- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01378442
The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high level training group
receive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes).
|
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. |
Experimental: low level training group
will receive low frequency fitness training program(Frequency: 1-2 times a week, Duration: 40 minutes).
|
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. |
No Intervention: control
No intervention, but maintain usual physical activities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone mineral Density Measurements
Time Frame: 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).
|
12 and 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's Health Status
Time Frame: 12 and 24 weeks
|
Children's Health Status Questionnaire
|
12 and 24 weeks
|
quality of life
Time Frame: 12 and 24 weeks
|
Cerebral Palsy Quality of Life Questionnaire
|
12 and 24 weeks
|
Body composition
Time Frame: 12 and 24 weeks
|
Body composition, lean body mass and body fat are measured
|
12 and 24 weeks
|
Muscle strength
Time Frame: 12 and 24 weeks
|
Hand grasp assessment by the hand dynamometer Abdominal muscle strength by curling up
|
12 and 24 weeks
|
Flexibility
Time Frame: 12 and 24 weeks
|
Forward bending distance during sitting position
|
12 and 24 weeks
|
Cardiopulmonary function
Time Frame: 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
|
12 and 24 weeks
|
Bone strength
Time Frame: 12 and 24 weeks
|
Calcaneal bone strength BUA
|
12 and 24 weeks
|
Bone metabolism
Time Frame: 12 and 24 weeks
|
Serum calcium, Phosphate,Serum intact parathyroid hormone (iPTH),Serum total alkaline phosphatase (ALP),Urine deoxypyridinoline(D-Pyr)
|
12 and 24 weeks
|
Motor function
Time Frame: 12 and 24 weeks
|
BOTMP, GMFM
|
12 and 24 weeks
|
Muscle strength
Time Frame: 12 and 24 weeks
|
isokinetic torque of knee flexor and extensor at different angular velocities
|
12 and 24 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chia-Ling Chen, PhD, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95-1164B
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