Systemic Lupus ErythematosusPhase 1LESPANCT00985803
Physical Activity in Patients With Systemic Lupus Erythematosus
A Phase 1 study testing Physical Activity: Cardio training (CT) and Physical Activity: Endurance exercise training (ET) in people with Systemic Lupus Erythematosus, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to check the improvement in quality of life in patients with systemic lupus incorporated into a routine of physical activity. Randomized controlled blinded trial, 63 patients aged 42.9 ± 14.4 and diagnosis of systemic lupus erythematosus (SLE) according to the criteria of the College… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Physical Activity: Cardio training (CT) and Physical Activity: Endurance exercise training (ET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2009to Mar 2010
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- (American College of Rheumatology). It is necessary to have the presence of room between the elevens criteria for diagnosis:
- malar erythema
- discoid lesions
- photosensitivity
- oral or nasal ulcers
- arthritis
Show all 12Show fewer
- serositis
- renal
- neurological
- hematological
- immunological changes
- antinuclear antibodies.
Who cannot join
- Patients with hemoglobin level 10gm/dL, sequelae of cardiovascular events, - Respiratory diseases (pulmonary hypertension, pulmonary fibrosis
- Bronchitis, asthma, emphysema)
- Heart failure (NYHA> II)
- History of myocardial ischemia or heart
- Blood pressure> 100 mm Hg.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
AmbulatoAmbulatory Specialty Interlagos - General Hospital Grajaú - Association Congregation Santa Catarina
São Paulo, São Paulo, 04671300
About this study
Official title: Comparison of Cardiovascular Training Versus Resistance Training In Patients With Systemic Lupus Erythematosus: Controlled Randomized Clinical Trial
The purpose of this study is to check the improvement in quality of life in patients with systemic lupus incorporated into a routine of physical activity.
Randomized controlled blinded trial, 63 patients aged 42.9 ± 14.4 and diagnosis of systemic lupus erythematosus (SLE) according to the criteria of the College American Rheumatology, 1997. After randomization patients were allocated into 3 groups, control group (CG) (n = 21), training cardiovascular (CT) (n = 20), resistance training (RT) (n = 22), performing 12 weeks of intervention with a frequency of three times weeks and were evaluated at two different times (T0 and T12). As primary outcome quality of life was assessed by the inventory Generic Assessment of quality of life by the Medical Outcomes Study 36 -- Healthy ItemShort Form Survey (SF36) and as secondary outcomes functional capacity evaluation of pain symptoms (visual scale analogue pain [VAS]), intensity of symptoms of depression (Beck Depression Inventory [BDI]), index of disease activity (Systemic Lupus Disease Activity Inventory Erythmatodud [SLEDAI]), capacity aerobic (walking test of 12 minutes [T12]), subjective perception effort (subjective scale of Borg [Borg]), limb muscle strength lower (analog dynamometer [strength]), electrical activity member lower (surface electromyography [EMG]), amount of products (inventory amount of Medicines).
Read the detailed description
Will be selected 60 patients of both genders aged between 18 -55 years, with make the diagnosis of SLE by the criteria of the Americam College of Rheumatology revised in 1997 and that are not physically active.
After screening, patients will read and sign the informed consent form. The study will be submitted to the ethics committee of the Federal University of São Paulo / Escola Paulista de Medicina.
Randomization will be done by a secretary using a computer program specifically for this purpose, where the groups will be divided into intervention and control. The random allocation will be maintained using opaque sealed envelopes, which will open at the time of intervention.
Control group will not perform any type of training. Since the experimental group will be divided into two groups, cardio training (CT) and endurance exercise training (ET).
Evaluation will be conducted at the beginning and end of 12 weeks by two raters blind (who will not know to which groups, individuals were allocated) that will use the following tools:
- Outcomes
- Assessment of pain
- Assessment of pain before and after training, the visual analog scale of pain, ranging from 0 (zero) no pain and 10 cm (ten) 14 unbearable pain
Evaluation of the depression:
Evaluation of the depression at the beginning and end of the proposed training, inventory Beck Depression Inventory. (BDI). This inventory of multiple choice will be used to measure the severity of depression. These include symptoms of depression, irritability, cognitive impairment, guilt, feelings of being punished, physical symptoms such as fatigue, weight loss, lack of interest in sex.
Assessment of quality of life:
Generic Assessment of quality of life by the SF 36 (Short From 36), beginning and end of the proposed treatment. Validated in Portuguese in 1999 (Ciconelli et al, 1999). It consists of eight domains (physical functioning, limitation in physical appearance, bodily pain, general health, vitality, social, emotional, and mental health ranging from 0 (zero) to 100 (one hundred), and the higher the note is better quality of life.
Activity disease:
Activity Level by Systemic Lupus Erythematosus Disease Activity Inventory (SLEDAI) at the beginning and end of the proposed treatment.
Aerobic Capacity:
Cooper test of walking and / or running in 12 minutes. Only for the experimental group of aerobic training, aiming to prescribe the training range cardiovascular.O test aims to measure the aerobic capacity of subjects. The test results will be classified as "VERY GOOD", "GOOD", "MIDDLE", "BAD", "very poor", which will be based on distance traveled, age and sex of the individual being evaluated.
Muscle strength:
Evaluation of muscle strength through a load cell placed in a leg extension to 60 degrees of extension.
Activity Muscle:
Assessment of quadriceps muscle activation using electromyography
The experimental group of cardiovascular training will hold a training still between 55% to 65% of maximum heart rate ..
The experimental group of resistance training will carry out the training with 8 years of training session with 12 reps with that load will vary according to the 1 RM test.
The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Physical Activity: Cardio training (CT), Physical Activity: Endurance exercise training (ET)
- Keywords
- Systemic Lupus Erythematosus, Activity Physical, Activity Disease,trials randomized
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity: Cardio training (CT)Other
The experimental group of resistance training will carry out the training with 8 kinds of training session with 12 reps with that load will vary according to the 1 RM test.
The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling.
Physical Activity: Endurance exercise training (ET)Other
The experimental group of resistance training will carry out the training with 8 kinds of training session with 12 reps with that load will vary according to the 1 RM test.
The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling.
| Study group | Role | What they receive |
|---|---|---|
| Group Control | No intervention | Not described |
| Endurance | Experimental | Not described Receives: Other: Physical Activity: Endurance exercise training (ET) |
| Cardiovascular | Experimental | Not described Receives: Other: Physical Activity: Cardio training (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life quality
Measured: 12 weeks
Secondary outcomes (4)
Pain
Measured: 12 weeks
Strength
Measured: 12 weeks
Electromyography
Measured: 12 weeks
Aerobic capacity
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Marcelo I Abrahão, Principal investigator, University Federal of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985803
- Sponsor's protocol ID
- MAbrahao
- Acronym
- LESPA
- Status last verified
- Oct 2009
- First submitted
- 26 Sep 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiovascular Training Versus Resistance Training In Patients With Systemic Lupus Erythematosus: Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00985803
- Acronym / sponsor ID
- LESPA / MAbrahao
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Activity Physical, Activity Disease,trials randomized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2009
- Study completion
- Mar 2010
- First posted
- 28 Sep 2009 (estimated)
- 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.
The purpose of this study is to check the improvement in quality of life in patients with systemic lupus incorporated into a routine of physical activity.
Randomized controlled blinded trial, 63 patients aged 42.9 ± 14.4 and diagnosis of systemic lupus erythematosus (SLE) according to the criteria of the College American Rheumatology, 1997. After randomization patients were allocated into 3 groups, control group (CG) (n = 21), training cardiovascular (CT) (n = 20), resistance training (RT) (n = 22), performing 12 weeks of intervention with a frequency of three times weeks and were evaluated at two different times (T0 and T12). As primary outcome quality of life was assessed by the inventory Generic Assessment of quality of life by the Medical Outcomes Study 36 -- Healthy ItemShort Form Survey (SF36) and as secondary outcomes functional capacity evaluation of pain symptoms (visual scale analogue pain [VAS]), intensity of symptoms of depression (Beck Depression Inventory [BDI]), index of disease activity (Systemic Lupus Disease Activity Inventory Erythmatodud [SLEDAI]), capacity aerobic (walking test of 12 minutes [T12]), subjective perception effort (subjective scale of Borg [Borg]), limb muscle strength lower (analog dynamometer [strength]), electrical activity member lower (surface electromyography [EMG]), amount of products (inventory amount of Medicines).
Detailed description
Will be selected 60 patients of both genders aged between 18 -55 years, with make the diagnosis of SLE by the criteria of the Americam College of Rheumatology revised in 1997 and that are not physically active.
After screening, patients will read and sign the informed consent form. The study will be submitted to the ethics committee of the Federal University of São Paulo / Escola Paulista de Medicina.
Randomization will be done by a secretary using a computer program specifically for this purpose, where the groups will be divided into intervention and control. The random allocation will be maintained using opaque sealed envelopes, which will open at the time of intervention.
Control group will not perform any type of training. Since the experimental group will be divided into two groups, cardio training (CT) and endurance exercise training (ET).
Evaluation will be conducted at the beginning and end of 12 weeks by two raters blind (who will not know to which groups, individuals were allocated) that will use the following tools:
- Outcomes
- Assessment of pain
- Assessment of pain before and after training, the visual analog scale of pain, ranging from 0 (zero) no pain and 10 cm (ten) 14 unbearable pain
Evaluation of the depression:
Evaluation of the depression at the beginning and end of the proposed training, inventory Beck Depression Inventory. (BDI). This inventory of multiple choice will be used to measure the severity of depression. These include symptoms of depression, irritability, cognitive impairment, guilt, feelings of being punished, physical symptoms such as fatigue, weight loss, lack of interest in sex.
Assessment of quality of life:
Generic Assessment of quality of life by the SF 36 (Short From 36), beginning and end of the proposed treatment. Validated in Portuguese in 1999 (Ciconelli et al, 1999). It consists of eight domains (physical functioning, limitation in physical appearance, bodily pain, general health, vitality, social, emotional, and mental health ranging from 0 (zero) to 100 (one hundred), and the higher the note is better quality of life.
Activity disease:
Activity Level by Systemic Lupus Erythematosus Disease Activity Inventory (SLEDAI) at the beginning and end of the proposed treatment.
Aerobic Capacity:
Cooper test of walking and / or running in 12 minutes. Only for the experimental group of aerobic training, aiming to prescribe the training range cardiovascular.O test aims to measure the aerobic capacity of subjects. The test results will be classified as "VERY GOOD", "GOOD", "MIDDLE", "BAD", "very poor", which will be based on distance traveled, age and sex of the individual being evaluated.
Muscle strength:
Evaluation of muscle strength through a load cell placed in a leg extension to 60 degrees of extension.
Activity Muscle:
Assessment of quadriceps muscle activation using electromyography
The experimental group of cardiovascular training will hold a training still between 55% to 65% of maximum heart rate ..
The experimental group of resistance training will carry out the training with 8 years of training session with 12 reps with that load will vary according to the 1 RM test.
The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Control | No intervention | – |
| Endurance | Experimental | Other: Physical Activity: Endurance exercise training (ET) |
| Cardiovascular | Experimental | Other: Physical Activity: Cardio training (CT) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- (American College of Rheumatology). It is necessary to have the presence of room between the elevens criteria for diagnosis:
Key exclusion criteria (5 listed)
- Patients with hemoglobin level 10gm/dL, sequelae of cardiovascular events, - Respiratory diseases (pulmonary hypertension, pulmonary fibrosis
- Bronchitis, asthma, emphysema)
- Heart failure (NYHA> II)
- History of myocardial ischemia or heart
- Blood pressure> 100 mm Hg.
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 |
|---|---|---|
| Physical Activity: Cardio training (CT)The experimental group of resistance training will carry out the training with 8 kinds of training session with 12 reps with that load will vary according to the 1 RM test. The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling. | Other | Cardiovascular |
| Physical Activity: Endurance exercise training (ET)The experimental group of resistance training will carry out the training with 8 kinds of training session with 12 reps with that load will vary according to the 1 RM test. The composition of the training session is 10 minutes of heating and stretching, 40 minutes of cardiovascular training and 10 minutes of cooling. | Other | Endurance |
Primary outcome
Life quality
Time frame: 12 weeks
4 secondary outcomes
Pain
Time frame: 12 weeks
Strength
Time frame: 12 weeks
Electromyography
Time frame: 12 weeks
Aerobic capacity
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2009.
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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.
Marcelo I Abrahão principal investigator
University Federal of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical Activity: Cardio training (CT) and Physical Activity: Endurance exercise training (ET) in people with Systemic Lupus Erythematosus, run by Federal University of São Paulo at 1 site in Brazil.
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 12 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Life quality (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2009.