The Effect of Exercise Training on Musculoskeletal Health in Individuals With Cerebral Palsy

NCT05070117 | Completed

• 1 other identifier: F17081
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (7)

• 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.

  1 minute

• 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.

  8 minutes

• 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.

  15 minutes

• 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.

  20 minutes

• 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.

  8 minutes

• 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.

  1 minute

• 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.

  2 minutes

Study Arms (1)

Resistance/strength training

EXPERIMENTAL

Behavioral: Exercise training

Interventions

Exercise training BEHAVIORAL

Study participants perform resistance/strength exercises 2-3 times per week for one hour, for one year.

Resistance/strength training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• If subjects have a history or symptoms of cardiovascular, renal, hepatic, or respiratory diseases, they will be excluded in the study.

Sponsors & Collaborators

• San Jose State University: lead

Study Sites (1)

San Jose State University

San Jose, California, 95192, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mohamed Abousalem, Ph.D

  SJSU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: October 7, 2021
• Study Start: January 19, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available 2 years after our manuscripts are published and for additional 3 years.
• 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

Locations

US (1)