Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04315220
Other study ID # MMDU/2020
Secondary ID U1111-1249-8305
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2020
Est. completion date March 31, 2021

Study information

Verified date April 2021
Source Maharishi Markendeswar University (Deemed to be University)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 31, 2021
Est. primary completion date February 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 16 Years
Eligibility 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.

Study Design


Intervention

Other:
Corestability training
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.
No Intervention
No Intervention

Locations

Country Name City State
India Kanu Goyal Ambala Haryana

Sponsors (2)

Lead Sponsor Collaborator
Asir John Samuel Maharishi Markandeshwar International School

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05437406 - Family, Responsibility, Education, Support, and Health for Latino Caregivers (FRESH-LC) N/A
Completed NCT03297541 - Healthy Kids I-PAL N/A
Completed NCT05527938 - Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children N/A
Completed NCT05501392 - South Texas Early Prevention Studies PreK N/A
Completed NCT03334266 - Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months N/A
Active, not recruiting NCT03342092 - Early Adiposity Rebound Amongst 4-y.o. Children and Overweight Risk Amongst 11-y.o Children : Third Phase of a Cohort Study in Franche-Comté N/A
Completed NCT06239662 - Therapeutic Education Groups for Childhood Obesity N/A
Withdrawn NCT02767830 - Cleveland Kids Run N/A
Not yet recruiting NCT02889406 - Motivation Approach for Childhood Obesity Treatment N/A
Completed NCT03245164 - The Effects of Group Exercise and Basketball on Obese Children N/A
Completed NCT02484976 - Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging N/A
Completed NCT02559076 - The Eat Right Emirates Healthy Lifestyle Study N/A
Completed NCT01977105 - Healthy Growth Abbreviated Pilot Study N/A
Completed NCT02087774 - Brief Physical Activity Program to Increase Physical Fitness in Elementary School Children N/A
Completed NCT01789671 - Peer Counseling in Family-Based Treatment for Childhood Obesity N/A
Completed NCT01821313 - CASH- Children Active to Stay Healthy N/A
Completed NCT01849315 - Effects of Physical Activity on Disease Risk Factors N/A
Completed NCT02799433 - Evaluation of the Healthy Apple Program in San Francisco N/A
Completed NCT02637752 - Nutrition and Physical Activity Counselling N/A
Completed NCT01246349 - Motivational Interviewing for Weight Loss N/A