Clinical trial NCT03157570: Effects of Home Exercise Intervention on Bone Density, Muscle Functions, QoL, and Curve Progression in Girls With AIS
Official title: Effects of Home Exercise Intervention on Bone Density, Muscle Functions, Quality of Life, and Curve Progression in Girls With Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in BMD after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in Muscle mass after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in Anthropometric measurements after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in BMC after completion of exercise
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in clinical features after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in clinical features 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in muscle strength after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in muscle strength 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in muscle endurance after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in muscle endurance 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in aerobic fitness after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in aerobic fitness 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in quality of life after completion of exercise
timeFrame: Baseline and 6 months
measure: Change in quality of life 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in BMD 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in BMC 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in muscle mass 1 year after completion of exercise
timeFrame: Baseline and 18 months
measure: Change in Anthropometric measurements 1 year after completion of exercise
timeFrame: Baseline and 18 months
Other outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Dropout rate
timeFrame: 6 months
measure: Dietary intake measures
timeFrame: Baseline, 6 months 18 months
measure: Physical activity measures
timeFrame: Baseline, 6 months 18 months
measure: Maturity assessment
timeFrame: Baseline, 6 months 18 months
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: