search
Back to results

Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Exercise
Sponsored by
Tung Wah College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

10 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tung Wah College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AIS girls

Healthy Controls

Arm Description

Girls between the ages of 10-16 will be recruited if they have a diagnosis of AIS.

Healthy adolescent girls matched in age and puberty maturity without spinal deformity

Outcomes

Primary Outcome Measures

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).
Blood Pressure
Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.
Heart rate
Heart rate (bpm) will be measured using a fingertip oximeter.
Oximetry
Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.

Secondary Outcome Measures

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

Full Information

First Posted
March 24, 2021
Last Updated
May 9, 2022
Sponsor
Tung Wah College
Collaborators
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT04868331
Brief Title
Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls
Official Title
Evaluation of Cardiovascular Responses in Adolescent Idiopathic Scoliosis (AIS) Girls Performing E-Fit Exercise Intervention: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
March 12, 2022 (Actual)
Study Completion Date
March 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tung Wah College
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIS girls
Arm Type
Experimental
Arm Description
Girls between the ages of 10-16 will be recruited if they have a diagnosis of AIS.
Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
Healthy adolescent girls matched in age and puberty maturity without spinal deformity
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory gas measurement
Description
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).
Time Frame
Day 1
Title
Blood Pressure
Description
Blood pressure (mmHg) will be measured using an electronic sphygmomanometer.
Time Frame
Day 1
Title
Heart rate
Description
Heart rate (bpm) will be measured using a fingertip oximeter.
Time Frame
Day 1
Title
Oximetry
Description
Peripheral capillary oxygen saturation (%) will be measured using a fingertip oximeter.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Maturity assessment
Description
Sexual maturity using Tanner Scale and onset of menarche will be measured.
Time Frame
Day 1
Title
Modified Baecke Questionnaire
Description
Habitual physical activity level will be assessed by self-administered questionnaire.
Time Frame
Day 1
Title
Physical Activity Rating Questionnaire for Children and Youth (PARCY)
Description
Physical activity level and intensity will be assessed by self-administered questionnaire.
Time Frame
Day 1
Title
Body height
Description
Body height (cm) will be measured with standard stadiometry techniques.
Time Frame
Day 1
Title
Sitting height
Description
Sitting height (cm) will be measured with standard stadiometry techniques.
Time Frame
Day 1
Title
Arm Span
Description
Arm span (cm) will be measured with standard stadiometry techniques.
Time Frame
Day 1
Title
Body Composition
Description
Percentage body fat (%), body weight (kg), lean muscle mass (kg) will be assessed using Bioelectric Impedance Analysis.
Time Frame
Day 1

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rufina Lau, MSc
Organizational Affiliation
Tung Wah College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tung Wah College
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

We'll reach out to this number within 24 hrs