Physical ActivityNCT03750929
Aerobic Capacity and Strength Exercise in Takayasu's Arteritis
A study testing Combined acute physical exercises (strength and aerobic) in people with Physical Activity and Takayasu Arteritis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their main branches. The objectives of the present study were to assess: a) the aerobic capacity (CA); b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Takayasu Arteritis
- What is being tested?
- Combined acute physical exercises (strength and aerobic)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 29 Apr 2021
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Classification criteria of Takayasu's arteritis
- Sedentarism
Who cannot join
- Peripherical arterial diseases
- Non-controlled cardiovascular diseases
- Neurological diseases
- Patients with walking problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters
Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their main branches. The objectives of the present study were to assess: a) the aerobic capacity (CA); b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokines
Read the detailed description
Takayasu's arteritis (TA) is a primary systemic vasculitis that affects large vessels and their main branches. It mainly affects young women. Blood vessel inflammation may result in stenosis, occlusions, ectasias and/or aneurysms and, consequently, difference of blood pressure between limbs and vascular claudication. Aerobic capacity (CA) is the measure of oxygen uptake, transport and use by the body, characterizing the individual's ability to perform activity. It is also a tool that can predict cardiovascular diseases. Our group has been a pioneer in demonstrating that CA is decreased in the small sample of the young women with TA. In addition, the safety and efficacy of aerobic exercises in this sample of patients were shown, as well as the influence of these sessions on the pro-inflammatory and angiogenic serum levels of the cytokines. However, due to the small samples, it was not possible to correlate CA with clinical and laboratory parameters and also with the presence of vascular damage. Moreover, to date, no studies have evaluated securityof an acute strength exercise session in TA.Therefore, thes objectives of the present study were to evaluate: a) the CA; b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokine.
- Conditions
- Physical Activity, Takayasu Arteritis
- Being tested
- Combined acute physical exercises (strength and aerobic)
- Keywords
- Takayasus's arteritis, Physical exercises, Rheumatic diseases, Systemic vasculitis
- Medical subject headings
- Motor Activity, Takayasu Arteritis, Rheumatic Diseases, Systemic Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined acute physical exercises (strength and aerobic)Other
Patients will be submmitted to combined acute physical exercises (strength and aerobic)
| Study group | Role | What they receive |
|---|---|---|
| Non physical exercises | No intervention | Patients will not be submmitted to combined acute physical exercises (strength and aerobic) |
| Physical exercises | Experimental | Patients will be submmitted to combined acute physical exercises (strength and aerobic) that consist on: supine, paddling, leg press 45º, knee extensor, flexor knee (two sets of 15 to 20 repetitions, with loads between 30% and 40% of a maximum repetition, with 30 seconds of interval). We will perform in the first exercise for upper and lower limbs, for heating, after starting the training where 4 series of 8 to 12 maximum repetitions will be performed, using the load between 70% and 80% of 1 maximum repetitions, already evaluated. The recovery between sets will be 90 seconds and between exercises will be 120 seconds. Receives: Other: Combined acute physical exercises (strength and aerobic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Security of acute session of combined physical exercises
Acute aerobic with strength muscle test exercise
Measured: One week before the exercises
Secondary outcomes (9)
Healthy Assessment Questionnaire (HAQ)
Especific questionnaire to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst).
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Laboratory analysis (Serum levels of the protein C-reactive)
Protein C-reactive (< 5 mg/dL or not) will be analyzed to evaluate degree of disease activity
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Indian Takayasu's Arteritis Activity Score (ITAS 2010)
Analyzing TA disease activity. Questionnaire with 44 items with 33 features arising from the cardiovascular system. Seven key items are weighted to score 2 and all others score 1 only. Activity was defined as ITAS 2010 score of ≥ 2 YES items
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Cardiopulmonary test
Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion (VO2) (mL/kg/minutes). VO2peak will be considered as the average of the final 30 seconds of the test.
Measured: Once (within 1 week before acute combined physical exercises)
Laboratory analysis (Erythrocyte rate sedimentation)
Erythrocyte rate sedimentation (reference: < 20 mm/ first hour) will be analyzed to evaluate degree of disease activity
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 1
The dynamic 1 maximum repetition for the bench-press exercises. The value of maximum repetition depending on each patient (unit: Newton).
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 2
The dynamic 1 maximum repetition for the leg-press press exercises. The value of maximum repetition depending on each patient (unit: Newton).
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 3
The dynamic 1 maximum repetition for the arm curl (with the dominant arm). The value of maximum repetition depending on each patient (unit: Newton).
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 4
Isometric strength (assessed by handgrip, with the dominant arm) will be assessed. The value of maximum strenght will depend on each patient (unit: Newton).
Measured: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Oct 2018
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
- Investigators
- Samuel K Shinjo, Principal investigator, Universidade de Sao Paulo - Rheumatology Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750929
- Sponsor's protocol ID
- MYO-HCFMUSP-05
- Status last verified
- Apr 2021
- First submitted
- 16 Nov 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters
- ClinicalTrials.gov ID
- NCT03750929
- Acronym / sponsor ID
- MYO-HCFMUSP-05
- Conditions
- Physical Activity, Takayasu Arteritis
- Keywords
- Takayasus's arteritis, Physical exercises, Rheumatic diseases, Systemic vasculitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 23 Nov 2018 (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.
Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their main branches. The objectives of the present study were to assess: a) the aerobic capacity (CA); b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokines
Detailed description
Takayasu's arteritis (TA) is a primary systemic vasculitis that affects large vessels and their main branches. It mainly affects young women. Blood vessel inflammation may result in stenosis, occlusions, ectasias and/or aneurysms and, consequently, difference of blood pressure between limbs and vascular claudication. Aerobic capacity (CA) is the measure of oxygen uptake, transport and use by the body, characterizing the individual's ability to perform activity. It is also a tool that can predict cardiovascular diseases. Our group has been a pioneer in demonstrating that CA is decreased in the small sample of the young women with TA. In addition, the safety and efficacy of aerobic exercises in this sample of patients were shown, as well as the influence of these sessions on the pro-inflammatory and angiogenic serum levels of the cytokines. However, due to the small samples, it was not possible to correlate CA with clinical and laboratory parameters and also with the presence of vascular damage. Moreover, to date, no studies have evaluated securityof an acute strength exercise session in TA.Therefore, thes objectives of the present study were to evaluate: a) the CA; b) security of the acute strength exercise session; c) correlation between CA, as well as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and presence and degree of vascular damage; d) serum levels of the cytokine.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non physical exercises | No intervention | –Patients will not be submmitted to combined acute physical exercises (strength and aerobic) |
| Physical exercises | Experimental | Other: Combined acute physical exercises (strength and aerobic)Patients will be submmitted to combined acute physical exercises (strength and aerobic) that consist on: supine, paddling, leg press 45º, knee extensor, flexor knee (two sets of 15 to 20 repetitions, with loads between 30% and 40% of a maximum repetition, with 30 seconds of interval). We will perform in the first exercise for upper and lower limbs, for heating, after starting the training where 4 series of 8 to 12 maximum repetitions will be performed, using the load between 70% and 80% of 1 maximum repetitions, already evaluated. The recovery between sets will be 90 seconds and between exercises will be 120 seconds. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Classification criteria of Takayasu's arteritis
- Sedentarism
Key exclusion criteria (4 listed)
- Peripherical arterial diseases
- Non-controlled cardiovascular diseases
- Neurological diseases
- Patients with walking problem
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 |
|---|---|---|
| Combined acute physical exercises (strength and aerobic)Patients will be submmitted to combined acute physical exercises (strength and aerobic) | Other | Physical exercises |
Primary outcome
Security of acute session of combined physical exercises
Time frame: One week before the exercises
Acute aerobic with strength muscle test exercise
9 secondary outcomes
Healthy Assessment Questionnaire (HAQ)
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Laboratory analysis (Serum levels of the protein C-reactive)
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Indian Takayasu's Arteritis Activity Score (ITAS 2010)
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Cardiopulmonary test
Time frame: Once (within 1 week before acute combined physical exercises)
Laboratory analysis (Erythrocyte rate sedimentation)
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 1
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 2
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 3
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
Strength muscle tests 4
Time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
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 30 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Samuel K Shinjo principal investigator
Universidade de Sao Paulo - Rheumatology Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined acute physical exercises (strength and aerobic) in people with Physical Activity and Takayasu Arteritis, run by University of Sao 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 2 inclusion and 4 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 30 Apr 2021. 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.
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?
Security of acute session of combined physical exercises (time frame: One week before the exercises). 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 30 Apr 2021.