Cardiovascular Responses in Adolescent Idiopathic Scoliosis Girls

NCT04868331 | Completed DMC

• 1 other identifier: 2019-02-52-SRG190201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Maturity assessment

  Day 1

• Modified Baecke Questionnaire

  Day 1

• Physical Activity Rating Questionnaire for Children and Youth (PARCY)

  Day 1

• Body height

  Day 1

• Sitting height

  Day 1

Study Arms (2)

AIS girls

EXPERIMENTAL

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

Behavioral: Exercise

Healthy Controls

ACTIVE COMPARATOR

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

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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.

AIS girls; Healthy Controls

Eligibility Criteria

• Age: 10 Years - 16 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tung Wah College: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Tung Wah College

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rufina Lau, MSc

  Tung Wah College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 30, 2021
• Study Start: May 18, 2021
• Primary Completion: March 12, 2022
• Study Completion: March 12, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

HK (1)