Corestability Training in Overweight Children

NCT04315220 | Completed DMC

• 2 other identifiers: MMDU/2020U1111-1249-8305
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity; Child Obesity; Children, Only

Keywords

Noncommunicable disease; Balance; Posture; Childhood obesity; Overweight

Outcome Measures

Primary Outcomes (4)

• 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

  change from baseline and six weeks

• 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

  change from baseline and six weeks

• 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.

  change from baseline and six weeks

• 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

  change from baseline and six weeks

Study Arms (2)

Experimental group (Core stability training (CST))

EXPERIMENTAL

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.

Other: Corestability training

Control group

ACTIVE COMPARATOR

Will not receive any kind of training.

Other: No Intervention

Interventions

Corestability training OTHER

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.

Experimental group (Core stability training (CST))

No Intervention OTHER

No Intervention

Control group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asir John Samuel: lead
• Maharishi Markandeshwar International School: collaborator

Study Sites (1)

Kanu Goyal

Ambāla, Haryana, 133207, India

Location

MeSH Terms

Conditions

Pediatric Obesity; Noncommunicable Diseases; Overweight

Condition Hierarchy (Ancestors)

Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Kanu Goyal, BPT, DOMTP

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Asir J Samuel, MPT, PhD

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two group pre-test post-test design

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: October 13, 2020
• Primary Completion: February 13, 2021
• Study Completion: March 31, 2021
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once (Before the start start)
• Access Criteria: Mendeley data Upload

Locations

IN (1)