Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Evaluation of Cardiovascular Responses in Adolescent Idiopathic Scoliosis (AIS) Girls Performing E-Fit Exercise Intervention: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868331
• Other study ID #: 2019-02-52-SRG190201
• Status: Completed
• Phase: N/A
• Start date: May 18, 2021
• Est. completion date: March 12, 2022

Study information

• Verified date: May 2022
• Source: Tung Wah College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 12, 2022
• Est. primary completion date: March 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Behavioral:
• Exercise
Two trials of 7-min High Intensity Interval Training (HIIT) with 12 different exercises. Each exercise lasts for 30 seconds continuously with 10 seconds rest interval.

Locations

Country	Name	City	State
Hong Kong	Tung Wah College	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Tung Wah College	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory gas measurement	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).	Day 1
Primary	Blood Pressure	Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.	Day 1
Primary	Heart rate	Heart rate (bpm) will be measured using a fingertip oximeter.	Day 1
Primary	Oximetry	Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.	Day 1
Secondary	Maturity assessment	Sexual maturity using Tanner Scale and onset of menarche will be measured.	Day 1
Secondary	Modified Baecke Questionnaire	Habitual physical activity level will be assessed by self-administered questionnaire.	Day 1
Secondary	Physical Activity Rating Questionnaire for Children and Youth (PARCY)	Physical activity level and intensity will be assessed by self-administered questionnaire.	Day 1
Secondary	Body height	Body height (cm) will be measured with standard stadiometry techniques.	Day 1
Secondary	Sitting height	Sitting height (cm) will be measured with standard stadiometry techniques.	Day 1
Secondary	Arm Span	Arm span (cm) will be measured with standard stadiometry techniques.	Day 1
Secondary	Body Composition	Percentage body fat (%), body weight (kg), lean muscle mass (kg) will be assessed using Bioelectric Impedance Analysis.	Day 1