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Completed

NCT Number: NCT05859360

Functional Exercise Training in Cerebral Palsy: Follow Up

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?

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Key information

Age range

14 year–27 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Sport, Exercise and Health, University of Basel

Basel, Canton of Basel-City, 4052, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical performance and cardiovascular health measures

Other
  • Retinal vessel analysis
  • Muscle ultrasound
  • Knee extension
  • Voluntary activation
  • spiroergometry

Primary outcomes

  1. Maximum knee extension force

    Time frame: 20 minutes

    Maximum force of knee extension in relation to body weight

Secondary outcomes

  1. Microvascular health

    Time frame: 5 minutes

    Static retinal vessel analysis

  2. Voluntary activation

    Time frame: 15 minutes

    Maximum force able to voluntarily activate

  3. Spiroergometry

    Time frame: 20 minutes

    Cardiopulmonary test on bicycle ergometer

  4. Muscle architecture

    Time frame: 10 minutes

    Ultrasound of defined muscle groups

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Registry information

Official study title

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

Acronym: FITCP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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