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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04868331
Other study ID # 2019-02-52-SRG190201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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