Functional Exercise Training in Cerebral Palsy: Follow Up (FITCP)

March 26, 2024 updated by: Alice Minghetti, University of Basel

Functional Exercise Training With Adolescents and Young Adults With Cerebral Palsy: Follow Up Study

The goal of this cross-sectional study is to compare able-bodied peers to adolescents and young adults with cerebral palsy (CP) who have been regularly performing high-intensity functional training for almost two years.

The main research question is: is structured, long-term exercise training able to compensate strength and cardiovascular deficits in adolescents with CP compared to able-bodied peers?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pilot study investigating the effects of a functional exercise training in adolescents and young adults with cerebral palsy (CP) showed increases in strength, power, daily function as well as cardiovascular health. In order to establish the origin of the improvements and its broader effects, we wish to conduct follow-up measurements to the pilot study. These follow-up measurements would establish whether the positive changes in physical performance are due to neural or muscular changes (or both), and shed more light on how therapy should be performed and prescribed in adolescents with CP. Additionally, we wish to measure their aerobic capacity as well as examine their microvascular health. For this cross-sectional analysis, the participants of the CP-FIT Pilot Study who continued to train on a regular basis will be compared to age-matched peers in order to establish whether their strength and fitness deficits compared to peers can be compensated through structured and progressive functional exercise training.

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4052
        • Department of Sport, Exercise and Health, University of Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The group adolescents with CP consists of individuals from the CP-FIT pilot study who have both continued or discontinued their training after study completion. Healthy peers are age- and sex-matched able-bodied peers.

Description

Inclusion Criteria:

CP Individuals:

  • Diagnosis of CP.
  • Between 14 and 26 years of age.
  • Gross Motor Functional Classification System (GMFCS): I-II.
  • Cognitive abilities must include: Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend testing and; ability to understand and follow instructions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.

Healthy peers:

- Between 14 and 26 years of age.

Exclusion Criteria:

CP Individuals:

  • Any surgery or botulinum toxin treatment within 6 months prior to the measurements or scheduled during study period. Other medications can be continued as prescribed by the participants' physician.
  • Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in physical exercise.
  • Uncontrolled seizures or epilepsy.
  • Inability to conform to the above mentioned cognitive and physical abilities.

Healthy peers:

  • Diagnosis of congenital heart defects, pulmonary diseases or any neuromuscular disorders or diseases.
  • Diagnosis of any acute diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trained CP
Adolescents and young adults with CP who have continued their regular training after completing the pilot study.
Other: Physical performance and cardiovascular health measures
  • Retinal vessel analysis
  • Muscle ultrasound
  • Knee extension
  • Voluntary activation
  • spiroergometry
Untrained CP
Adolescents and young adults with CP who have not continued their regular training after completing the pilot study.
Other: Physical performance and cardiovascular health measures
  • Retinal vessel analysis
  • Muscle ultrasound
  • Knee extension
  • Voluntary activation
  • spiroergometry
Trained Peers
Healthy peers who perform high-intensity strength training on a regular basis.
Other: Physical performance and cardiovascular health measures
  • Retinal vessel analysis
  • Muscle ultrasound
  • Knee extension
  • Voluntary activation
  • spiroergometry
Untrained Peers
Healthy peers who do not perform high-intensity strength training on a regular basis.
Other: Physical performance and cardiovascular health measures
  • Retinal vessel analysis
  • Muscle ultrasound
  • Knee extension
  • Voluntary activation
  • spiroergometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum knee extension force
Time Frame: 20 minutes
Maximum force of knee extension in relation to body weight
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microvascular health
Time Frame: 5 minutes
Static retinal vessel analysis
5 minutes
Voluntary activation
Time Frame: 15 minutes
Maximum force able to voluntarily activate
15 minutes
Spiroergometry
Time Frame: 20 minutes
Cardiopulmonary test on bicycle ergometer
20 minutes
Muscle architecture
Time Frame: 10 minutes
Ultrasound of defined muscle groups
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

March 5, 2024

Study Completion (Actual)

March 26, 2024

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 4, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FITCP: Follow Up

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be made public. Group data will be analysed for publication after study completion.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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