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

NCT03157570 | Completed

• 1 other identifier: AISE_20170407
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Change in clinical features after completion of exercise

  Baseline and 6 months

• Change in clinical features 1 year after completion of exercise

  Baseline and 18 months

• Change in muscle strength after completion of exercise

  Baseline and 6 months

• Change in muscle strength 1 year after completion of exercise

  Baseline and 18 months

• Change in muscle endurance after completion of exercise

  Baseline and 6 months

Other Outcomes (5)

• Recruitment rate

  6 months

• Dropout rate

  6 months

• Dietary intake measures

  Baseline, 6 months 18 months

Study Arms (2)

Exercise intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group have no intervention and receives only standard care.

Interventions

Exercise BEHAVIORAL

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

Exercise intervention group

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Cobb Angle greater or equal to 15°
• Newly diagnosed at the Scoliosis Clinic without prior treatment
• Cleared for physical activity by doctor

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, 0, Hong Kong

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 17, 2017
• Study Start: July 19, 2017
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

HK (1)