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

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: Cerebral Palsy
• Intervention / Treatment: Other: Physical performance and cardiovascular health measures

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

4

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	Maximum force of knee extension in relation to body weight	20 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Basel

Study record dates

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: cerebral palsy; strength; cardiovascular health; functional training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• 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