The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
fitness training program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, bone density, bone strength
Eligibility Criteria
Inclusion Criteria:
- Aged 3-18 years
- Good cognition to comprehend the command
- Good cooperation during examination and fitness training
Exclusion Criteria:
- children with recognized chromosomal abnormalities
- Active medical conditions such as pneumonia or others
- Poor tolerance during assessment and fitness training
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
high level training group
low level training group
control
Arm Description
receive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes).
will receive low frequency fitness training program(Frequency: 1-2 times a week, Duration: 40 minutes).
No intervention, but maintain usual physical activities
Outcomes
Primary Outcome Measures
Bone mineral Density Measurements
BMD in the lumbar spine and hip are measured with DXA. Standard scanning procedures were used for the lumbar spine. BMD measurements (g/cm2) were converted to age- and gender-normalized standard deviation scores (z scores).
Secondary Outcome Measures
Children's Health Status
Children's Health Status Questionnaire
quality of life
Cerebral Palsy Quality of Life Questionnaire
Body composition
Body composition, lean body mass and body fat are measured
Muscle strength
Hand grasp assessment by the hand dynamometer Abdominal muscle strength by curling up
Flexibility
Forward bending distance during sitting position
Cardiopulmonary function
Measurement of times when performing stepping forward and backward for 1 minute. The changes of heart rate and blood pressure before and after stepping
Bone strength
Calcaneal bone strength BUA
Bone metabolism
Serum calcium, Phosphate,Serum intact parathyroid hormone (iPTH),Serum total alkaline phosphatase (ALP),Urine deoxypyridinoline(D-Pyr)
Motor function
BOTMP, GMFM
Muscle strength
isokinetic torque of knee flexor and extensor at different angular velocities
Full Information
NCT ID
NCT01378442
First Posted
June 21, 2011
Last Updated
June 10, 2013
Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01378442
Brief Title
The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
Official Title
The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In the first year, all subjects received clinical assessments include subjective assessment, basic data, nutritional status and fitness assessments. Laboratory assessments include body composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.
In the 2nd year, were randomized into three groups. The high level training group (20 children) will receive high frequency fitness training program(Frequency: three times one week, Duration: thirty minutes). The low level training group (20 children) will receive low frequency fitness training program(Frequency: two times one week, Duration: thirty minutes).The control group (20 children) will not receive fitness training program but maintain the usual life style.
In the 3rd year, all subjects received post-training clinical assessments include subjective assessment, basic data, nutritional status and fitness assessments. Laboratory assessments include body composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.
These data provided in this study could establish the bone quality and fitness data of children with diplegic CP, and provide us to plan treatment strategies in the management of bone and fitness problems in the future.
Detailed Description
Malnutrition and motor impairment are common in children with cerebral palsy. Poor nutrition and motor impairment may further contribute to fitness impairment, low bone mineralization density (BMD), low bone strength, and even fractures in children with CP. To management of bone problems is based on the understanding the pathophysiology of bone mineralization or bone strength in CP.
Multiple factors, including nutritional factors (eg. nutritional status, body composition) and non-nutritional factors (eg. fitness, immobility, use of anticonvulsants) that may potentially have an impact on bone density/strength in children with CP However, there were few studies to investigate the relationship of bone strength and fitness in children with cerebral palsy in Taiwan. We hypothesized that fitness training may potentially have an impact on bone density/strength in children with CP. The purpose of this study is to further find out the relationship of bone quality and fitness training in children with CP.
We will collect 60 children with diplegic CP. The inclusion criteria include good cognition to comprehend the command and cooperation during examination and fitness training. The exclusion criteria were following as chromosomal abnormalities, active medical conditions such as pneumonia or others, poor tolerance during assessment and fitness training.
In the first year, all subjects received clinical assessments include subjective assessment, basic data, nutritional status and fitness assessments. Laboratory assessments include body composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.
In the 2nd year, were randomized into three groups. The high level training group (20 children) will receive high frequency fitness training program(Frequency:three times one week, Duration: 40 minutes).The low level training group (20 children) will receive low frequency fitness training program(Frequency: 1-2 times one week, Duration: 40 minutes). The control group (20 children) will not receive fitness training program but maintain the usual life style.
In the 3rd year, all subjects received post-training clinical assessments include subjective assessment, basic data, nutritional status and fitness assessments. Laboratory assessments include body composition, bone density(lumbar spine and femur by dual energy X-ray absorptiometry ), bone strength (by calcaneal ultrasound) and bone metabolism.
These data provided in this study could establish the bone quality and fitness data of children with diplegic CP, and provide us to plan treatment strategies in the management of bone and fitness problems in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, bone density, bone strength
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high level training group
Arm Type
Experimental
Arm Description
receive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes).
Arm Title
low level training group
Arm Type
Experimental
Arm Description
will receive low frequency fitness training program(Frequency: 1-2 times a week, Duration: 40 minutes).
Arm Title
control
Arm Type
No Intervention
Arm Description
No intervention, but maintain usual physical activities
Intervention Type
Other
Intervention Name(s)
fitness training program
Intervention Description
Experimental: high level training group. The experimental group received training for 40 min per day 3 times a week for 12 weeks. The hVCT program consisted of a 5-min warm-up exercise, twenty repetitions of sitting-to-standing movements, cycling for 20 min, and a cool-down exercise for 5 min.
Experimental: low level training group. The experimental group received training for 40 min per day 1-2 times a week for 12 weeks. The program consisted of a 5-min warm-up exercise, twenty repetitions of sitting-to-standing movements, fitness training for 20 min, and a cool-down exercise for 5 min.
Control:The control group will not receive fitness training program but maintain the usual life style.
Primary Outcome Measure Information:
Title
Bone mineral Density Measurements
Description
BMD in the lumbar spine and hip are measured with DXA. Standard scanning procedures were used for the lumbar spine. BMD measurements (g/cm2) were converted to age- and gender-normalized standard deviation scores (z scores).
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Children's Health Status
Description
Children's Health Status Questionnaire
Time Frame
12 and 24 weeks
Title
quality of life
Description
Cerebral Palsy Quality of Life Questionnaire
Time Frame
12 and 24 weeks
Title
Body composition
Description
Body composition, lean body mass and body fat are measured
Time Frame
12 and 24 weeks
Title
Muscle strength
Description
Hand grasp assessment by the hand dynamometer Abdominal muscle strength by curling up
Time Frame
12 and 24 weeks
Title
Flexibility
Description
Forward bending distance during sitting position
Time Frame
12 and 24 weeks
Title
Cardiopulmonary function
Description
Measurement of times when performing stepping forward and backward for 1 minute. The changes of heart rate and blood pressure before and after stepping
Time Frame
12 and 24 weeks
Title
Bone strength
Description
Calcaneal bone strength BUA
Time Frame
12 and 24 weeks
Title
Bone metabolism
Description
Serum calcium, Phosphate,Serum intact parathyroid hormone (iPTH),Serum total alkaline phosphatase (ALP),Urine deoxypyridinoline(D-Pyr)
Time Frame
12 and 24 weeks
Title
Motor function
Description
BOTMP, GMFM
Time Frame
12 and 24 weeks
Title
Muscle strength
Description
isokinetic torque of knee flexor and extensor at different angular velocities
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 3-18 years
Good cognition to comprehend the command
Good cooperation during examination and fitness training
Exclusion Criteria:
children with recognized chromosomal abnormalities
Active medical conditions such as pneumonia or others
Poor tolerance during assessment and fitness training
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Ling Chen, PhD
Organizational Affiliation
Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
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The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
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