The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- those who can follow simple commands and walk independently with or without the use of an assistance apparatus (within Classification level I-III, based on Gross Motor Functioning Classification System, GMFCS) and have cerebral palsy will be included in the study. The rationale for such inclusion criteria (level I-III) is to make sure they can perform some leg exercise and tests.
Exclusion Criteria:
- If subjects have a history or symptoms of cardiovascular, renal, hepatic, or respiratory diseases, they will be excluded in the study.
Sites / Locations
- San Jose State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Resistance/strength training
Arm Description
Outcomes
Primary Outcome Measures
Height measurement
Height (cm) will be measured using a standard beam scale with height rod. This anthropometric measurement is used to assess general body size. Body mass index is calculated and reported.
Body composition
Whole body Dual energy X-ray absorptiometry (DXA) will be measured to assess overall body composition for the mass of the bone, muscle, and fat in the whole body. For those who do not complete DXA due to severe spasticity, a bioelectrical impedance technique (BIA) using 4 electrode unit Biodynamics Model 310 Body Composition Analyzer will be used to quantify fat mass, fat free mass, and water content. BIA does not use x-ray; thus, participants will not be exposed additional radiation.
Muscular strength
Participants will perform leg press, leg curl, and leg extension at submaximal level to predict 1-Repetition Masimum using Brzycki equations. In addition, participants will perform knee extension and flexion testing using Humac Norm Isokinetic Dynamometer to measure isometric and isokinetic muscular strength in hamstrings and quadriceps.
Balance and related fall risks
Berg Balance Scale and Biodex Balance System will be used to assess balance and related fall risks. The Berg Balance Scale is a valid and reliable tool to assess populations with gait and balance issues. By completing 14 assessments with varying multiple tasks, participants will receive a point per task to have a final score which indicate the balance and risk of fall. Biodex Balance System assesses neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on both static and unstable surface. These tests will provide a quantified value for fall risk screening and conditioning status.
Bone mineral density
Bone mineral content and density using regional Dual energy X-ray absorptiometry (DXA) will be measured at regions of lumbar spine (L2-4), proximal femur at the hip joint, and forearm. T- and Z-scores of each region will be calculated to detect bone mineral density as well as the changes due to the intervention.
Weight measurement
Weight (kg) will be measured using a standard beam scale with height rod. This anthropometric measurement is used to assess general body size. Body mass index is calculated and reported.
Waist and hip circumferences
Waist and hip circumference (cm) will be measured using a measuring tape. These anthropometric measurements are used to assess general body size.
Secondary Outcome Measures
Full Information
NCT ID
NCT05070117
First Posted
August 23, 2021
Last Updated
January 31, 2022
Sponsor
San Jose State University
1. Study Identification
Unique Protocol Identification Number
NCT05070117
Brief Title
The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
Official Title
The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Jose State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cerebral palsy (CP) is a neurodevelopmental disorder and is the most common childhood disability. CP is characterized by abnormal development, impaired motor function, and muscular and skeletal abnormalities. Due to their diminished musculoskeletal function, individuals with CP suffer a high rate of moderate to severe bone fractures, which can lead to further immobility. Optimizing muscle and bone health with exercise may be important in minimizing fractures from limited mobility, and fundamental for maximizing health-related quality of life. The main purpose of this research is to investigate the effect of exercise training on musculoskeletal system in individuals with CP, with the goal of reducing the incidence of falls and fractures. To accomplish these aims, musculoskeletal health will be assessed using various physiological techniques (e.g., Dual energy X-ray Absorptiometry, Humac Norm Isokinematic System, Biodex Balance System) before, during, and after one year of exercise training in individuals with CP. In addition, various functional mobility tests to quantify fitness levels will be performed. Findings may lead to the development of novel therapeutic interventions targeted at improving musculoskeletal health in individuals with CP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistance/strength training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Study participants perform resistance/strength exercises 2-3 times per week for one hour, for one year.
Primary Outcome Measure Information:
Title
Height measurement
Description
Height (cm) will be measured using a standard beam scale with height rod. This anthropometric measurement is used to assess general body size. Body mass index is calculated and reported.
Time Frame
1 minute
Title
Body composition
Description
Whole body Dual energy X-ray absorptiometry (DXA) will be measured to assess overall body composition for the mass of the bone, muscle, and fat in the whole body. For those who do not complete DXA due to severe spasticity, a bioelectrical impedance technique (BIA) using 4 electrode unit Biodynamics Model 310 Body Composition Analyzer will be used to quantify fat mass, fat free mass, and water content. BIA does not use x-ray; thus, participants will not be exposed additional radiation.
Time Frame
8 minutes
Title
Muscular strength
Description
Participants will perform leg press, leg curl, and leg extension at submaximal level to predict 1-Repetition Masimum using Brzycki equations. In addition, participants will perform knee extension and flexion testing using Humac Norm Isokinetic Dynamometer to measure isometric and isokinetic muscular strength in hamstrings and quadriceps.
Time Frame
15 minutes
Title
Balance and related fall risks
Description
Berg Balance Scale and Biodex Balance System will be used to assess balance and related fall risks. The Berg Balance Scale is a valid and reliable tool to assess populations with gait and balance issues. By completing 14 assessments with varying multiple tasks, participants will receive a point per task to have a final score which indicate the balance and risk of fall. Biodex Balance System assesses neuromuscular control by quantifying the ability to maintain dynamic bilateral and unilateral postural stability on both static and unstable surface. These tests will provide a quantified value for fall risk screening and conditioning status.
Time Frame
20 minutes
Title
Bone mineral density
Description
Bone mineral content and density using regional Dual energy X-ray absorptiometry (DXA) will be measured at regions of lumbar spine (L2-4), proximal femur at the hip joint, and forearm. T- and Z-scores of each region will be calculated to detect bone mineral density as well as the changes due to the intervention.
Time Frame
8 minutes
Title
Weight measurement
Description
Weight (kg) will be measured using a standard beam scale with height rod. This anthropometric measurement is used to assess general body size. Body mass index is calculated and reported.
Time Frame
1 minute
Title
Waist and hip circumferences
Description
Waist and hip circumference (cm) will be measured using a measuring tape. These anthropometric measurements are used to assess general body size.
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
those who can follow simple commands and walk independently with or without the use of an assistance apparatus (within Classification level I-III, based on Gross Motor Functioning Classification System, GMFCS) and have cerebral palsy will be included in the study. The rationale for such inclusion criteria (level I-III) is to make sure they can perform some leg exercise and tests.
Exclusion Criteria:
If subjects have a history or symptoms of cardiovascular, renal, hepatic, or respiratory diseases, they will be excluded in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abousalem, Ph.D
Organizational Affiliation
SJSU
Official's Role
Study Director
Facility Information:
Facility Name
San Jose State University
City
San Jose
State/Province
California
ZIP/Postal Code
95192
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We understand the importance of data sharing and archiving for our scholarly community and to society at large. We are willing to share our data as for a significant contribution to the scientific community. Upon request, we will submit an share our data with public as recommended. However, as a part of informed consent process and to meet the confidentiality, we will not share any personal information of our research participants
IPD Sharing Time Frame
The data will become available 2 years after our manuscripts are published and for additional 3 years.
IPD Sharing Access Criteria
Access to Individual Patient Data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan as well as the execution of a Data Sharing Agreement. For more information or to submit a request, please contact areum.jensen@sjsu.edu
Learn more about this trial
The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy
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