Adolescent Idiopathic Scoliosis
Conditions
Brief 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. 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).
Interventions
BEHAVIORALExercise
7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval)
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Muscle mass after completion of exercise | 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 BMD after completion of exercise | 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 BMC after completion of exercise | 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. |
| Change in Anthropometric measurements after completion of exercise | Baseline and 6 months | Body height, weight, sitting height, and arm span will be measured with standard stadiometry techniques. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in muscle strength 1 year after completion of exercise | Baseline and 18 months | 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. |
| Change in muscle endurance after completion of exercise | Baseline and 6 months | 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. |
| Change in muscle endurance 1 year after completion of exercise | Baseline and 18 months | 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. |
| Change in aerobic fitness after completion of exercise | Baseline and 6 months | 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. |
| Change in clinical features after completion of exercise | Baseline and 6 months | 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. |
| Change in clinical features 1 year after completion of exercise | Baseline and 18 months | 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. |
| Change in muscle strength after completion of exercise | Baseline and 6 months | 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. |
| Change in quality of life 1 year after completion of exercise | Baseline and 18 months | 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). |
| Change in BMD 1 year after completion of exercise | Baseline and 18 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 BMC 1 year after completion of exercise | Baseline and 18 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. |
| Change in muscle mass 1 year after completion of exercise | Baseline and 18 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 1 year after completion of exercise | Baseline and 18 months | Body height, weight, sitting height, and arm span will be measured with standard stadiometry techniques. |
| Change in aerobic fitness 1 year after completion of exercise | Baseline and 18 months | 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. |
| Change in quality of life after completion of exercise | Baseline and 6 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 6 months | 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. |
| Physical activity measures | Baseline, 6 months 18 months | 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. |
| Dietary intake measures | Baseline, 6 months 18 months | 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. |
| Dropout rate | 6 months | 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. |
| Maturity assessment | Baseline, 6 months 18 months | 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. |
Countries
Hong Kong
Outcome results
None listed