Clinical trial NCT05665621: The Effects of Strength and Balance Training on Physical Function in Overweight Children
Official title: The Effect of Strength and Combined Balance Training Intervention Programme on Physical Function, Physical Activity, and Musculoskeletal Health in Children With Overweight and Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: St. Mary's University, Twickenham
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the United Kingdom. The main question\[s\] it aims to answer are:

* Is the school-based exercise programme effective in improving lower limb muscular strength and balance control?
* How do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? Participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3D gait, plantar pressure, physical function and physical activity. The intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks.

Researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.


Eligibility criteria: Inclusion Criteria:

* Overweight or obese

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Body Mass Index Z-Score
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in body fat percentage
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in fat free mass (kg)
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in lower limb 3D gait.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in 3D foot in gait.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in lower limb muscular strength relative to body mass.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in lower limb muscular strength relative to fat free mass.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in six minute walk distance.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in sit to stand repetitions
timeFrame: Baseline to end of 8-week intervention and to end of 8-week follow up period.
measure: Change in timed up and go time
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in single leg stance time
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in single leg stance time with eye closed
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in percentage of time spent in sedentary activity.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in percentage of time spent in moderate to vigorous activity.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in total vector magnitude counts
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in quality of life score.
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in pain reported now
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in worst pain
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in physical activity enjoyment scale
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
measure: Change in basic psychological needs in exercise scale score
timeFrame: Baseline to end of the 8-week intervention and to end of 8-week follow-up period.
Secondary outcomes:
Other outcomes:
Locations:
city: Hounslow
country: United Kingdom
facility: Orchard Primary school
state: Greater London
city: Isleworth
country: United Kingdom
facility: Isleworth Town Primary School
state: Greater London
city: Hounslow
country: United Kingdom
facility: Beavers Primary School
state: London
Study officials:
affiliation: St. Mary's University, Twickenham
name: Ryan Mahaffey, PhD
role: PRINCIPAL_INVESTIGATOR
References: