Cerebral PalsyNCT01378442
The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
A study testing fitness training program in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- fitness training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 3-18 years
- Good cognition to comprehend the command
- Good cooperation during examination and fitness training
Who cannot join
- children with recognized chromosomal abnormalities
- Active medical conditions such as pneumonia or others
- Poor tolerance during assessment and fitness training
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- fitness training program
- Keywords
- Cerebral palsy, bone density, bone strength
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fitness training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| high level training group | Experimental | receive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes). Receives: 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). Receives: Other: fitness training program |
| control | No intervention | No intervention, but maintain usual physical activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 and 24 weeks
Secondary outcomes (10)
Children's Health Status
Children's Health Status Questionnaire
Measured: 12 and 24 weeks
quality of life
Cerebral Palsy Quality of Life Questionnaire
Measured: 12 and 24 weeks
Body composition
Body composition, lean body mass and body fat are measured
Measured: 12 and 24 weeks
Muscle strength
Hand grasp assessment by the hand dynamometer Abdominal muscle strength by curling up
Measured: 12 and 24 weeks
Flexibility
Forward bending distance during sitting position
Measured: 12 and 24 weeks
Cardiopulmonary function
Measurement of times when performing stepping forward and backward for 1 minute. The changes of heart rate and blood pressure before and after stepping
Measured: 12 and 24 weeks
Bone strength
Calcaneal bone strength BUA
Measured: 12 and 24 weeks
Bone metabolism
Serum calcium, Phosphate,Serum intact parathyroid hormone (iPTH),Serum total alkaline phosphatase (ALP),Urine deoxypyridinoline(D-Pyr)
Measured: 12 and 24 weeks
Motor function
BOTMP, GMFM
Measured: 12 and 24 weeks
Muscle strength
isokinetic torque of knee flexor and extensor at different angular velocities
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startAug 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chia-Ling Chen, PhD, Principal investigator, Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378442
- Sponsor's protocol ID
- 95-1164B
- Status last verified
- May 2011
- First submitted
- 21 Jun 2011
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Bone Strength and Fitness Training in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT01378442
- Acronym / sponsor ID
- 95-1164B
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, bone density, bone strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 22 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high level training group | Experimental | Other: fitness training programreceive high frequency fitness training program(Frequency: three times a week, Duration: 40 minutes). |
| low level training group | Experimental | Other: fitness training programwill receive low frequency fitness training program(Frequency: 1-2 times a week, Duration: 40 minutes). |
| control | No intervention | –No intervention, but maintain usual physical activities |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 3-18 years
- Good cognition to comprehend the command
- Good cooperation during examination and fitness training
Key exclusion criteria (3 listed)
- children with recognized chromosomal abnormalities
- Active medical conditions such as pneumonia or others
- Poor tolerance during assessment and fitness training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fitness training programExperimental: 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 | high level training group, low level training group |
Primary outcome
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).
10 secondary outcomes
Children's Health Status
Time frame: 12 and 24 weeks
quality of life
Time frame: 12 and 24 weeks
Body composition
Time frame: 12 and 24 weeks
Muscle strength
Time frame: 12 and 24 weeks
Flexibility
Time frame: 12 and 24 weeks
Cardiopulmonary function
Time frame: 12 and 24 weeks
Bone strength
Time frame: 12 and 24 weeks
Bone metabolism
Time frame: 12 and 24 weeks
Motor function
Time frame: 12 and 24 weeks
Muscle strength
Time frame: 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Ling Chen, PhD principal investigator
Department of Physical Medicine & Rehabilitation, Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fitness training program in people with Cerebral Palsy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral Density Measurements (time frame: 12 and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.