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

31 januari 2022 uppdaterad av: Areum Jensen, San Jose State University
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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

29

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • San Jose, California, Förenta staterna, 95192
        • San Jose State University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Resistance/strength training
Beteende: Exercise training
Study participants perform resistance/strength exercises 2-3 times per week for one hour, for one year.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Height measurement
Tidsram: 1 minute
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
Tidsram: 8 minutes
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
Tidsram: 15 minutes
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
Tidsram: 20 minutes
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
Tidsram: 8 minutes
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
Tidsram: 1 minute
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
Tidsram: 2 minutes
Waist and hip circumference (cm) will be measured using a measuring tape. These anthropometric measurements are used to assess general body size.
2 minutes

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

San Jose State University

Utredare

  • Studierektor: Mohamed Abousalem, Ph.D, SJSU

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 januari 2018

Primärt slutförande (Faktisk)

1 december 2021

Avslutad studie (Faktisk)

1 december 2021

Studieregistreringsdatum

Först inskickad

23 augusti 2021

Först inskickad som uppfyllde QC-kriterierna

27 september 2021

Första postat (Faktisk)

7 oktober 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 februari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 januari 2022

Senast verifierad

1 januari 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • F17081

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-planbeskrivning

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

Tidsram för IPD-delning

The data will become available 2 years after our manuscripts are published and for additional 3 years.

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • Studieprotokoll
  • Statistisk analysplan (SAP)
  • Informerat samtycke (ICF)
  • Klinisk studierapport (CSR)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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