An interventional study of Exercise in Adolescent Idiopathic Scoliosis, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to female participants aged 11 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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).
Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
The control group have no intervention and receives only standard care.
7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 18 months
Recruitment rate
The recruitment rate will be calculated based on the number of eligible subjects invited to the study and the number of eligible subjects agreed to participate.
Time frame: 6 months
Dropout rate
The dropout rates for the intervention and control groups will be calculated based on the number of recruited subjects in each group and the number of recruited subjects who failed to complete the 6-month exercise and complete all follow-up.
Time frame: 6 months
Dietary intake measures
Evaluation of habitual dietary intake will be based on retrospective means of assessment. A modified Food Frequency Questionnaire (FFQ) based on data obtained in the Hong Kong Adult Dietary Survey in 1995 will be used. The FFQ had been validated with the basal metabolic rate calculation and the 24-hour sodium/creatinine and potassium/creatinine analysis. Subjects will be asked about their usual frequency and consumption in the past twelve months from the food list. Standard portion size will be listed and a food photo album is provided to assist assessment. Any use of supplements will also be recorded. Daily nutrient intake is calculated by the Food Processor Nutrition analysis and Fitness software version 8.0 (Esha Research, Salem, USA), with addition of composition of some local foods based on food composition table from China.
Time frame: Baseline, 6 months 18 months
Physical activity measures
Physical activity level will be assessed with a physical activity bracelet and questionnaire. The subjects will be asked to wear the physical activity bracelet every day during the study period, thus provide an objective assessment of the physical activity of the wearer. Physical activity level of the subjects will also be assessed with the modified Baecke questionnaire adapted from Pols et al.
Time frame: Baseline, 6 months 18 months
Maturity assessment
Sexual maturity level including the breast development, onset of menarche, pubic hair distribution will be graded with standard Tanners Scale using the established and validated protocols.
Time frame: Baseline, 6 months 18 months
Ran from Jul 2017 to primary completion in Aug 2019, 25 months.
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