Childhood ObesityNCT04315220
Corestability Training in Overweight Children
A study testing Corestability training in people with Childhood Obesity and Child Obesity, run by Asir John Samuel at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Child Obesity, Children, Only
- What is being tested?
- Corestability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 13 Oct 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Core Stability Training in Improving Postural Stability and Foot Pressure Distribution in Overweight Children: A Randomized Controlled Trial
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
- Being tested
- Corestability training, No Intervention
- Keywords
- Noncommunicable disease, Balance, Posture, Childhood obesity, Overweight
- Medical subject headings
- Pediatric Obesity, Noncommunicable Diseases, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corestability trainingOther
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 InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Corestability training |
| Control group | Active comparator | Will not receive any kind of training. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: change from baseline and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start13 Oct 2020
- Primary completion13 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group pre-test post-test design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Collaborators
- Maharishi Markandeshwar International School
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Kanu Goyal, BPT, DOMTP, Principal investigator, Maharishi Markandeshwar Institute of Physiotherapy and RehabilitationAsir J Samuel, MPT, PhD, Study chair, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315220
- Sponsor's protocol ID
- MMDU/2020
- Other IDs
- U1111-1249-8305
- Status last verified
- Apr 2021
- First submitted
- 17 Mar 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Detail protocol will be published highlighting methods, statistical plan and Informed consent form
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Core Stability Training in Improving Postural Stability and Foot Pressure Distribution in Overweight Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04315220
- Acronym / sponsor ID
- MMDU/2020
- Conditions
- Childhood Obesity, Child Obesity, Children, Only
- Keywords
- Noncommunicable disease, Balance, Posture, Childhood obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Collaborators
- Maharishi Markandeshwar International School
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 13 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two group pre-test post-test design
| Arm | Type | Receives |
|---|---|---|
| Experimental group (Core stability training (CST)) | Experimental | Other: Corestability trainingCore 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. |
| Control group | Active comparator | Other: No InterventionWill not receive any kind of training. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corestability trainingLevel -1: Mat exercises Abdominal muscle contraction,bridging,cat stretch,single limb circle and superman.: Level- 2: Swiss Ball Exercises Abdominal contraction,bridging and squats. | Other | Experimental group (Core stability training (CST)) |
| No InterventionNo Intervention | Other | Control group |
Primary outcome
Foot pressure distribution
Time frame: change from baseline and six weeks
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
Time frame: change from baseline and six weeks
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
Time frame: change from baseline and six weeks
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
Time frame: change from baseline and six weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Yes. Detail protocol will be published highlighting methods, statistical plan and Informed consent form
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanu Goyal, BPT, DOMTP principal investigator
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Asir J Samuel, MPT, PhD study chair
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corestability training in people with Childhood Obesity and Child Obesity, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot pressure distribution (time frame: change from baseline and six weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2021.