Exercise for Preterm Birth

Overseen By Heather L Vellers, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Texas Tech University

Disqualifiers: Bronchopulmonary hyperplasia, cardiovascular, metabolic, 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: 1

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why young adults born very preterm (before 32 weeks) struggle to improve their fitness levels through aerobic exercise. Researchers focus on the mitochondria, the energy producers in cells, and their DNA to understand this issue better. Participants will either undergo a 16-week aerobic exercise program (also referred to as physical activity, workout, or fitness training) or provide samples for mitochondrial DNA analysis. The trial seeks inactive young adults, aged 18-35, who were born preterm or at full term. The goal is to identify potential markers linked to exercise response and heart disease risk in those born preterm. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve health outcomes for those born preterm.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise program is safe for young adults born very preterm?

Research shows that aerobic exercise is usually safe and beneficial for most people. Studies have found that physical activity during pregnancy can lead to fewer health issues and better overall well-being. Although these studies focus on pregnant women, they suggest that aerobic exercise is generally well-tolerated by many people.

This trial focuses on young adults born very early, aiming to improve their fitness through aerobic exercise. While specific studies on this exact group are lacking, the general safety of aerobic exercise is reassuring. Similar exercise programs have not reported major problems.

Although more research is needed to understand how this group specifically responds, current evidence suggests that aerobic exercise is a safe way to boost health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of aerobic exercise as a method to improve outcomes for individuals born prematurely, a group that typically faces various health challenges. Unlike standard treatments for preterm birth, which often involve medical or surgical interventions, this approach focuses on a non-invasive lifestyle modification that could enhance overall health and fitness. Additionally, the trial includes mitochondrial DNA sequencing to uncover genetic variants specific to those born prematurely, which could lead to personalized treatment strategies in the future. This combination of exercise and genetic analysis offers a fresh perspective on managing and understanding the long-term effects of preterm birth.

What evidence suggests that this trial's treatments could be effective for improving fitness in young adults born very preterm?

This trial will compare the effects of aerobic exercise training with mitochondrial DNA sequencing in individuals born prematurely. Research has shown that aerobic exercise greatly benefits health, but young adults born very early often struggle to improve fitness through exercise. This difficulty may stem from mitochondrial problems, as mitochondria function like the power plants of cells. Mitochondrial issues are common in those born preterm and might influence their exercise response. While direct evidence is lacking that exercise can enhance fitness for this group, understanding mitochondrial DNA could lead to better solutions. The goal is to identify specific mitochondrial changes that might improve exercise responses in the future. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for inactive young adults aged 18-35 who were born preterm (before 37 weeks) and their biological mothers, as well as age- and sex-matched controls born at term. Participants must exercise less than 150 minutes per week and pass a health readiness assessment to start moderate-intensity exercise.

Inclusion Criteria

I am cleared to start a moderate-intensity exercise program based on the PAR-Q+ assessment.

I am the biological mother who gave birth to the participant.

I was born before 37 weeks of pregnancy, am 18-35 years old, and exercise less than 150 minutes a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mitochondrial DNA Sequencing

Participants provide a blood or saliva sample for mitochondrial DNA sequencing analysis to assess for variants unique to individuals born prematurely

1 visit

1 visit (in-person)

Aerobic Exercise Training

Participants complete a 16-week aerobic exercise training program

16 weeks

Regular visits for exercise sessions

Follow-up

Participants are monitored for changes in mitochondrial oxidative capacity and maximal aerobic capacity after the training program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise

Trial Overview The study investigates if mitochondrial DNA markers are linked to poor aerobic exercise response in young adults born very preterm. It aims to understand how mitochondrial DNA affects fitness trainability by comparing responses of these individuals with those born at term.

How Is the Trial Designed?

Group I: Aerobic Exercise Training Experimental Treatment 1 Intervention

Participants will be asked to complete a 16-week aerobic exercise training program.

Group II: Mitochondrial DNA Sequencing Active Control 1 Intervention

Participants will be asked to provide a blood or saliva sample for mitochondrial DNA sequencing analysis to assess for variants unique to individuals born prematurely.

Who Is Running the Clinical Trial?

Texas Tech University

Lead Sponsor

Trials

89

Recruited

10,300+

Published Research Related to This Trial

Resistance training (RT) is the only non-drug method proven to effectively counteract age-related declines in muscle mass, strength, and power, while also reducing risks of various health issues like cardiovascular disease and depression.

Minimal-dose RT strategies, which involve lower training volumes and can be performed with minimal equipment, are effective in improving strength and functional ability, making it easier for more people to participate and potentially enhancing overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. Fyfe, JJ., Hamilton, DL., Daly, RM.[2022]

Early upper-limb exercise training combined with general physiotherapy significantly improves exercise capacity in patients recovering from acute respiratory failure after mechanical ventilation, as shown by better performance in both incremental and endurance tests.

The study indicates that early exercise training is feasible and beneficial in respiratory intermediate ICUs, with improvements in muscle fatigue and dyspnea, particularly in patients with better baseline inspiratory muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supported arm training in patients recently weaned from mechanical ventilation. Porta, R., Vitacca, M., Gilè, LS., et al.[2022]

A study involving 24 children with spastic diplegic cerebral palsy and 12 without neurological impairments found that performing maximum effort exercises did not increase muscle spasticity, as measured by the pendulum test.

The results challenge the traditional belief that resistive exercise exacerbates spasticity in individuals with cerebral palsy, suggesting that such exercises may be safe and not detrimental to muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of quadriceps femoris muscle strengthening exercises on spasticity in children with cerebral palsy. Fowler, EG., Ho, TW., Nwigwe, AI., et al.[2009]

An 8-week study involving 24 children with spastic cerebral palsy found that neither proprioceptive neuromuscular facilitation stretching nor static stretching led to significant improvements in muscle-tendon properties, muscle strength, or ankle joint function.

Both stretching techniques showed high adherence rates (over 93%), but ultimately, the study suggests that manual stretching alone may not be effective for enhancing physical function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight weeks of proprioceptive neuromuscular facilitation stretching and static stretching do not affect muscle-tendon properties, muscle strength, and joint function in children with spastic cerebral palsy. Kruse, A., Habersack, A., Weide, G., et al.[2023]

In a pilot study involving 12 critically ill children in a Pediatric Critical Care Unit, virtual reality exercise using Nintendo Wii™ Boxing was found to be safe, with no adverse events reported during the intervention.

While the VR exercise increased upper limb activity compared to daily activity, challenges in feasibility were noted, as only 8 participants completed the study, indicating potential barriers to implementation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Wii-Hab" in critically ill children: a pilot trial. Abdulsatar, F., Walker, RG., Timmons, BW., et al.[2022]

Short-term intensive exercise training (IET) following hospital discharge significantly improves function in patients with rheumatoid arthritis or osteoarthritis, with benefits observed in range of motion and disability measures up to 52 weeks after the intervention.

The IET group showed faster improvements compared to usual care, particularly in disability scores, with a significant mean difference of -5.5 in the McMaster Toronto Arthritis Patient Preference Disability Questionnaire at 3 weeks, indicating a clinically relevant impact on patient function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthritis patients show long-term benefits from 3 weeks intensive exercise training directly following hospital discharge. Bulthuis, Y., Drossaers-Bakker, KW., Taal, E., et al.[2022]

Patients recovering from critical illness engaged in very limited physical activity, spending less than 5% of their day active during their hospital stay, despite rehabilitation efforts.

Physical activity significantly increased from the ICU to the ward, with an average increase of 35 minutes per day, highlighting the importance of early rehabilitation to enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity of patients with critical illness undergoing rehabilitation in intensive care and on the acute ward: An observational cohort study. Rollinson, TC., Connolly, B., Berlowitz, DJ., et al.[2022]

In a study involving 6 adults with spastic quadriplegia, passive range of motion (PROM) exercises did not show a significant effect on joint flexibility, as measured by goniometric assessments.

The research utilized a single-subject design, revealing that there was no difference in lower-extremity measurements between phases with and without PROM exercises, suggesting that these exercises may not be effective for improving joint range in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of passive range of motion exercises on lower-extremity goniometric measurements of adults with cerebral palsy: a single-subject design. Cadenhead, SL., McEwen, IR., Thompson, DM.[2011]

In a study of 38 children with unilateral cerebral palsy, those who participated in 24 sessions of plyometric exercise over 3 months showed significant improvements in the structure and function of their plantar flexor muscles compared to a control group that received traditional therapy.

Plyometric exercise led to notable changes in muscle and tendon characteristics, such as increased muscle thickness and tendon length, which could enhance muscular efficiency and overall physical performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical and Morphological Changes of the Plantar Flexor Musculotendinous Unit in Children with Unilateral Cerebral Palsy Following 12 Weeks of Plyometric Exercise: A Randomized Controlled Trial. Elnaggar, RK., Alghamdi, MS., Alenazi, AM., et al.[2022]

Whole body vibration training (WBVT) significantly improved the 6 Minute Walking Distance (6MWD) by an average of 35 meters in COPD patients after 12 weeks, indicating its efficacy as a rehabilitation method.

Both WBVT and resistance training (RT) showed similar improvements in exercise capacity and quality of life, but only 30% of patients in the WBVT group reached the minimally clinically important difference (MCID) for 6MWD, suggesting that while effective, WBVT may not be as impactful as RT in achieving significant clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Whole Body Vibration in Patients With COPD. Salhi, B., Malfait, TJ., Van Maele, G., et al.[2022]

Resistance training (RT) significantly reduces all-cause mortality and the incidence of cardiovascular disease while improving physical functioning in adults, based on an analysis of 11 systematic reviews involving over 382,000 participants.

Although adverse events were not consistently reported, serious adverse events related to RT were uncommon, suggesting that the benefits of resistance training outweigh the potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. El-Kotob, R., Ponzano, M., Chaput, JP., et al.[2021]

The study demonstrated that the Rating of Perceived Exertion (RPE) is a valid and reliable measure for assessing the intensity of isometric wall squats, effectively correlating with physiological responses like heart rate and blood pressure.

RPE can distinguish between different knee angles during wall squats with a precision of 10 degrees, making it a useful tool for patients and practitioners to monitor exercise intensity and its effects on blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and reliability of RPE as a measure of intensity during isometric wall squat exercise. Lea, JWD., O'Driscoll, JM., Coleman, DA., et al.[2022]

A study involving 90 patients with severe respiratory failure showed that implementing an early exercise safety management program during mechanical ventilation significantly improved mental health, lung function, and overall quality of life compared to standard care.

The early exercise program also resulted in a lower incidence of complications (24.44% vs. 57.78%), highlighting its safety and effectiveness in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of early exercise safety management in patients undergoing mechanical ventilation in intensive care unit]. Zhang, L., Yan, R., Zhou, Y., et al.[2020]

The SPRINT protocol, which combines aerobic and resistive training using a flywheel device, was tested in a pilot study with five healthy male subjects over 2 weeks, showing that while physiological effects were similar, the addition of a VR simulation improved motivation, mood, and overall well-being during exercise.

The study suggests that incorporating a VR 'exergaming' simulation with real-time biometric feedback could enhance the psychological benefits of exercise, making it a valuable tool for astronauts facing isolation during long-duration space missions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality "exergames": A promising countermeasure to improve motivation and restorative effects during long duration spaceflight missions. Keller, N., Whittle, RS., McHenry, N., et al.[2022]

In a study of 91 mechanically ventilated patients, exercise rehabilitation was found to be safe, with only 10 minor adverse events (0.0182%) reported, indicating a low risk associated with this intervention.

The results support the consensus recommendations for exercise rehabilitation in intensive care, suggesting that even patients on moderate vasoactive support can safely begin rehabilitation, highlighting the potential for broader application of these guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When is it safe to exercise mechanically ventilated patients in the intensive care unit? An evaluation of consensus recommendations in a cardiothoracic setting. Boyd, J., Paratz, J., Tronstad, O., et al.[2018]

Citations

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Physical activity and pregnancy outcomes: An expert review These data suggest an association between increased physical activity and a reduced risk of preterm birth with no concern for harm with ...

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Association of physical activity level during pregnancy with ... Systematic review and meta-analysis found that higher level of physical activity is associated with reduced risk of preterm birth [21], ...

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Physical activity outcomes following preterm birth Children born preterm may be at risk for reduced levels of PA as they have increased respiratory symptoms as well as decrements in lung function and exercise ...

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Physical activity and preterm birth: risk factor or benefit? Higher levels of leisure-time physical activity during pregnancy reduced the risk of preterm birth per three-hour increment, whereas physical ...

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Physical Activity and Exercise During Pregnancy and the ... Physical activity and exercise in pregnancy are associated with minimal risks and have been shown to benefit most women.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030121152400352X

Exercise during pregnancy Dose: Influence on preterm ... Exercise during pregnancy tended to result in later preterm deliveries (p = 0.08). Greater prenatal exercise volume and duration were associated with reduced ...

8. academic.oup.com academic.oup.com/aje/article/167/7/859/83542

Physical Exercise during Pregnancy and the Risk of Preterm ... Results showed a reduced risk of preterm birth among the almost 40% of women who engaged in some kind of exercise during pregnancy in comparison ...