The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Interventions
- Other: fitness training program
- Registration Number
- NCT01378442
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Aged 3-18 years
- Good cognition to comprehend the command
- Good cooperation during examination and fitness training
- children with recognized chromosomal abnormalities
- Active medical conditions such as pneumonia or others
- Poor tolerance during assessment and fitness training
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description high level training group fitness training program receive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes). low level training group fitness training program will receive low frequency fitness training program(Frequency: 1-2 times a week, Duration: 40 minutes).
- Primary Outcome Measures
Name Time Method Bone mineral Density Measurements 12 and 24 weeks 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
Name Time Method Children's Health Status 12 and 24 weeks Children's Health Status Questionnaire
quality of life 12 and 24 weeks Cerebral Palsy Quality of Life Questionnaire
Body composition 12 and 24 weeks Body composition, lean body mass and body fat are measured
Muscle strength 12 and 24 weeks isokinetic torque of knee flexor and extensor at different angular velocities
Flexibility 12 and 24 weeks Forward bending distance during sitting position
Cardiopulmonary function 12 and 24 weeks 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 12 and 24 weeks Calcaneal bone strength BUA
Bone metabolism 12 and 24 weeks Serum calcium, Phosphate,Serum intact parathyroid hormone (iPTH),Serum total alkaline phosphatase (ALP),Urine deoxypyridinoline(D-Pyr)
Motor function 12 and 24 weeks BOTMP, GMFM
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan