The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebral Palsy |
Other: fitness training program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy |
- Bone mineral Density Measurements [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]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).
- Muscle strength [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]isokinetic torque of knee flexor and extensor at different angular velocities
- Bone strength [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Calcaneal bone strength BUA
- Children's Health Status [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Children's Health Status Questionnaire
- quality of life [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Cerebral Palsy Quality of Life Questionnaire
- Body composition [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Body composition, lean body mass and body fat are measured
- Muscle strength [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Hand grasp assessment by the hand dynamometer Abdominal muscle strength by curling up
- Flexibility [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Forward bending distance during sitting position
- Cardiopulmonary function [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Calcaneal bone strength BUA
- Bone metabolism [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]Serum calcium, Phosphate,Serum intact parathyroid hormone (iPTH),Serum total alkaline phosphatase (ALP),Urine deoxypyridinoline(D-Pyr)
- Motor function [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]BOTMP, GMFM
| Enrollment: | 60 |
| Study Start Date: | August 2007 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: high level training group
receive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes).
|
Other: fitness training program
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: No intervention, but keep usual physical activities Other Name: fitness training program
|
|
Experimental: low level training group
will receive low frequency fitness training program(Frequency: 1-2 times a week, Duration: 40 minutes).
|
Other: fitness training program
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: No intervention, but keep usual physical activities Other Name: fitness training program
|
|
No Intervention: control
No intervention, but maintain usual physical activities
|
Other: fitness training program
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: No intervention, but keep usual physical activities Other Name: fitness training program
|
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.
Eligibility| Ages Eligible for Study: | 3 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Taiwan | |
| Chang Gung Memorial Hospital | |
| Taoyuan, Taiwan, 333 | |
| Principal Investigator: | Chia-Ling Chen, PhD | Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01378442 History of Changes |
| Other Study ID Numbers: | 95-1164B |
| Study First Received: | June 21, 2011 |
| Last Updated: | January 30, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Chang Gung Memorial Hospital:
|
Cerebral palsy bone density bone strength |
Additional relevant MeSH terms:
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013