NCT04491019

Brief Summary

Obesity is one of the most important health problems of developed and developing countries. Especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. In obese individuals, the effects of postural control and balance have been reported to cause musculoskeletal problems, and motor control skills have been found to decrease. The aim of this study is to compare the effects of balance exercises and strengthening exercises on balance, posture and lower extremity functions in obese adolescents.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 27, 2020

Last Update Submit

July 27, 2020

Conditions

Obesity, Adolescent

Outcome Measures

Primary Outcomes (1)

  • The six-minute walking test

    The six-minute walking test is an example of timed distance testing, widely used in clinical research and rehabilitation studies. According to the guidelines published by the American Thoracic Society, 6MWT is an easy-to-use, better tolerated test that reflects daily activities better than other walking tests. It can be applied in a short time. Requires little equipment. The six-minute walk test, used as a field test, is a simple and inexpensive test compatible with daily activities, which does not require exercise equipment. Before starting the test, the patient should rest for at least 10 minutes by sitting in the chair near the starting point. The walking area must be at least 30 m long. A shorter corridor causes more time to be spent for more frequent turns and changes of direction. With the help of stopwatch, it is kept for 6 minutes and the number of laps during the period is calculated and recorded. The functional capacity of the cases will be evaluated with 6MWT.

    Change from baseline to 8 weeks, follow up at two months

Secondary Outcomes (8)

  • Sit Up Stand Test

    Change from baseline to 8 weeks, follow up at two months

  • Evaluation of Muscle Force

    Change from baseline to 8 weeks, follow up at two months

  • 10 Step Down Time Test

    Change from baseline to 8 weeks, follow up at two months

  • Functional Forward Reach Test

    Change from baseline to 8 weeks, follow up at two months

  • Flamingo Balance Test

    Change from baseline to 8 weeks, follow up at two months

  • +3 more secondary outcomes

Study Arms (2)

Balance exercise group

EXPERIMENTAL

Balance exercises will be carried out with a physiotherapist.

Other: Balance exercise group

Strengthening exercise group

EXPERIMENTAL

Strengthening exercises will be performed with a physiotherapist.

Other: Balance exercise group

Interventions

Balance exercise groupOTHER

Balance exercises will be carried out with a physiotherapist

Balance exercise groupStrengthening exercise group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Individuals aged 12-18 Body Mass Index to be 95 and above according to percentile values No exercise program in the past 6 months

You may not qualify if:

  • Having a medical condition that prevents exercise Having a disease of neuromuscular origin Presence of psychiatric or neurological diseases affecting cooperative and cognitive functions Equilibrium effect due to another disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34740, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

July 27, 2020

First Posted

July 29, 2020

Study Start

February 27, 2020

Primary Completion

July 30, 2020

Study Completion

September 30, 2021

Last Updated

July 29, 2020

Record last verified: 2020-07

Locations

TU(1)