Effects of Home Exercise Intervention on Bone Density, Muscle Functions, QoL, and Curve Progression in Girls With AIS

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Home Exercise Intervention on Bone Density, Muscle Functions, Quality of Life, and Curve Progression in Girls With Adolescent Idiopathic Scoliosis

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cobb Angle greater or equal to 15° Newly diagnosed at the Scoliosis Clinic without prior treatment Cleared for physical activity by doctor Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention group<br>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. | Behavioral: Exercise<br>* 7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval)<br>|
| No Intervention: Control group<br>The control group have no intervention and receives only standard care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | Baseline and 18 months |