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The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01378442
First received: June 21, 2011
Last updated: June 10, 2013
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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

  • Muscle strength [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    isokinetic torque of knee flexor and extensor at different angular velocities


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:The control group will not receive fitness training program but maintain the usual life style.

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:The control group will not receive fitness training program but maintain the usual life style.

Other Name: fitness training program
No Intervention: control
No intervention, but maintain usual physical activities

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378442

Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
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: June 10, 2013
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 November 20, 2014