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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157570
• Other study ID #: AISE_20170407
• Status: Completed
• Phase: N/A
• Start date: July 19, 2017
• Est. completion date: August 20, 2019

Study information

• Verified date: February 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Behavioral:
• Exercise
7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval)

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6 months
Other	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.	6 months
Other	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.	Baseline, 6 months 18 months
Other	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.	Baseline, 6 months 18 months
Other	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.	Baseline, 6 months 18 months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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