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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2019-08-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)

NCT01108211

Scoliosis Bone Diseases, Metabolic

COMPLETED PHASE3

6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation

NCT02904421

Scoliosis Vitamin D Bone

COMPLETED

Screening and Intervention for AIS in Haikou, Hainan Province, China

NCT05466383

AIS

RECRUITING NA

Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls

NCT00979511

Osteoporosis

COMPLETED NA

Bone Development in Adolescent Girls: Effects of Calcium and Exercise

NCT00063011

Osteoporosis

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Idiopathic Scoliosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise intervention group

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No