Exercise Training for Cerebral Palsy

(FOLIC Trial)

Overseen By Phuong Quach, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Orthopedic surgery, Botulinum toxin, Heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new exercise routine in increasing physical activity among teens with cerebral palsy. Participants will engage in either high-intensity circuit training (HICT) workouts or loaded high-intensity training (high-intensity workouts with weights), while a control group will maintain their usual routine. It suits individuals with cerebral palsy or spina bifida who can walk independently, follow instructions, and commit to the entire study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve physical activity strategies for teens with cerebral palsy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this exercise protocol is safe for adolescents with cerebral palsy?

Research has shown that high-intensity circuit training (HICT) is generally safe for teenagers with cerebral palsy. One study found that high-intensity exercises in a group setting are safe for teenagers with cerebral palsy who have good mobility, as participants did not encounter major safety issues.

For high-intensity training with weights, such as using adjustable weight vests, research also indicates safety. High-intensity interval training, similar to weighted exercises, has improved fitness in children with cerebral palsy without causing serious problems.

Both exercise methods are well-tolerated and can safely enhance strength and physical abilities, providing confidence in the safety of these exercise treatments for teenagers with cerebral palsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise training for cerebral palsy because it explores innovative approaches to improving physical function. Unlike traditional therapies that often focus on passive treatments or standard physical therapy, this trial investigates high-intensity circuit training methods. The high-intensity training encourages participants to push their limits with short bursts of maximum effort, which could lead to improvements in muscle strength and endurance. The loaded high-intensity circuit training further incorporates adjustable weight vests, adding a strength-building component that adapts to each participant's capacity. These methods aim to offer more dynamic and potentially more effective ways to enhance physical abilities in individuals with cerebral palsy.

What evidence suggests that this trial's exercise protocols could be effective for improving physical activity in adolescents with cerebral palsy?

Research has shown that high-intensity circuit training (HICT), one of the treatments in this trial, can help children with cerebral palsy become stronger. In one study, only the children participating in HICT showed increased strength, which also made it easier for them to join activities. Another study found that this type of training can improve movement in children with cerebral palsy.

Regarding loaded high-intensity circuit training, another treatment arm in this trial, studies have shown that high-intensity interval training can increase aerobic fitness by 10% in children with cerebral palsy, enhancing their quality of life. Exercises with weights have effectively improved movement skills and muscle strength in children with mild spastic diplegia, a form of cerebral palsy. ^{1 6 7 8 9}

Who Is on the Research Team?

HARSHVARDHAN SINGH, PT,PHD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adolescents with spastic cerebral palsy who can follow verbal instructions and walk on their own. They should be willing to fully participate in the study. Those with recent surgeries, injections in the lower limb, or other health issues that could affect exercise shouldn't apply.

Inclusion Criteria

I have been diagnosed with spastic cerebral palsy.

I can walk by myself without help.

Be able to follow verbal instructions

Exclusion Criteria

I have not had leg surgery or Botox injections in my leg in the last 6 months.

Plan to go for any structured outside-of-the-study exercise training

Had a structured lower limb exercise training within the past 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

2 sessions (in-person)

Baseline Testing

Baseline testing to assess lower limb strength, balance, and physical activity

1 week

2 sessions (in-person)

Exercise Training

Participants undergo a 4-week exercise training program combining high intensity circuit training and progressive resistance training

4 weeks

8 sessions (in-person)

Post-Testing

Post-testing to assess the effects of the exercise training program

1 week

1 session (in-person)

Follow-up

Participants are monitored for changes in physical activity and balance

3 weeks

1 optional session (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High intensity circuit training (HICT)
• Loaded high intensity training

Trial Overview

The study is testing a new exercise program designed to improve physical activity levels in teens with cerebral palsy. It involves loaded high intensity training and high intensity circuit training (HICT) to see if these methods are practical and effective.

How Is the Trial Designed?

Group I: Loaded high intensity circuit training Experimental Treatment 1 Intervention

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.

Group II: High Intensity Training Active Control 1 Intervention

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.

Group III: Control Active Control 1 Intervention

They will continue their standard-of-care plan and will not involve in any new structured exercise program for 6 weeks.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

High-intensity interval training (HIT) significantly improved aerobic exercise capacity in children with cerebral palsy, as evidenced by a 10% increase in peak oxygen uptake (VO2peak) after 24 training sessions.

While body composition did not change, parents reported an improvement in their children's quality of life, suggesting that HIT may enhance overall well-being, even if the children themselves did not perceive a difference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training to improve fitness in children with cerebral palsy. Lauglo, R., Vik, T., Lamvik, T., et al.[2020]

High Intensity Functional Training (HIFT) programs, such as CrossFit and HITT, offer practical benefits for military personnel, including shorter training times and lower injury potential compared to traditional endurance training, while still achieving significant fitness outcomes.

HIFT promotes various health benefits, including improved metabolic conditioning and muscular strength, and is scalable to all fitness levels, making it a recommended standard for military physical training despite the need for further research on its implementation and comparison with traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Benefits of High-Intensity Functional Training Fitness Programs for Military Personnel. Haddock, CK., Poston, WS., Heinrich, KM., et al.[2022]

A 6-month exercise program combining high intensity interval training (HIIT) and moderate intensity continuous training (MICT) showed similar improvements in cardiorespiratory fitness (CRF) and mental health markers (anxiety and depression) compared to a standard MICT program in stroke or TIA patients, with both exercise groups outperforming a control group.

Both exercise programs were well-accepted by participants, and the addition of HIIT was found to be safe, indicating that HIIT can be effectively integrated into rehabilitation for stroke patients without compromising safety or efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of high-intensity interval training to a moderate intensity continuous training cardiovascular rehabilitation program after ischemic cerebrovascular disease: A randomized controlled trial. Lapointe, T., Houle, J., Sia, YT., et al.[2023]

High-intensity circuit training (HICT) significantly reduced fat mass, diastolic blood pressure, total cholesterol, LDL cholesterol, triglycerides, and ApoB levels while increasing HDL cholesterol in healthy, overweight middle-aged individuals over 12 weeks.

Compared to traditional endurance training and low-intensity circuit training, HICT was more effective in improving cardiovascular disease risk factors, highlighting its potential as a superior exercise intervention for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity circuit training, low-intensity circuit training and endurance training on blood pressure and lipoproteins in middle-aged overweight men. Paoli, A., Pacelli, QF., Moro, T., et al.[2022]

A 6-week upper extremity high-intensity interval training (HIIT) program significantly improved oxygen uptake (V̇O2peak) by 4.1 ml·min·kg compared to continuous training (CT), indicating better cardiopulmonary capacity for participants.

HIIT also increased total exercise time during graded exercise tests by 1.4 minutes, suggesting it is a more time-efficient training method for enhancing aerobic performance compared to traditional continuous training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 6-Week Upper Extremity Low-Volume, High-Intensity Interval Training Program on Oxygen Uptake, Peak Power Output, and Total Exercise Time. Pinto, N., Salassi, JW., Donlin, A., et al.[2019]

A pilot study involving 12 adolescents with cerebral palsy showed that aquatic high intensity interval training is feasible, with a high adherence rate and no major adverse events reported during the 10-week program.

Participants found the training enjoyable and beneficial for social interaction, but further research is needed to determine its effectiveness compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aquatic high intensity interval training to improve aerobic capacity is feasible in adolescents with cerebral palsy: pilot randomised controlled trial. Depiazzi, J., Smith, N., Gibson, N., et al.[2022]

High-interval intensity training (HIT) significantly improves peak VO2 in patients with coronary artery disease (CAD) and heart failure (HF), with HF patients showing a greater increase in peak VO2 after training.

For optimal results in HF patients, recovery intervals should be active and maintained between 40% and 60% of peak VO2, and training frequency should be at least 3 days per week, while CAD patients benefit from a minimum of 2 days per week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity Interval Training Dosage for Heart Failure and Coronary Artery Disease Cardiac Rehabilitation. A Systematic Review and Meta-analysis. Ballesta García, I., Rubio Arias, JÁ., Ramos Campo, DJ., et al.[2019]

In a survey of 3049 CrossFit participants, 30.5% reported injuries over the past year, with the most common injuries affecting the shoulders (39%) and back (36%).

The overall injury rate was found to be relatively low at 0.27 per 1000 hours of training, suggesting that CrossFit is safer than traditional training methods, although beginners and those training less frequently are at higher risk for injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 4-Year Analysis of the Incidence of Injuries Among CrossFit-Trained Participants. Feito, Y., Burrows, EK., Tabb, LP.[2022]

High-intensity interval training (HIIT) is as effective, if not more so, than traditional moderate-intensity continuous training (MICT) for patients with cardiovascular disease, based on a systematic review of 23 studies involving 1117 participants.

The safety profile of HIIT in cardiac rehabilitation is promising, with only one major cardiovascular adverse event reported per 17,083 training sessions, indicating that HIIT can be safely implemented in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. Wewege, MA., Ahn, D., Yu, J., et al.[2021]

Adding high-load resistance exercises to a high-intensity functional training (HIFT) program significantly increased muscle mass by 3.3% and improved upper body strength in healthy adults, indicating enhanced physical fitness.

Both HIFT groups showed improvements in cardiorespiratory fitness and body composition after eight weeks, but the HIFT-P group demonstrated superior results in bench press strength, suggesting that incorporating heavy resistance can optimize training outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Addition of High-Load Resistance Exercises to a High-Intensity Functional Training Program Elicits Further Improvements in Body Composition and Strength: A Randomized Trial. Posnakidis, G., Aphamis, G., Giannaki, CD., et al.[2023]

High-intensity functional training (HIFT) sessions can lead to significant energy expenditure, averaging about 485 kcal per session, which translates to approximately 1400 kcal per week, making it a time-efficient exercise option.

The intensity of HIFT was found to be vigorous, with METs ranging from 5.5 to 11.6, and participants reaching about 80% of their maximum heart rate, indicating that HIFT can effectively meet exercise guidelines for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy Expenditure and Intensity of Group-Based High-Intensity Functional Training: A Brief Report. Willis, EA., Szabo-Reed, AN., Ptomey, LT., et al.[2020]

In a 12-week cardiac rehabilitation program involving 82 male patients, high-intensity interval training (HIIT) combined with continuous endurance training (CET) led to greater reductions in ventilatory equivalents for oxygen (EqO2) and carbon dioxide (EqCO2) compared to CET alone, particularly at higher exercise intensities.

Both HIIT+CET and CET were equally effective in managing blood lactate levels, indicating that while HIIT may enhance certain aspects of exercise performance, it does not lead to increased lactate accumulation during high-intensity efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-intensity interval training on trajectories of gas-exchange measures and blood lactate concentrations during cardiopulmonary exercise tests in cardiac rehabilitation-A randomized controlled trial. Heber, S., Gleiss, A., Kuzdas-Sallaberger, M., et al.[2023]

Citations

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The aim of this study was to compare strength and functional gains of home-based PRT and HICT and examine their influence on gait and participation in children ...

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Does Home-Based Progressive Resistance or High ...

Only the HICT group was able to improve strength. Furthermore, the HICT group scored better in the MPST, while PRT participants improved in the ...

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Does Home-Based Progressive Resistance or High ...

Results: Only the HICT group was able to improve strength. Furthermore, the HICT group scored better in the MPST, while PRT participants improved in the TST and ...

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Purpose: To investigate the effect of circuit training program on gross motor functions and functional capacity in children with hemiplegic CP.

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mdpi.com

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Effect of 4 Weeks of High-Intensity Interval Training (HIIT) ...

Additionally, improvements in anaerobic power output and athletic performance were observed in all three athletes over a short training period of four weeks.

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High-intensity functional exercise in a group-setting is safe in high functioning adolescents with cerebral palsy (CP) when following basic ...

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Body composition was unchanged. Parent-reported quality of life improved, whereas quality of life reported by the children did not improve.

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withpower.com

withpower.com/trial/phase-muscular-diseases-5-2023-dd03d

Exercise Training for Cerebral Palsy (FOLIC Trial)

High-intensity interval training (HIT) significantly improved aerobic exercise capacity in children with cerebral palsy, as evidenced by a 10% increase in peak ...