Exercise for Communication Disorders

Overseen By Danielle Rice

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Marquette University

Disqualifiers: Autism, Vision impairments, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 21

Duration: 6 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial study has two goals. The first goal is to establish fitness levels, participation in physical activities, and fine/gross motor abilities for children with development language disorder (DLD). DLD occurs in 1/13 children and children with DLD often have poorer fine/gross motor skills than those with typical development. The second goal is to determine whether physical exercise helps children with DLD and typical development to learn better and improve fitness and fine/gross motor abilities more than participating in restful play activities. All children (DLD and typically developing) will undergo communication, fine/gross motor and fitness testing. Children will be randomly assigned to participate in an exercise program (n =20) or to a restful play program (n = 20). Both programs will take place 3x/week for 6 weeks and children will only participate in one of the two programs. Children in the exercise program will do activities to train cardiovascular fitness, agility, balance, strength, and endurance while children in the restful play condition will do things like play with legos and color. Researchers will compare changes in learning tasks and fitness levels for children (DLD and typically developing) who participated in the exercise program vs. restful play program.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Exercise Training, Cardiac Rehabilitation, Physical Therapy, Exercise Intervention for communication disorders?

Research shows that exercise therapy, including cardiac rehabilitation and physical therapy, is effective for improving physical and psychological outcomes in patients with heart and lung diseases, as well as various chronic conditions. While not directly related to communication disorders, these findings suggest potential benefits of exercise interventions in improving overall health and function, which could indirectly support communication abilities. ^{1 2 3 4 5}

Is exercise generally safe for people with various health conditions?

Exercise interventions, including those for pediatric cancer patients and cardiac rehabilitation, are generally safe with rare serious adverse events. Most common minor issues include muscle soreness and circulatory problems, but these are not typically linked directly to the exercise itself. ^{6 7 8 9 10}

How is the treatment 'Exercise Training' unique for communication disorders?

Exercise Training is unique for communication disorders because it focuses on improving physical function and overall health through activities like balance, strengthening, and endurance exercises, which are not typically part of standard treatments for communication issues. This approach may enhance physical well-being, potentially supporting better communication indirectly by improving overall health and function. ^{1 2 5 11 12}

Research Team

Jenya Iuzzini-Seigel, PhD

Principal Investigator

Marquette University

Eligibility Criteria

This trial is for children with developmental language disorder (DLD) and those with typical development. It aims to see if exercise improves learning, fitness, and motor skills compared to restful play. Children must be able to participate in physical activities or calm play sessions three times a week for six weeks.

Inclusion Criteria

My child has been diagnosed with developmental language disorder or is developing typically.

My child is between 6 and 8 years old.

Children with normal hearing based on parent report and audiometric screening

Exclusion Criteria

My child has a diagnosis affecting social interactions, like autism.

My child cannot participate due to vision impairments.

My child cannot participate in medical assessments or treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either an exercise program or a restful play program, conducted 3 times per week for 6 weeks

6 weeks

18 visits (in-person)

Follow-up

Participants are monitored for cognitive-linguistic and fitness gains post-treatment

12 weeks

3 visits (in-person)

Treatment Details

Interventions

• Exercise Training

Trial Overview The study tests whether an exercise program involving cardiovascular, agility, balance, strength, and endurance training can benefit children's learning and motor skills more than restful activities like playing with legos or coloring.

Participant Groups

Group I: Exercise Experimental Treatment 1 Intervention

This group will receive treatment 3x/week for 6 weeks

Group II: Restful Play Placebo Group 1 Intervention

This group will receive treatment 3x/week for 6 weeks.

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Findings from Research

The Cardio-Respiratory Exercise Maugeri Algorithm (CREMA) was found to be a feasible and safe method for tailoring rehabilitation exercise programs for 620 outpatients with various heart and lung diseases over a 4-year period.

Patients who underwent rehabilitation showed significant improvements in physical capabilities, particularly those with recent myocardial revascularization, indicating that personalized exercise training can effectively enhance recovery in patients with chronic heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist Driven Rehabilitation Protocol for Patients with Chronic Heart and Lung Diseases: A Real-Life Study. Simonelli, C., Vitacca, M., Ambrosino, N., et al.[2023]

Cardiac rehabilitation is crucial for patients with coronary heart disease, offering significant physiological, psychological, and prognostic benefits, and is structured into three phases: acute care, outpatient, and further conditioning programs.

Physical therapists play a vital role in implementing exercise testing and progressive activity programs, with data from Tufts New England Medical Center showing measurable improvements in cardiovascular health for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation. An overview. Hoskins, TA., Habasevich, RA.[2019]

Cardiac rehabilitation, particularly exercise-based programs, has been shown to improve outcomes for patients who have experienced a myocardial infarction, enhancing functional capacity, psychosocial well-being, and health knowledge.

These rehabilitation programs are generally safe, especially when monitored with telemetry, and the review also highlights the potential benefits for patients beyond those with a history of myocardial infarction, including home-based rehabilitation options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. Greenland, P., Chu, JS.[2019]

A community-based physical rehabilitation program significantly reduced the incidence of major adverse cardiac events (MACE) in patients after percutaneous coronary intervention, with a lower rate of 13.4% compared to 24.4% in the control group over an average follow-up of 25 months.

Patients in the rehabilitation group also showed improved cardiac function and physical stamina, with better left ventricular ejection fraction and 6-minute walk distance at 12 months, indicating the program's efficacy in enhancing recovery post-heart attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Physical Rehabilitation After Percutaneous Coronary Intervention for Acute Myocardial Infarction. Xiao, M., Li, Y., Guan, X.[2022]

Exercise therapy has been found effective for various chronic conditions, including knee osteoarthritis, chronic low back pain, cystic fibrosis, and chronic obstructive pulmonary disease, based on a review of 104 systematic reviews involving rigorous quality assessments.

However, there is insufficient evidence to support the effectiveness of exercise therapy for conditions like neck pain and acute low back pain, indicating that while exercise can be beneficial, it may not be suitable for all musculoskeletal or respiratory disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of exercise therapy: a best-evidence summary of systematic reviews. Smidt, N., de Vet, HC., Bouter, LM., et al.[2022]

In a study of 35,110 exercise interventions for pediatric cancer patients and survivors, serious adverse events (AEs) were rare, with only six Grade 2-3 AEs reported, resulting in an incidence of 17 per 100,000 interventions, indicating that supervised exercise programs are generally safe.

While Grade 1 AEs, such as muscle soreness and circulatory problems, were more common (2,800 per 100,000 interventions), these were typically mild and likely not directly caused by the exercise, suggesting that exercise can be safely integrated into cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. Gauß, G., Beller, R., Boos, J., et al.[2021]

In a study of 2345 patients with coronary artery disease, attending more sessions of cardiac rehabilitation (CR) was linked to a lower risk of major adverse cardiovascular events (MACEs), with a significant reduction observed in those completing 20 or more sessions.

The relationship between CR dose and MACE risk was linear, meaning that each additional session further decreased the risk, with no upper limit on the benefits of increased participation in CR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose of Cardiac Rehabilitation to Reduce Mortality and Morbidity: A Population-Based Study. Medina-Inojosa, JR., Grace, SL., Supervia, M., et al.[2022]

Exercise prescription for cardiac patients is as individualized as medication, with tailored recommendations based on each patient's needs and limitations, which can help maintain exercise tolerance after cardiovascular events.

Moderate intensity exercise training is safe and effective for improving various health outcomes in patients with coronary artery disease, including functional capacity and psychosocial well-being, making it particularly beneficial for those who were previously sedentary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much exercise is enough for the coronary patient? Franklin, BA.[2019]

Regular exercise significantly benefits patients with heart disease by improving exercise tolerance, controlling risk factors, and potentially influencing the progression of coronary artery disease.

Patients should follow physician-guided exercise plans that include dynamic endurance activities and moderate-intensity circuit weight training, with a recommended duration of 2 to 3 hours per week, while high-risk patients should exercise at lower intensities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. Niederhauser, HU.[2008]

Exercise training and cardiac rehabilitation significantly improve exercise capacity, cardiovascular function, quality of life, and reduce depressive symptoms in patients with cardiovascular diseases, including coronary artery disease and chronic heart failure.

Recommendations for exercise in these patients emphasize tailored programs that include 30-60 minutes of endurance training 3-5 days a week and resistance training 2-3 times a week, focusing on achieving high training intensities for optimal benefits, although more research is needed for specific exercise guidelines in other cardiovascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of characteristics and modalities of physical activity and exercise in the management of cardiovascular health in individuals with cardiovascular disease (Part III). Vanhees, L., Rauch, B., Piepoli, M., et al.[2022]

Therapeutic exercise is essential in rehabilitation for both humans and animals, significantly improving function, performance, and reducing disability, as evidenced by its long-standing use in physical therapy since the early 1900s.

The variety of therapeutic exercises, including balance, strength, and endurance activities, targets specific goals such as restoring movement, enhancing strength, and preventing health issues, demonstrating its comprehensive benefits in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic exercise. Saunders, DG.[2019]

This study aims to provide a comprehensive overview of how exercise therapy is conducted in rehabilitation facilities across Germany, using a mixed-methods approach that combines quantitative surveys and qualitative discussions with practitioners.

The findings will help identify facilitators and barriers in exercise therapy practices, which can inform the development and improvement of quality exercise therapy programs tailored to chronic health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise therapy in medical rehabilitation: Study protocol of a national survey at facility and practitioner level with a mixed method design. Geidl, W., Deprins, J., Streber, R., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Therapist Driven Rehabilitation Protocol for Patients with Chronic Heart and Lung Diseases: A Real-Life Study. [2023]

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

Cardiac rehabilitation. An overview. [2019]

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

Efficacy of cardiac rehabilitation services. With emphasis on patients after myocardial infarction. [2019]

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

Community-Based Physical Rehabilitation After Percutaneous Coronary Intervention for Acute Myocardial Infarction. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of exercise therapy: a best-evidence summary of systematic reviews. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events During Supervised Exercise Interventions in Pediatric Oncology-A Nationwide Survey. [2021]

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

Dose of Cardiac Rehabilitation to Reduce Mortality and Morbidity: A Population-Based Study. [2022]

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

How much exercise is enough for the coronary patient? [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

[Heart patient and sports]. [2008]

10. England pubmed.ncbi.nlm.nih.gov

Importance of characteristics and modalities of physical activity and exercise in the management of cardiovascular health in individuals with cardiovascular disease (Part III). [2022]

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

Therapeutic exercise. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise therapy in medical rehabilitation: Study protocol of a national survey at facility and practitioner level with a mixed method design. [2023]