ScoliosisNCT02413788
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
A study testing aerobic exercise, combined exercise and treadmill in people with Scoliosis and Adolescent Scoliosis, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Inflammatory markers have been analyzed in several diseases of unknown etiology, in the expectation of increasing therapeutic perspectives. This possibility arises from the different levels of tissue injury with low-grade chronic inflammation that have been observed in studies in which the markers were not evaluated… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis, Adolescent Scoliosis
- What is being tested?
- aerobic exercise, combined exercise and treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Mar 2016
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- thoracic curvature ≥ 45 degrees
- indication for surgical treatment of spinal deformity
- absence of pulmonary, cardiac, articular or neurological disorder, atopic dermatitis and previous or current allergy
- agree part in the research with a assent statement and the person responsible with the consent form and informed
Who cannot join
- acknowledged chronic liver or kidney inflammatory disease
- use of corticosteroids, acetylsalicylic acid or other nonhormonal anti-inflammatory clinical or laboratorial evidence of infection
- severe obesity
Trial locations and contacts
1 site in 1 country.
About this study
Inflammatory markers have been analyzed in several diseases of unknown etiology, in the expectation of increasing therapeutic perspectives. This possibility arises from the different levels of tissue injury with low-grade chronic inflammation that have been observed in studies in which the markers were not evaluated traditionally, and today have influenced clinical management.
The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS before and after aerobic and combined exercise training.
Read the detailed description
Inflammatory markers have not been evaluated in adolescent idiopathic scoliosis (AIS), but this deformity potentially involves various musculoskeletal structures permanently, which justifies the analysis. A low-grade chronic inflammation may be related to the lower capacity in exercise performance observed in this population, which must be stimulated to perform standardized physical activity.
- Conditions
- Scoliosis, Adolescent Scoliosis
- Being tested
- aerobic exercise, combined exercise, treadmill
- Keywords
- adolescent idiopathic scoliosis, inflammatory markers, exercise
- Medical subject headings
- Scoliosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate)
combined exerciseOther
aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate); resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs
treadmillDevice
| Study group | Role | What they receive |
|---|---|---|
| combined group (treadmill and resisted) | Experimental | - 10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) and resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs (36 sessions) Receives: Other: combined exercise; Device: treadmill |
| aerobic group (treadmill) | Active comparator | 10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) for 36 sessions Receives: Other: aerobic exercise; Device: treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 1
Inflammatory Markers
Measured: change from baseline in interleukin 1 at 3 months
interleukin 6
Inflammatory Markers
Measured: change from baseline in interleukin 6 at 3 months
interleukin 8
Inflammatory Markers
Measured: change from baseline in interleukin 8 at 3 months
Secondary outcomes (15)
distance in six-minute walk test
analysis of distance
Measured: change from baseline in distance at 3 months
oxygen saturation in six-minute walk test
analysis of oxygen saturation at end of test
Measured: change from baseline in oxygen saturation at 3 months
systolic blood pressure in six-minute walk test
analysis of systolic blood pressure at end of test
Measured: change from baseline in systolic blood pressure at 3 months
diastolic blood pressure in six-minute walk test
analysis of diastolic blood pressure at end of test
Measured: change from baseline in diastolic blood pressure at 3 months
heart rate in six-minute walk test
analysis of heart rate at end of test
Measured: change from baseline in heart rate at 3 months
respiratory frequency in six-minute walk test
analysis of respiratory frequency at end of test
Measured: change from baseline in respiratory frequency at 3 months
Borg scale in six-minute walk test
analysis of Borg scale at end of test
Measured: change from baseline in Borg scale at 3 months
forced vital capacity (FVC)
analyzed in liters or % of predicted of lung capacity variation from baseline at 3 months
Measured: change from baseline at 3 months
maximal inspiratory pressure (MIP)
analysis of maximal inspiratory pressure variation (cmH2O)
Measured: change from baseline at 3 months
maximal expiratory pressure (MEP)
analysis of maximal expiratory pressure variation (cmH2O)
Measured: change from baseline at 3 months
peak expiratory flow
peak expiratory flow variation analysis in liters / minute (l/min)
Measured: change from baseline at 3 months
forced expiratory volume in the first second (FEV1)
analyzed in liters or % of predicted of lung volume variation from baseline at 3 months
Measured: change from baseline at 3 months
forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC)
Analysis (%) of the relationship between FEV1 and FVC with variation from baseline at 3 months
Measured: change from baseline at 3 months
FORCED EXPIRATORY FRACTION (FEF25-75%)
analyzed in milliliters (ml) of lung volume variation from baseline at 3 months
Measured: change from baseline at 3 months
FORCED EXPIRATORY FRACTION (FEF25-75%) / forced vital capacity (FVC)
Analysis (%) of the relationship between FEV1 and FVC with variation from baseline at 3 months
Measured: change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ScoliosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Profa. Dra. Vera Lúcia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413788
- Sponsor's protocol ID
- Fcmscsp
- Status last verified
- Nov 2019
- First submitted
- 31 Mar 2015
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xavier VB, Avanzi O, de Carvalho BDMC, Alves VLDS. Combined aerobic and resistance training improves respiratory and exercise outcomes more than aerobic training in adolescents with idiopathic scoliosis: a randomised trial. J Physiother. 2020 Jan;66(1):33-38. doi: 10.1016/j.jphys.2019.11.012. Epub 2019 Dec 16.
PubMed 31859153
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02413788
- Acronym / sponsor ID
- Fcmscsp
- Conditions
- Scoliosis, Adolescent Scoliosis
- Keywords
- adolescent idiopathic scoliosis, inflammatory markers, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Apr 2015 (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.
Inflammatory markers have been analyzed in several diseases of unknown etiology, in the expectation of increasing therapeutic perspectives. This possibility arises from the different levels of tissue injury with low-grade chronic inflammation that have been observed in studies in which the markers were not evaluated traditionally, and today have influenced clinical management.
The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS before and after aerobic and combined exercise training.
Detailed description
Inflammatory markers have not been evaluated in adolescent idiopathic scoliosis (AIS), but this deformity potentially involves various musculoskeletal structures permanently, which justifies the analysis. A low-grade chronic inflammation may be related to the lower capacity in exercise performance observed in this population, which must be stimulated to perform standardized physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined group (treadmill and resisted) | Experimental | Other: combined exercise, Device: treadmill- 10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) and resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs (36 sessions) |
| aerobic group (treadmill) | Active comparator | Other: aerobic exercise, Device: treadmill10 minutes of warming, aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) for 36 sessions |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- thoracic curvature ≥ 45 degrees
- indication for surgical treatment of spinal deformity
- absence of pulmonary, cardiac, articular or neurological disorder, atopic dermatitis and previous or current allergy
- agree part in the research with a assent statement and the person responsible with the consent form and informed
Key exclusion criteria (3 listed)
- acknowledged chronic liver or kidney inflammatory disease
- use of corticosteroids, acetylsalicylic acid or other nonhormonal anti-inflammatory clinical or laboratorial evidence of infection
- severe obesity
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 |
|---|---|---|
| aerobic exerciseaerobic training 40 minutes on a treadmill (60-80% of maximum heart rate) | Other | aerobic group (treadmill) |
| combined exerciseaerobic training 40 minutes on a treadmill (60-80% of maximum heart rate); resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs | Other | combined group (treadmill and resisted) |
| treadmill | Device | aerobic group (treadmill), combined group (treadmill and resisted) |
Primary outcome
interleukin 1
Time frame: change from baseline in interleukin 1 at 3 months
Inflammatory Markers
interleukin 6
Time frame: change from baseline in interleukin 6 at 3 months
Inflammatory Markers
interleukin 8
Time frame: change from baseline in interleukin 8 at 3 months
Inflammatory Markers
15 secondary outcomes
distance in six-minute walk test
Time frame: change from baseline in distance at 3 months
oxygen saturation in six-minute walk test
Time frame: change from baseline in oxygen saturation at 3 months
systolic blood pressure in six-minute walk test
Time frame: change from baseline in systolic blood pressure at 3 months
diastolic blood pressure in six-minute walk test
Time frame: change from baseline in diastolic blood pressure at 3 months
heart rate in six-minute walk test
Time frame: change from baseline in heart rate at 3 months
respiratory frequency in six-minute walk test
Time frame: change from baseline in respiratory frequency at 3 months
Borg scale in six-minute walk test
Time frame: change from baseline in Borg scale at 3 months
forced vital capacity (FVC)
Time frame: change from baseline at 3 months
maximal inspiratory pressure (MIP)
Time frame: change from baseline at 3 months
maximal expiratory pressure (MEP)
Time frame: change from baseline at 3 months
peak expiratory flow
Time frame: change from baseline at 3 months
forced expiratory volume in the first second (FEV1)
Time frame: change from baseline at 3 months
forced expiratory volume in the first second (FEV1) / forced vital capacity (FVC)
Time frame: change from baseline at 3 months
FORCED EXPIRATORY FRACTION (FEF25-75%)
Time frame: change from baseline at 3 months
FORCED EXPIRATORY FRACTION (FEF25-75%) / forced vital capacity (FVC)
Time frame: change from baseline at 3 months
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 6 Sep 2023.
- Derived from this study: PubMed 31859153Xavier VB, Avanzi O, de Carvalho BDMC, Alves VLDS. Combined aerobic and resistance training improves respiratory and exercise outcomes more than aerobic training in adolescents with idiopathic scoliosis: a randomised trial. J Physiother. 2020 Jan;66(1):33-38. doi: 10.1016/j.jphys.2019.11.012. Epub 2019 Dec 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise, combined exercise and treadmill in people with Scoliosis and Adolescent Scoliosis, run by Faculdade de Ciências Médicas da Santa Casa de 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 4 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 6 Sep 2023. 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?
interleukin 1 (time frame: change from baseline in interleukin 1 at 3 months). The study lists 3 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 NCT02413788, which also lists 1 linked publication.
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 6 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.