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Corestability Training in Overweight Children

Primary Purpose

Childhood Obesity, Child Obesity, Children, Only

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Corestability training
No Intervention
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Noncommunicable disease, Balance, Posture, Childhood obesity, Overweight

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children of age 8- 16 years old.
  2. Both Boys and Girls.
  3. Child with BMI-for-age percentile growth between 85th to less than 95th percentile.

Exclusion Criteria:

  1. Uncooperative participants.
  2. Upper or lower limb fracture or injury in recent 6 months.
  3. Any musculoskeletal or neurological disorder affecting core strength and balance.
  4. Refuse to participate because not able to understand the researcher instructions.
  5. Unable to attend the whole sessions during the research period.

Sites / Locations

  • Kanu Goyal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group (Core stability training (CST))

Control group

Arm Description

Core stability training (CST) consists of two levels: level 1- Mat exercises (includes abdominal muscle contraction, bridging,cat stretch,single leg circle and superman) and level 2- Swiss ball exercises (includes abdominal muscle contraction, bridging and squatting by using therapy ball). There will be three sets of 15 repetitions of each exercises. The first set will consist of 10 seconds hold period, follow by 12 seconds hold in second set and 15 seconds hold in third set respectively. The entire session will last for approximately 30 minutes.

Will not receive any kind of training.

Outcomes

Primary Outcome Measures

Foot pressure distribution
All overweight children will be asked to walk barefoot along a 5-.metre walkway using Harris mat pressure distribution platform which will be placed on a firm, level surface, in the centre of walkway. Children will be ensured to step on the Harris mat without pause, first with one foot and then repeat the same procedure with the other foot at constant speed. Foot markings then analyzed by using
Single limb stance
The children will be instructed to stand on the dominant leg with non dominant leg flexed to 90 degree, and maintain the position. The test will be performed first with eyes open and then with the eyes closed. The time for which participant will be able to maintain balance will be recorded
Y- reach set
The participant will stand on one foot in the center of the Y with the most distal aspect of the toes just behind the starting line. While maintaining single-leg stance, the balance will be tested in the anterior, postero-medial and postero-lateral direction with reach foot. The reach distance in all the three directions will be noted.
Core Strength
The core strength will be measured with the Chattanooga Pressure Biofeedback Unit. The device will be placed under the lumbar spine in crook lying and inflated to a baseline of 40 mmHg. The participants will be instructed to perform drawing-in maneuver on the verbal instructions, maintain it for 10 sec. The change in pressure will be noted

Secondary Outcome Measures

Full Information

First Posted
March 17, 2020
Last Updated
April 12, 2021
Sponsor
Asir John Samuel
Collaborators
Maharishi Markandeshwar International School
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1. Study Identification

Unique Protocol Identification Number
NCT04315220
Brief Title
Corestability Training in Overweight Children
Official Title
Effectiveness of Core Stability Training in Improving Postural Stability and Foot Pressure Distribution in Overweight Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
February 13, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel
Collaborators
Maharishi Markandeshwar International School

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
A total of 52 overweight children aged between eight and sixteen years will be recruited by criterion based purposive sampling to participate in the two groups pretest post test randomized clinical study. Random allocation of the eligible subjects for treatment will be done by the block randomization method with matrix of thirteen rows and four columns (13x4). The subject will be allotted to the group randomly, based on the chit selected by the person other the primary researcher.Once the block is filled, the next row block will be opened. Thus equal distribution of overweight children in the each group will be ensured. Group A will be receiving actual core stability training (Level 1 - Mat exercises and Level 2 - Swiss Ball exercises) for 6 weeks with a frequency of three sessions per week.Group B will receive no training. Each session will last for 30 minutes of duration. The static and dynamic balance, foot pressure distribution and core strength will be assessed at the baseline and at the end of the treatment sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Child Obesity, Children, Only
Keywords
Noncommunicable disease, Balance, Posture, Childhood obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group pre-test post-test design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (Core stability training (CST))
Arm Type
Experimental
Arm Description
Core stability training (CST) consists of two levels: level 1- Mat exercises (includes abdominal muscle contraction, bridging,cat stretch,single leg circle and superman) and level 2- Swiss ball exercises (includes abdominal muscle contraction, bridging and squatting by using therapy ball). There will be three sets of 15 repetitions of each exercises. The first set will consist of 10 seconds hold period, follow by 12 seconds hold in second set and 15 seconds hold in third set respectively. The entire session will last for approximately 30 minutes.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Will not receive any kind of training.
Intervention Type
Other
Intervention Name(s)
Corestability training
Intervention Description
Level -1: Mat exercises Abdominal muscle contraction,bridging,cat stretch,single limb circle and superman.: Level- 2: Swiss Ball Exercises Abdominal contraction,bridging and squats.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
No Intervention
Primary Outcome Measure Information:
Title
Foot pressure distribution
Description
All overweight children will be asked to walk barefoot along a 5-.metre walkway using Harris mat pressure distribution platform which will be placed on a firm, level surface, in the centre of walkway. Children will be ensured to step on the Harris mat without pause, first with one foot and then repeat the same procedure with the other foot at constant speed. Foot markings then analyzed by using
Time Frame
change from baseline and six weeks
Title
Single limb stance
Description
The children will be instructed to stand on the dominant leg with non dominant leg flexed to 90 degree, and maintain the position. The test will be performed first with eyes open and then with the eyes closed. The time for which participant will be able to maintain balance will be recorded
Time Frame
change from baseline and six weeks
Title
Y- reach set
Description
The participant will stand on one foot in the center of the Y with the most distal aspect of the toes just behind the starting line. While maintaining single-leg stance, the balance will be tested in the anterior, postero-medial and postero-lateral direction with reach foot. The reach distance in all the three directions will be noted.
Time Frame
change from baseline and six weeks
Title
Core Strength
Description
The core strength will be measured with the Chattanooga Pressure Biofeedback Unit. The device will be placed under the lumbar spine in crook lying and inflated to a baseline of 40 mmHg. The participants will be instructed to perform drawing-in maneuver on the verbal instructions, maintain it for 10 sec. The change in pressure will be noted
Time Frame
change from baseline and six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children of age 8- 16 years old. Both Boys and Girls. Child with BMI-for-age percentile growth between 85th to less than 95th percentile. Exclusion Criteria: Uncooperative participants. Upper or lower limb fracture or injury in recent 6 months. Any musculoskeletal or neurological disorder affecting core strength and balance. Refuse to participate because not able to understand the researcher instructions. Unable to attend the whole sessions during the research period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanu Goyal, BPT, DOMTP
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asir J Samuel, MPT, PhD
Organizational Affiliation
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
Kanu Goyal
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Detail protocol will be published highlighting methods, statistical plan and Informed consent form
IPD Sharing Time Frame
Once (Before the start start)
IPD Sharing Access Criteria
Mendeley data Upload

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Corestability Training in Overweight Children

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