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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05865418
Collaborator
(none)
36
1
3
14.7
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Loaded high intensity training
  • Other: High intensity circuit training (HICT)
N/A

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 10-week 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.

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), second week (baseline 2), ninth week (the midpoint of the intervention), thirteenth week (the end of the intervention), and seventeenth week (the follow up) of the study, except accelerometers which will be done at the first, thirteenth, and seventeenth week; and questionnaires will be done at the second, thirteenth, and seventeenth week.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
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.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
Official Title:
Feasibility and Response of a Novel Training on Dynamic Balance and Physical Activity in Adolescents With Cerebral Palsy
Anticipated Study Start Date :
Jun 10, 2023
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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 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: 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.

Active Comparator: High intensity circuit training (HICT)

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.

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.

No Intervention: Control

They will continue their standard-of-care plan and will not involve in any new structured exercise program for 10 weeks.

Outcome Measures

Primary Outcome Measures

  1. Physical Activity [Week 1 and Week 2]

    Step counts.

  2. Physical Activity [Week 8]

    Step counts. An increase in step counts is expected.

  3. Physical Activity [Week 13]

    Step counts. An increase in step counts is expected.

Secondary Outcome Measures

  1. Muscle Stiffness [Week 1 and Week 2]

    Measure muscle and tendon stiffness. A decrease in stiffness is expected.

  2. Muscle Stiffness [Week 8]

    Measure muscle and tendon stiffness. A decrease in stiffness is expected.

  3. Muscle Stiffness [Week 13]

    Measure muscle and tendon stiffness. A decrease in stiffness is expected.

  4. Four square step test [Week 1 and Week 2]

    Measure by time to complete test. A decrease in time completed is expected.

  5. Four square step test [Week 8]

    Measure by time to complete test. A decrease in time completed is expected.

  6. Four square step test [Week 13]

    Measure by time to complete test. A decrease in time completed is expected.

  7. Jumping test [Week 1 and Week 2]

    Measure by jump height. An increase in jump height is expected.

  8. Jumping test [Week 8]

    Measure by jump height. An increase in jump height is expected.

  9. Jumping test [Week 13]

    Measure by jump height. An increase in jump height is expected.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Harshvardhan Singh, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05865418
Other Study ID Numbers:
  • 300011118
First Posted:
May 18, 2023
Last Update Posted:
May 18, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2023