The Effects of Integrative Neuromuscular Training on Physical Function in Overweight Children

Obesity Clinical Trial

Official title:

The Effects of Integrative Neuromuscular Training on Physical Activity, Gait, Strength, and Body Composition in Overweight and Obese Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724303
• Other study ID #: StMarysUC8
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: June 28, 2024

Study information

• Verified date: February 2023
• Source: St. Mary's University, Twickenham
• Contact: Jourdana Durrell
• Phone: 07932743222
• Email: jourdana.durrell[@]stmarys.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Childhood obesity is an ongoing and increasing issue, resulting in changes in body mass which cause biomechanical alterations in the lower limbs. Exercise interventions have been effectiveness at causing positive changes to the lower limbs gait, strength and functioning but children often report lack of enjoyment from the sessions which inhibits long term changes. This intervention takes a neuromuscular exercise approach whilst considering the psychological needs of children to motivate them to participate in the intervention and physical activity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

Inclusion Criteria:

• children aged 8-11 years old

• overweight/obese children

Exclusion Criteria:

• children who have not given consent or had parental consent to participate

• children who fall outside of the selected age range

• children who have a physical or mental impairment that will affect their ability to participate in the procedures in the laboratory and intervention settings

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Overweight
• Pediatric Obesity

Intervention

Other:
• 8-week neuromuscular training program
Training program consisting of two neuromuscular training sessions per week

Locations

Country	Name	City	State
United Kingdom	Three Bridges	London Borough Of Ealing	London

Sponsors (1)

Lead Sponsor	Collaborator
St. Mary's University, Twickenham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body fat percentage	Bioelectrical impedance analysis of fat mass relative to body mass	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in fat free mass	Bioelectrical impedance analysis of fat free mass relative to body mass	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in body mass index (BMI)	BMI calculated with height measured barefoot on weight scales and height measured barefoot on Stadiometer and Z-score based on standard measures for age and gender. A reduction in BMI is a positive change.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in Hip 3d gait analysis	3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in Knee 3d gait analysis	3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in Ankle 3d gait analysis	3D joint angle, moment and power waveforms during stance phase. Moment and power dimensionless and normalised to body mass and leg length. Time normalised to 100% of stance and walking at a self-selected pace.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in Foot 3d gait analysis	Angle of the forefoot, midfoot, rearfoot and shank during the stance phase when walking at a self-selected pace.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in lower limb strength relative to body mass	Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to body mass	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in lower limb strength relative to fat free mass	Lower limb strength measured on Isokinetic Dynamometer in hip flexion/extension, hip abduction/adduction, knee flexion/extension, ankle plantarflexion/dorsiflexion. Maximal moments allometrically scaled to fat free mass	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in physical functioning: six-minute timed walk	Distance walked at a self-selected speed for six minutes	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in physical functioning: sit-to-stand test	The amount of repetitions of moving from a sitting position with knees at 90 degrees flexion to an upright standing position and return in one minute. Arms fixed across chest.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in physical functioning: timed up and go test	Time taken to rise from a seated position with knees at 90 degrees flexion and arms across chest, walk 3m and return back to seated position	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in physical functioning: single leg stand eyes open	Maximal time to maintain balance on one leg with hands on hip and free leg bent to 90degrees flexion	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in physical functioning: single leg stand eyed closed	Maximal time to maintain balance on one leg with eyes closed, hands on hip and free leg bent to 90degrees flexion	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in physical activity: percentage of time spent in sedentary activity levels	Accelerometer data captured and time spent in sedentary level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in physical activity: percentage of time spent in moderate to vigorous activity levels	Accelerometer data captured and time spent in moderate to vigorous level expressed as a percentage of time worn. Accelerometers worn on right side waist for one week.	From baseline to end of 8-week training program and to end of 8-week follow-up
Primary	Change in motivation towards physical activity	Behavioural Regulation in Exercise Questionnaire to measure motivation towards physical activity	From baseline to end of 8-week training program and to end of 8-week follow-up