45 Participants Needed

Exercise for Preterm Birth

HL
Overseen ByHeather L Vellers, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Texas Tech University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for Preterm Birth?

Research shows that exercise can be beneficial in various medical settings, such as helping arthritis patients improve after hospital discharge and supporting recovery in critically ill patients. This suggests that exercise might also help improve outcomes for preterm birth, although direct evidence is not provided.12345

Is exercise generally safe for humans?

Research shows that exercise, including resistance training, is generally safe for adults and can improve health outcomes like reducing mortality and cardiovascular disease. Serious adverse events are not common, although they are not always consistently reported in studies.678910

How does exercise as a treatment for preterm birth differ from other treatments?

Exercise for preterm birth is unique because it focuses on physical activity to potentially improve outcomes, unlike other treatments that might involve medication or medical procedures. This approach is non-invasive and leverages the body's natural ability to adapt and strengthen through regular movement.1112131415

What is the purpose of this trial?

Young adults born very preterm (32 weeks gestation or earlier) do not respond well to aerobic exercise training, meeting the recommendations set by the Physical Activity Guidelines for Americans, where they do not increase their fitness level (or cardiorespiratory fitness). Thus, they do not receive the health benefits of exercise. Achieving physical fitness through aerobic exercise training is the most cost-effective method for preventing and treating many diseases. Young adults born very preterm also have a higher risk of these conditions. Thus, their inability to respond to increase their fitness is a major problem.One likely explanation for poor exercise trainability and increased heart disease risk in young adults born very preterm is the effect of the early birth on the major energy producers in all our cells: Mitochondria. During late-stage gestation, mitochondria change from relying on sugar as a major fuel source to fat. Unfortunately, individuals born very preterm miss this transition in fuel source reliance, which causes significant stress and damage to mitochondria. Mitochondria are critical for post-natal organ development; thus, it is thought that preterm birth-induced mitochondrial dysfunction is the underlying cause of poor trainability and high disease risk in young adults born very preterm. Indeed, mitochondrial dysfunction is evident in these individuals.To date, there is not a way to help young adults born preterm improve their fitness level. One likely target is in the mitochondria: it's DNA. Mitochondrial DNA helps determine how mitochondria function and can be damaged under stress. Our goal in this proposed work is to determine the role of mitochondrial DNA in mitochondrial dysfunction and its link to their poor trainability.Questions:1. Are there mitochondrial DNA markers linked to mitochondrial dysfunction and poor exercise trainability in young adults very born preterm?2. Do mitochondrial DNA in young adults born very preterm respond differently to aerobic exercise training than those born at term?The investigators expect this work will show mitochondrial DNA changes linked to mitochondrial dysfunction and poor trainability, which can be used for future targets to improve health. This work supports AHA mission by helping to identify a marker in individuals born very preterm linked to their higher heart disease risk and death early in life.

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Aerobic Exercise TrainingExperimental Treatment1 Intervention
Participants will be asked to complete a 16-week aerobic exercise training program.
Group II: Mitochondrial DNA SequencingActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Tech University

Lead Sponsor

Trials
89
Recruited
10,300+

Findings from Research

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.
Supported arm training in patients recently weaned from mechanical ventilation.Porta, R., Vitacca, M., Gilè, LS., 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.
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]
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.
"Wii-Hab" in critically ill children: a pilot trial.Abdulsatar, F., Walker, RG., Timmons, BW., et al.[2022]

References

Supported arm training in patients recently weaned from mechanical ventilation. [2022]
When is it safe to exercise mechanically ventilated patients in the intensive care unit? An evaluation of consensus recommendations in a cardiothoracic setting. [2018]
"Wii-Hab" in critically ill children: a pilot trial. [2022]
Arthritis patients show long-term benefits from 3 weeks intensive exercise training directly following hospital discharge. [2022]
Physical activity of patients with critical illness undergoing rehabilitation in intensive care and on the acute ward: An observational cohort study. [2022]
[Application of early exercise safety management in patients undergoing mechanical ventilation in intensive care unit]. [2020]
Resistance training and health in adults: an overview of systematic reviews. [2021]
Validity and reliability of RPE as a measure of intensity during isometric wall squat exercise. [2022]
Virtual Reality "exergames": A promising countermeasure to improve motivation and restorative effects during long duration spaceflight missions. [2022]
Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
The effect of quadriceps femoris muscle strengthening exercises on spasticity in children with cerebral palsy. [2009]
12.United Statespubmed.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. [2011]
Effects of Whole Body Vibration in Patients With COPD. [2022]
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. [2023]
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. [2022]
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