Adolescent Idiopathic ScoliosisNCT04868331
Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls
A study testing Exercise in people with Adolescent Idiopathic Scoliosis, run by Tung Wah College at 1 site in Hong Kong.
Trial summary
The aims of this pilot study are to determine the metabolic demand and exercise intensity level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the same way as compared to healthy controls. Read more about this study
- Who is it for?
- Ages 10 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 May 2021to 12 Mar 2022
- 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 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Cobb angle greater or equal to 15 degree
- Cleared for physical activity by doctor
Who cannot join
- Cobb angle greater or equal to 40 degree, or
- Scoliosis with any known etiology, scoliosis with skeletal dysplasia, know endocrine and connective tissue abnormalities, or
- Known heart condition or other diseases that could affect the safety of exercise, or
- Eating disorders or GI malabsorption disorders, or
- Currently taking medication that affects bone or muscle metabolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cardiovascular Responses in Adolescent Idiopathic Scoliosis (AIS) Girls Performing E-Fit Exercise Intervention: a Pilot Study
The aims of this pilot study are to determine the metabolic demand and exercise intensity level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the same way as compared to healthy controls. We hypothesise that 1) the metabolic demand and exercise intensity of E-Fit exercise intervention is equivalent to moderate-to-vigorous level; and 2) AIS girls have different cardiovascular responses as compared to healthy controls
Read the detailed description
AIS girls and age- and gender-matched healthy controls will perform the E-Fit exercise intervention for two trials and gas exchange parameters including oxygen consumption (VO2) and carbon dioxide production (VCO2) will be taken continuously during the exercise. Comparison of VO2 and VCO2 between AIS and healthy controls when performing E-Fit exercise will be made.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Two trials of 7-min High Intensity Interval Training (HIIT) with 12 different exercises. Each exercise lasts for 30 seconds continuously with 10 seconds rest interval.
| Study group | Role | What they receive |
|---|---|---|
| AIS girls | Experimental | Girls between the ages of 10-16 will be recruited if they have a diagnosis of AIS. Receives: Behavioral: Exercise |
| Healthy Controls | Active comparator | Healthy adolescent girls matched in age and puberty maturity without spinal deformity Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory gas measurement
Breath-by-breath measurement of cardiorespiratory and gas exchange parameters to analyse oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min).
Measured: Day 1
Blood Pressure
Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.
Measured: Day 1
Heart rate
Heart rate (bpm) will be measured using a fingertip oximeter.
Measured: Day 1
Oximetry
Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.
Measured: Day 1
Secondary outcomes (7)
Maturity assessment
Sexual maturity using Tanner Scale and onset of menarche will be measured.
Measured: Day 1
Modified Baecke Questionnaire
Habitual physical activity level will be assessed by self-administered questionnaire.
Measured: Day 1
Physical Activity Rating Questionnaire for Children and Youth (PARCY)
Physical activity level and intensity will be assessed by self-administered questionnaire.
Measured: Day 1
Body height
Body height (cm) will be measured with standard stadiometry techniques.
Measured: Day 1
Sitting height
Sitting height (cm) will be measured with standard stadiometry techniques.
Measured: Day 1
Arm Span
Arm span (cm) will be measured with standard stadiometry techniques.
Measured: Day 1
Body Composition
Percentage body fat (%), body weight (kg), lean muscle mass (kg) will be assessed using Bioelectric Impedance Analysis.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start18 May 2021
- Primary completion12 Mar 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Rufina Lau, Tung Wah College
- Investigators
- Rufina Lau, MSc, Principal investigator, Tung Wah College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868331
- Sponsor's protocol ID
- 2019-02-52-SRG190201
- Status last verified
- May 2022
- First submitted
- 24 Mar 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Responses in Adolescent Idiopathic Scoliosis (AIS) Girls Performing E-Fit Exercise Intervention: a Pilot Study
- ClinicalTrials.gov ID
- NCT04868331
- Acronym / sponsor ID
- 2019-02-52-SRG190201
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 18 May 2021 (actual)
- Primary completion
- 12 Mar 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 30 Apr 2021 (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.
The aims of this pilot study are to determine the metabolic demand and exercise intensity level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the same way as compared to healthy controls. We hypothesise that 1) the metabolic demand and exercise intensity of E-Fit exercise intervention is equivalent to moderate-to-vigorous level; and 2) AIS girls have different cardiovascular responses as compared to healthy controls
Detailed description
AIS girls and age- and gender-matched healthy controls will perform the E-Fit exercise intervention for two trials and gas exchange parameters including oxygen consumption (VO2) and carbon dioxide production (VCO2) will be taken continuously during the exercise. Comparison of VO2 and VCO2 between AIS and healthy controls when performing E-Fit exercise will be made.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIS girls | Experimental | Behavioral: ExerciseGirls between the ages of 10-16 will be recruited if they have a diagnosis of AIS. |
| Healthy Controls | Active comparator | Behavioral: ExerciseHealthy adolescent girls matched in age and puberty maturity without spinal deformity |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Cobb angle greater or equal to 15 degree
- Cleared for physical activity by doctor
Key exclusion criteria (5 listed)
- Cobb angle greater or equal to 40 degree, or
- Scoliosis with any known etiology, scoliosis with skeletal dysplasia, know endocrine and connective tissue abnormalities, or
- Known heart condition or other diseases that could affect the safety of exercise, or
- Eating disorders or GI malabsorption disorders, or
- Currently taking medication that affects bone or muscle metabolism
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 |
|---|---|---|
| ExerciseTwo trials of 7-min High Intensity Interval Training (HIIT) with 12 different exercises. Each exercise lasts for 30 seconds continuously with 10 seconds rest interval. | Behavioural | AIS girls, Healthy Controls |
Primary outcome
Respiratory gas measurement
Time frame: Day 1
Breath-by-breath measurement of cardiorespiratory and gas exchange parameters to analyse oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min).
Blood Pressure
Time frame: Day 1
Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.
Heart rate
Time frame: Day 1
Heart rate (bpm) will be measured using a fingertip oximeter.
Oximetry
Time frame: Day 1
Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.
7 secondary outcomes
Maturity assessment
Time frame: Day 1
Modified Baecke Questionnaire
Time frame: Day 1
Physical Activity Rating Questionnaire for Children and Youth (PARCY)
Time frame: Day 1
Body height
Time frame: Day 1
Sitting height
Time frame: Day 1
Arm Span
Time frame: Day 1
Body Composition
Time frame: Day 1
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 11 May 2022.
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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.
Rufina Lau, MSc principal investigator
Tung Wah College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Adolescent Idiopathic Scoliosis, run by Tung Wah College at 1 site in Hong Kong.
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 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: finished, as of the sponsor's last update on 11 May 2022. 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 Hong Kong. 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?
Respiratory gas measurement (time frame: Day 1). The study lists 4 primary outcomes in all. 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 11 May 2022.