Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

Not Applicable

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Behavioral: Exercise

• Registration Number: NCT04868331
• Lead Sponsor: Tung Wah College

Brief Summary

The aims of this pilot study are to determine the metabolic demand and exercise intensity level of E-Fit exercise intervention by evaluating the cardiovascular responses in AIS girls and whether the cardiovascular responses for AIS girls performing E-Fit will behave in the same way as compared to healthy controls. We hypothesise that 1) the metabolic demand and exercise intensity of E-Fit exercise intervention is equivalent to moderate-to-vigorous level; and 2) AIS girls have different cardiovascular responses as compared to healthy controls

Detailed Description

AIS girls and age- and gender-matched healthy controls will perform the E-Fit exercise intervention for two trials and gas exchange parameters including oxygen consumption (VO2) and carbon dioxide production (VCO2) will be taken continuously during the exercise. Comparison of VO2 and VCO2 between AIS and healthy controls when performing E-Fit exercise will be made.

Study Timeline

• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Study Start: 2021-05-18
• Primary Completion: 2022-03-12
• Study Completion: 2022-03-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Cobb angle greater or equal to 15 degree
• Cleared for physical activity by doctor

Exclusion Criteria

• Cobb angle greater or equal to 40 degree, or
• Scoliosis with any known etiology, scoliosis with skeletal dysplasia, know endocrine and connective tissue abnormalities, or
• Known heart condition or other diseases that could affect the safety of exercise, or
• Eating disorders or GI malabsorption disorders, or
• Currently taking medication that affects bone or muscle metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIS girls	Exercise	Girls between the ages of 10-16 will be recruited if they have a diagnosis of AIS.
Healthy Controls	Exercise	Healthy adolescent girls matched in age and puberty maturity without spinal deformity

Primary Outcome Measures

Name	Time	Method
Oximetry	Day 1	Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.
Respiratory gas measurement	Day 1	Breath-by-breath measurement of cardiorespiratory and gas exchange parameters to analyse oxygen consumption (VO2 in ml/min) and carbon dioxide production (VCO2 in ml/min).
Blood Pressure	Day 1	Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.
Heart rate	Day 1	Heart rate (bpm) will be measured using a fingertip oximeter.

Secondary Outcome Measures

Name	Time	Method
Modified Baecke Questionnaire	Day 1	Habitual physical activity level will be assessed by self-administered questionnaire.
Sitting height	Day 1	Sitting height (cm) will be measured with standard stadiometry techniques.
Arm Span	Day 1	Arm span (cm) will be measured with standard stadiometry techniques.
Body Composition	Day 1	Percentage body fat (%), body weight (kg), lean muscle mass (kg) will be assessed using Bioelectric Impedance Analysis.
Maturity assessment	Day 1	Sexual maturity using Tanner Scale and onset of menarche will be measured.
Physical Activity Rating Questionnaire for Children and Youth (PARCY)	Day 1	Physical activity level and intensity will be assessed by self-administered questionnaire.
Body height	Day 1	Body height (cm) will be measured with standard stadiometry techniques.

Trial Locations

Locations (1)

Tung Wah College; 🇭🇰 Hong Kong, Hong Kong