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

NCT01378442 | Completed DMC

• 1 other identifier: 95-1164B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; bone density; bone strength

Outcome Measures

Primary Outcomes (1)

• 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).

  12 and 24 weeks

Secondary Outcomes (10)

• Children's Health Status

  12 and 24 weeks

• quality of life

  12 and 24 weeks

• Body composition

  12 and 24 weeks

• Muscle strength

  12 and 24 weeks

• Flexibility

  12 and 24 weeks

Study Arms (3)

high level training group

EXPERIMENTAL

receive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes).

Other: fitness training program

low level training group

EXPERIMENTAL

will receive low frequency fitness training program(Frequency: 1-2 times a week, Duration: 40 minutes).

Other: fitness training program

control

NO INTERVENTION

No intervention, but maintain usual physical activities

Interventions

fitness training program OTHER

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.

high level training group; low level training group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 3-18 years
• Good cognition to comprehend the command
• Good cooperation during examination and fitness training

You may not qualify if:

• children with recognized chromosomal abnormalities
• Active medical conditions such as pneumonia or others
• Poor tolerance during assessment and fitness training

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chia-Ling Chen, PhD

  Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 22, 2011
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 12, 2013

Record last verified: 2011-05

Locations

TW (1)