A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy (FOLIC)

• ClinicalTrials.gov Identifier: NCT05865418
• Recruitment Status: Recruiting
• First Posted: May 18, 2023
• Last Update Posted: August 18, 2023
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Harshvardhan Singh, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: May 1, 2023
• First Posted Date: May 18, 2023
• Last Update Posted Date: August 18, 2023
• Actual Study Start Date: August 10, 2023
• Estimated Primary Completion Date: May 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2023)

• Physical Activity [ Time Frame: Week 1 ]
  Step counts.
• Physical Activity [ Time Frame: Week 6 ]
  Step counts. An increase in step counts is expected.

Original Primary Outcome Measures (submitted: May 9, 2023)

• Physical Activity [ Time Frame: Week 1 and Week 2 ]
  Step counts.
• Physical Activity [ Time Frame: Week 8 ]
  Step counts. An increase in step counts is expected.
• Physical Activity [ Time Frame: Week 13 ]
  Step counts. An increase in step counts is expected.

Current Secondary Outcome Measures (submitted: August 15, 2023)

• Muscle Stiffness [ Time Frame: Week 1 ]
  Measure muscle and tendon stiffness. A decrease in stiffness is expected.
• Muscle Stiffness [ Time Frame: Week 6 ]
  Measure muscle and tendon stiffness. A decrease in stiffness is expected.
• Four square step test [ Time Frame: Week 1 ]
  Measure by time to complete test. A decrease in time completed is expected.
• Four square step test [ Time Frame: Week 6 ]
  Measure by time to complete test. A decrease in time completed is expected.
• Jumping test [ Time Frame: Week 1 ]
  Measure by jump height. An increase in jump height is expected.
• Jumping test [ Time Frame: Week 6 ]
  Measure by jump height. An increase in jump height is expected.

Original Secondary Outcome Measures (submitted: May 9, 2023)

• Muscle Stiffness [ Time Frame: Week 1 and Week 2 ]
  Measure muscle and tendon stiffness. A decrease in stiffness is expected.
• Muscle Stiffness [ Time Frame: Week 8 ]
  Measure muscle and tendon stiffness. A decrease in stiffness is expected.
• Muscle Stiffness [ Time Frame: Week 13 ]
  Measure muscle and tendon stiffness. A decrease in stiffness is expected.
• Four square step test [ Time Frame: Week 1 and Week 2 ]
  Measure by time to complete test. A decrease in time completed is expected.
• Four square step test [ Time Frame: Week 8 ]
  Measure by time to complete test. A decrease in time completed is expected.
• Four square step test [ Time Frame: Week 13 ]
  Measure by time to complete test. A decrease in time completed is expected.
• Jumping test [ Time Frame: Week 1 and Week 2 ]
  Measure by jump height. An increase in jump height is expected.
• Jumping test [ Time Frame: Week 8 ]
  Measure by jump height. An increase in jump height is expected.
• Jumping test [ Time Frame: Week 13 ]
  Measure by jump height. An increase in jump height is expected.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A New Training to Enhance Physical Activity in Adolescents With Cerebral Palsy
• Official Title: Feasibility and Response of a Novel Training on Dynamic Balance and Physical Activity in Adolescents With Cerebral Palsy
• Brief Summary: The purpose of this research study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy.

Detailed Description

Only 25% of independent ambulatory children with spastic cerebral palsy (CP) meet the recommendations of time spent in physical activity (PA). Lack of PA during growing years is one of the root causes of obesity, diabetes, and hypertension. Children with CP are known to have poorer dynamic balance and weaker muscle strength than typically developing children, explaining their slower walking speeds, lower PA, and higher tripping and falling than typically developing children. These deficits markedly amplify in adolescence. Consequently, there is a critical need to mitigate deficits in muscle strength and dynamic balance in ambulatory adolescents with CP to increase PA. High intensity circuit training (HICT) vs progressive resistance training (PRT) improved PA to a greater degree in children with CP. Despite the use of HICT, PA in children with CP is still below the recommended level. Our new exercise protocol combines the principles of HICT and PRT in one training program to improve PA in adolescences with CP. The aim of this study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy. In order to test the feasibility and response of the new exercise protocol, this study will have 3 groups of participants: 1) functionally loaded high intensity training exercise group, 2) a high intensity circuit training group, and 3) control group. For those two exercise groups, this study will include 4-week (weeks 2 - 5) exercise training program (including chair squat, side-step, split squat, heel raise, and jump). Children may/may not wear a weighted vest during exercising depend on their assigned group. For the non-exercise/control group, there is no intervention. Each group will have 2 sessions of baseline testing in week 1 and 1 session of post-testing in week 6. Coming for a single session of testing in week 9 is optional.

The following tests will be assessed before and after the exercise training program for all the groups: Lower limb strength and power via jump tests, balance via four-square step test, lateral step-up test, timed up and go tests, and walking tests. Their muscle and tendon stiffness will be assessed via a handheld device. Free living PA will be assessed via waist-worn accelerometers and questionnaires. Testing will be performed at 5 time points: tests at the first week (baseline 1 and baseline 2), sixth week (post training), ninth week (the follow up) of the study.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Adolescents with cerebral palsy will be randomly assigned to two unique exercise regimen and no exercise/standard-of-care group.

Masking: Single (Outcomes Assessor)
Masking Description:

Outcomes assessor will be blinded to the group assignment.

Primary Purpose: Other

Condition

• Cerebral Palsy
• Muscle Disorder
• Physical Disability
• Posture Disorders in Children

Intervention

• Other: Loaded high intensity training
  Participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 3rd of the intervention, the participants will perform the exercises with an adjustable weight vest with 5% of their body weight. In the middle intervention (post week 6 of the intervention which will be week 9 of the study), adolescents will be reevaluated for all the measures tested at the baseline. Weight vest will increase to 10% of their body weight for the last 4 weeks of the intervention.
• Other: High intensity circuit training (HICT)
  Participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions.

Study Arms

• Experimental: Loaded high intensity circuit training
  These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions. From the week 2-5 of the intervention, the participants will perform the exercises with an adjustable weight vest starting with 2.5% to finally reaching 10% of their body weight.
  Intervention: Other: Loaded high intensity training
• Active Comparator: High Intensity Training
  These participants will be familiarized to all the exercises. All exercises will have 3 sets, and the participants will be asked to perform as many repetitions as they can in 30s for each set. They will have 30 seconds to rest between sets (if they want more rest, we can let them more time but not exceed 60 seconds to limit the total amount of time for completing the exercise protocol) and 90 seconds to rest between exercises. Training sessions will occur twice per week with at least 24 hours between sessions.
  Intervention: Other: High intensity circuit training (HICT)
• No Intervention: Control
  They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 9, 2023): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2026
• Estimated Primary Completion Date: May 31, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• have a confirmed diagnosis of spastic cerebral palsy
• independent ambulatory
• able to follow verbal instructions
• willing to commit to participate for the full study

Exclusion Criteria:

• had previous orthopedic surgery or botulinum toxin A injection in the lower limb within past 6 months
• had a structured lower limb exercise training within the past 6 months
• plan to go for any structured outside-of the-study exercise training
• had any heart, lung, vision, hearing or bodily issues that can interfere with participation and completion of the study
• had any other diseases that interfere with physical activity.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 11 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: Harshvardhan Singh, PhD; 205-996-1413; hsingh@uab.edu

Contact: Phuong Quach, MPH; 205-774-8448; phuong@uab.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05865418
• Other Study ID Numbers: 300011118
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Harshvardhan Singh, University of Alabama at Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Harshvardhan Singh; University of Alabama at Birmingham

• PRS Account: University of Alabama at Birmingham
• Verification Date: August 2023