a meta-analysis. Ageing Res Rev. 2010 Jul;9(3):226-37. doi: 10.1016/j.arr.2010.03.004. Epub 2010 Apr 10.
- Results publication: PubMed 11932874Rooks DS, Silverman CB, Kantrowitz FG. The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Arthritis Rheum. 2002 Feb;47(1):22-8. doi: 10.1002/art1.10180.
- Results publication: PubMed 12794800Stenstrom CH, Minor MA. Evidence for the benefit of aerobic and strengthening exercise in rheumatoid arthritis. Arthritis Rheum. 2003 Jun 15;49(3):428-34. doi: 10.1002/art.11051. No abstract available.
- Results publication: PubMed 16739213Champey J, Corruble E, Gottenberg JE, Buhl C, Meyer T, Caudmont C, Berge E, Pellet J, Hardy P, Mariette X. Quality of life and psychological status in patients with primary Sjogren's syndrome and sicca symptoms without autoimmune features. Arthritis Rheum. 2006 Jun 15;55(3):451-7. doi: 10.1002/art.21990.
- Results publication: PubMed 9741313Barendregt PJ, Visser MR, Smets EM, Tulen JH, van den Meiracker AH, Boomsma F, Markusse HM. Fatigue in primary Sjogren's syndrome. Ann Rheum Dis. 1998 May;57(5):291-5. doi: 10.1136/ard.57.5.291.
- Results publication: PubMed 15971423Belenguer R, Ramos-Casals M, Brito-Zeron P, del Pino J, Sentis J, Aguilo S, Font J. Influence of clinical and immunological parameters on the health-related quality of life of patients with primary Sjogren's syndrome. Clin Exp Rheumatol. 2005 May-Jun;23(3):351-6.
- Results publication: PubMed 27798360Dassouki T, Benatti FB, Pinto AJ, Roschel H, Lima FR, Augusto K, Pasoto S, Pereira RMR, Gualano B, de Sa Pinto AL. Objectively measured physical activity and its influence on physical capacity and clinical parameters in patients with primary Sjogren's syndrome. Lupus. 2017 Jun;26(7):690-697. doi: 10.1177/0961203316674819. Epub 2016 Oct 26.
- Individual participant dataSharing planned: Yes. The questionaries SF-36 and ESSDAI used in the present study were shared with other researches.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PAULO A MINALI principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Primary Sjögren Syndrome, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130062, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.