Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

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

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

Study Overview

• Status: Completed
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Behavioral: Exercise

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Tung Wah College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIS girls; Girls between the ages of 10-16 will be recruited if they have a diagnosis of AIS.	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.
Active Comparator: Healthy Controls; Healthy adolescent girls matched in age and puberty maturity without spinal deformity	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood Pressure	Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.	Day 1
Heart rate	Heart rate (bpm) will be measured using a fingertip oximeter.	Day 1
Oximetry	Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tung Wah College
• Collaborators: Chinese University of Hong Kong
• Investigators: Principal Investigator: Rufina Lau, MSc, Tung Wah College

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2021
• Primary Completion (Actual): March 12, 2022
• Study Completion (Actual): March 12, 2022

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2019-02-52-SRG190201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No