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

5 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment High intensity circuit training (HICT) and related high-intensity training methods for cerebral palsy?

Research shows that high-intensity interval training (HIIT) can improve aerobic exercise capacity and quality of life in children with cerebral palsy. Additionally, similar high-intensity training methods have been effective in improving fitness and endurance in other populations, such as military personnel and stroke patients, suggesting potential benefits for those with cerebral palsy. ^{1 2 3 4 5}

Is high-intensity exercise training generally safe for humans?

High-intensity interval training (HIIT) has shown a relatively low rate of major adverse cardiovascular events in patients with heart conditions when done in a controlled setting. However, some reports have linked high-intensity functional training (HIFT), like CrossFit, to severe injuries, though empirical safety data is limited. ^{6 7 8 9 10}

How does the treatment High intensity circuit training (HICT) for cerebral palsy differ from other treatments?

High intensity circuit training (HICT) for cerebral palsy is unique because it combines high-intensity exercises with resistance training, which can improve cardiorespiratory fitness and strength more effectively than traditional moderate-intensity exercises. This approach is similar to high-intensity interval training (HIIT) used in other conditions, offering a time-efficient way to enhance physical fitness. ^{2 3 4 11 12}

What is the purpose of this trial?

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.

Research Team

HARSHVARDHAN SINGH, PT,PHD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

Be able to follow verbal instructions

Be willing to commit to participate for the full study

I have been diagnosed with spastic cerebral palsy.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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-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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

High-intensity interval training to improve fitness in children with cerebral palsy. [2020]

2. United States 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The Benefits of High-Intensity Functional Training Fitness Programs for Military Personnel. [2022]

4. Switzerland 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. [2023]

5. England 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. [2022]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

High-Intensity Interval Training for Patients With Cardiovascular Disease-Is It Safe? A Systematic Review. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A 4-Year Analysis of the Incidence of Injuries Among CrossFit-Trained Participants. [2022]

9. Switzerland 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Energy Expenditure and Intensity of Group-Based High-Intensity Functional Training: A Brief Report. [2020]

11. Spain 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. [2019]

12. Denmark 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. [2023]