Adolescent Idiopathic ScoliosisNCT03157570
Effects of Home Exercise Intervention on Bone Density, Muscle Functions, QoL, and Curve Progression in Girls With AIS
A study testing Exercise in people with Adolescent Idiopathic Scoliosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Studies with exercise intervention aimed to improve the bone health and muscle functions in patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass were associated with curve severity and occurrence of AIS. Read more about this study
- Who is it for?
- Ages 11 to 14 years, women only
- 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
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Jul 2017to 20 Aug 2019
- 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 11 to 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Cobb Angle greater or equal to 15°
- Newly diagnosed at the Scoliosis Clinic without prior treatment
- Cleared for physical activity by doctor
Who cannot join
- Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
- Known endocrine and connective tissue abnormalities, or
- Known heart condition or other diseases that could affect the safety of exercise
- 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: Effects of Home Exercise Intervention on Bone Density, Muscle Functions, Quality of Life, and Curve Progression in Girls With Adolescent Idiopathic Scoliosis
Studies with exercise intervention aimed to improve the bone health and muscle functions in patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass were associated with curve severity and occurrence of AIS. Weight-bearing exercise that aimed to improve musculoskeletal and metabolic health could enhance bone health and muscle mass, and could provide a feasible alternative conservative treatment to prevent curve progression as well as the quality of life in AIS girls. This is a pilot feasibility study for future large randomized controlled trial (RCT) aiming at determining the effects of home based exercise program on improving bone mineral density (BMD), muscle mass and functions, quality of life (QoL), and prevent curve progression in skeletally immature girls with adolescent idiopathic scoliosis (AIS).
- 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
7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval)
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention group | Experimental | The exercise group will participate in a 6-month home exercise along with demonstration videos. The exercise training program is an online 7-minute high-intensity interval training (HIIT) exercise through the integrated application of an exercise provision website and mobile Apps. The program will comprise of a broad range of exercises, applied at varying speeds and directions in order to increase heart rate, and to load a variety of muscle groups and skeletal regions in the upper and lower body. The exercise will be performed 5 days per week with the remaining 2 days as rest days. Receives: Behavioral: Exercise |
| Control group | No intervention | The control group have no intervention and receives only standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMD after completion of exercise
Areal BMD (g/cm2) of non-dominant femoral neck and greater trochanter, and whole body BMD will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement. Quality assurance is performed by daily calibration against the standard phantoms provided by the manufacturer, with a precision error of 1.9% for BMD value for patient scan and <1.0% for whole body phantom scan.
Measured: Baseline and 6 months
Change in Muscle mass after completion of exercise
Muscle mass will be measurement by whole body less head (WBLH) scan with DXA (Horizon, Hologic Inc., USA). DXA is the current golden standard to the measurement of body composition. Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
Measured: Baseline and 6 months
Change in Anthropometric measurements after completion of exercise
Body height, weight, sitting height, and arm span will be measured with standard stadiometry techniques.
Measured: Baseline and 6 months
Change in BMC after completion of exercise
BMC (g/cm) of non-dominant femoral neck and greater trochanter, and whole body BMC will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
Measured: Baseline and 6 months
Secondary outcomes (14)
Change in clinical features after completion of exercise
A long standard standing postero-anterior (PA) whole spine radiograph will be used for grading curve severity in terms of Cobb angle according to the standard Cobb method. Risser sign, curve level and apex, and curve type will be recorded as in any standard assessment of scoliosis patients.
Measured: Baseline and 6 months
Change in clinical features 1 year after completion of exercise
A long standard standing postero-anterior (PA) whole spine radiograph will be used for grading curve severity in terms of Cobb angle according to the standard Cobb method. Risser sign, curve level and apex, and curve type will be recorded as in any standard assessment of scoliosis patients.
Measured: Baseline and 18 months
Change in muscle strength after completion of exercise
Legs, back, abdominal, and handgrip muscle strength will be assessed with dynamometer. The tests will be performed 3 times with 1 familiarization effort and 2 maximal effort, and the highest scores will be used for analysis.
Measured: Baseline and 6 months
Change in muscle strength 1 year after completion of exercise
Legs, back, abdominal, and handgrip muscle strength will be assessed with dynamometer. The tests will be performed 3 times with 1 familiarization effort and 2 maximal effort, and the highest scores will be used for analysis.
Measured: Baseline and 18 months
Change in muscle endurance after completion of exercise
Isometric squat test, Biering-Sorensen test, and isometric curl-up test will be used to assess the quadriceps, back and abdominal muscle endurance. The time (seconds) in which the subject maintained the position is recorded.
Measured: Baseline and 6 months
Change in muscle endurance 1 year after completion of exercise
Isometric squat test, Biering-Sorensen test, and isometric curl-up test will be used to assess the quadriceps, back and abdominal muscle endurance. The time (seconds) in which the subject maintained the position is recorded.
Measured: Baseline and 18 months
Change in aerobic fitness after completion of exercise
Aerobic fitness (estimated VO2max) of the subjects will be measured using sing-stage cycle ergometer sub-maximal test. Participants will be asked to sit on a cycle ergometer with 3-5 min warm up cycling at 150 kgm/min (25 Watt) workload, then workload will increase to 450-600 kgm/min (75-100 Watt) for another 6 minutes, in order to stimulate a submaximal exercise heart rate between 125-170 bpm. Estimated VO2max is then computed from the Astrand formula: VO2max = (workload x 2 + 300) * (200 - 73) / (exercise heart rate - 73)". Safety guidelines and procedures recommended by the ACSM will be followed.
Measured: Baseline and 6 months
Change in aerobic fitness 1 year after completion of exercise
Aerobic fitness (estimated VO2max) of the subjects will be measured using sing-stage cycle ergometer sub-maximal test. Participants will be asked to sit on a cycle ergometer with 3-5 min warm up cycling at 150 kgm/min (25 Watt) workload, then workload will increase to 450-600 kgm/min (75-100 Watt) for another 6 minutes, in order to stimulate a submaximal exercise heart rate between 125-170 bpm. Estimated VO2max is then computed from the Astrand formula: VO2max = (workload x 2 + 300) * (200 - 73) / (exercise heart rate - 73)". Safety guidelines and procedures recommended by the ACSM will be followed.
Measured: Baseline and 18 months
Change in quality of life after completion of exercise
The Quality of Life of the subjects will be assessed with the official Chinese version of Scoliosis Research Society-22 (SRS-22r) Questionnaire. SRS-22r is an internationally validated questionnaire that contains 22 questions organized in 5 domains covering different aspects of the quality of life of patients with scoliosis: function/activity, pain, self-image, mental health (5 items each), and satisfaction with treatment (2 items).
Measured: Baseline and 6 months
Change in quality of life 1 year after completion of exercise
The Quality of Life of the subjects will be assessed with the official Chinese version of Scoliosis Research Society-22 (SRS-22r) Questionnaire. SRS-22r is an internationally validated questionnaire that contains 22 questions organized in 5 domains covering different aspects of the quality of life of patients with scoliosis: function/activity, pain, self-image, mental health (5 items each), and satisfaction with treatment (2 items).
Measured: Baseline and 18 months
Change in BMD 1 year after completion of exercise
Areal BMD (g/cm2) of non-dominant femoral neck and greater trochanter, and whole body BMD will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement. Quality assurance is performed by daily calibration against the standard phantoms provided by the manufacturer, with a precision error of 1.9% for BMD value for patient scan and <1.0% for whole body phantom scan.
Measured: Baseline and 18 months
Change in BMC 1 year after completion of exercise
BMC (g/cm) of non-dominant femoral neck and greater trochanter, and whole body BMC will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
Measured: Baseline and 18 months
Change in muscle mass 1 year after completion of exercise
Muscle mass will be measurement by whole body less head (WBLH) scan with DXA (Horizon, Hologic Inc., USA). DXA is the current golden standard to the measurement of body composition. Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
Measured: Baseline and 18 months
Change in Anthropometric measurements 1 year after completion of exercise
Body height, weight, sitting height, and arm span will be measured with standard stadiometry techniques.
Measured: Baseline and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start19 Jul 2017
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
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.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man Shan Elisa Tam, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157570
- Sponsor's protocol ID
- AISE_20170407
- Status last verified
- Feb 2020
- First submitted
- 8 May 2017
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home Exercise Intervention on Bone Density, Muscle Functions, Quality of Life, and Curve Progression in Girls With Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03157570
- Acronym / sponsor ID
- AISE_20170407
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 17 May 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.
Studies with exercise intervention aimed to improve the bone health and muscle functions in patients with AIS were lacking. Evidence suggested that low bone mass and low muscle mass were associated with curve severity and occurrence of AIS. Weight-bearing exercise that aimed to improve musculoskeletal and metabolic health could enhance bone health and muscle mass, and could provide a feasible alternative conservative treatment to prevent curve progression as well as the quality of life in AIS girls. This is a pilot feasibility study for future large randomized controlled trial (RCT) aiming at determining the effects of home based exercise program on improving bone mineral density (BMD), muscle mass and functions, quality of life (QoL), and prevent curve progression in skeletally immature girls with adolescent idiopathic scoliosis (AIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention group | Experimental | Behavioral: ExerciseThe exercise group will participate in a 6-month home exercise along with demonstration videos. The exercise training program is an online 7-minute high-intensity interval training (HIIT) exercise through the integrated application of an exercise provision website and mobile Apps. The program will comprise of a broad range of exercises, applied at varying speeds and directions in order to increase heart rate, and to load a variety of muscle groups and skeletal regions in the upper and lower body. The exercise will be performed 5 days per week with the remaining 2 days as rest days. |
| Control group | No intervention | –The control group have no intervention and receives only standard care. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cobb Angle greater or equal to 15°
- Newly diagnosed at the Scoliosis Clinic without prior treatment
- Cleared for physical activity by doctor
Key exclusion criteria (5 listed)
- Scoliosis with any known etiology such as congenital scoliosis, neuromuscular scoliosis, scoliosis of metabolic etiology, scoliosis with skeletal dysplasia, or
- Known endocrine and connective tissue abnormalities, or
- Known heart condition or other diseases that could affect the safety of exercise
- 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 |
|---|---|---|
| Exercise7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval) | Behavioural | Exercise intervention group |
Primary outcome
Change in BMD after completion of exercise
Time frame: Baseline and 6 months
Areal BMD (g/cm2) of non-dominant femoral neck and greater trochanter, and whole body BMD will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement. Quality assurance is performed by daily calibration against the standard phantoms provided by the manufacturer, with a precision error of 1.9% for BMD value for patient scan and <1.0% for whole body phantom scan.
Change in Muscle mass after completion of exercise
Time frame: Baseline and 6 months
Muscle mass will be measurement by whole body less head (WBLH) scan with DXA (Horizon, Hologic Inc., USA). DXA is the current golden standard to the measurement of body composition. Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
Change in Anthropometric measurements after completion of exercise
Time frame: Baseline and 6 months
Body height, weight, sitting height, and arm span will be measured with standard stadiometry techniques.
Change in BMC after completion of exercise
Time frame: Baseline and 6 months
BMC (g/cm) of non-dominant femoral neck and greater trochanter, and whole body BMC will be measured by DXA (Horizon, Hologic Inc., USA). Standardized scanning procedure provided by the manufacturer will be followed to ensure unified and comparable measurement.
14 secondary outcomes
Change in clinical features after completion of exercise
Time frame: Baseline and 6 months
Change in clinical features 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in muscle strength after completion of exercise
Time frame: Baseline and 6 months
Change in muscle strength 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in muscle endurance after completion of exercise
Time frame: Baseline and 6 months
Change in muscle endurance 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in aerobic fitness after completion of exercise
Time frame: Baseline and 6 months
Change in aerobic fitness 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in quality of life after completion of exercise
Time frame: Baseline and 6 months
Change in quality of life 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in BMD 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in BMC 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in muscle mass 1 year after completion of exercise
Time frame: Baseline and 18 months
Change in Anthropometric measurements 1 year after completion of exercise
Time frame: Baseline and 18 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 28 Feb 2020.
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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 Exercise in people with Adolescent Idiopathic Scoliosis, run by Chinese University of Hong Kong 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 3 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 28 Feb 2020. 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?
Change in BMD after completion of exercise (time frame: Baseline and 6 months). 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 28 Feb 2020.