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Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a wearable device that helps move the hips can improve lung rehab for people with COPD, a long-term lung disease. It is for adults ages 45 to 75 with moderate to severe COPD. Participants walk for 30 minutes on two separate days: once with the device and once without it.

1\) Purpose: To improve pulmonary rehabilitation outcomes for individuals with COPD by evaluating the effectiveness of a hip-assisted exoskeleton during a single pulmonary rehabilitation session. 2) Eligibility criteria: Participants must be between 45-75 years old, any gender, but must have a BMI of less than 35 kg/m\^2, free from co-morbidities that may affect walking patterns, and must have moderate to severe COPD with no other pulmonary or cardiac issues. (Eligible participants will undergo a screening process which includes 6-minute walking test, medical history exam, and spirometry evaluation.) 3) Intervention and evaluation: The experimental collection will be conducted at the Biomechanics Research Building at the University of Nebraska at Omaha. Participants are required to participate in two sessions on two separate days, both including a 30-minute walking session with one session wearing the hip exoskeleton and the other session without the device.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have moderate to severe COPD confirmed by breathing tests.
  • Have an FEV1/FVC ratio below 0.7. This compares how much air you breathe out in one second with the total air you breathe out.
  • After taking medicine that opens the airways, breathe out 30% to 80% of the expected amount in one second.
  • Be 45 to 75 years old.
  • Have a body mass index (BMI) below 35. BMI is a measure based on height and weight.
  • Have no other health conditions that may affect how you walk.
  • Pass screening, including a 6-minute walk test, a medical history review, and a breathing test after airway-opening medicine.
  • Have a doctor's approval to take part.

Who can't join

  • Do not pass the first breathing test.
  • Do not have a doctor's approval to take part.
  • Have a diagnosed lung or heart problem that would make treadmill exercise unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * COPD Diagnosis \& Severity: Documented FEV1/FVC ratio of \< 0.7 and a post-bronchodilator FEV1% predicted between 30% and 80% (classifying as moderate to severe COPD). * Age Requirement: Must be between 45 and 75 years old. * Body Mass Index (BMI): Must have a BMI of less than 35 kg/m\^2. * Medical Clearance \& Screening: Must undergo post-bronchodilator spirometry, successfully pass the screening protocol, and receive formal clearance for participation from a physician. Exclusion Criteria: * Failing to pass the initial spirometry test. * Not being formally cleared for participation by a physician. * Having a diagnosed pulmonary or cardiac issue that would pose a safety hazard during the laboratory treadmill exercise trials.

Study sites (1)

NE