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NCT Number: NCT07703527

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

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hip Exoskeleton-Assisted Walking

Device

The intervention is a wearable hip exoskeleton designed to provide assistive torque during treadmill walking. During the assisted walking condition, participants will wear the exoskeleton secured around the waist and thighs. The device will provide powered assistance to the hip joints during walking to reduce the physical demand of locomotion. Participants will complete a 30-minute treadmill walking session at an individualized workload determined during an initial exercise calibration visit. The effects of hip exoskeleton assistance will be evaluated by comparing physiological, respiratory, biomechanical, and exercise tolerance outcomes with a standard walking condition performed without exoskeleton assistance.

Primary outcomes

  1. Respiratory Rate and Timing

    Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.

    Measured continuously in real-time using Respiratory Inductance Plethysmography bands worn around the chest and abdomen.

  2. Locomotor-Respiratory Coupling (LRC) Ratios

    Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.

    Quantifies the frequency coupling and synchronization between breathing cycles (via RIP bands) and walking cycles (via an SMTEC footswitch system to detect heel strikes).

  3. Dyspnea (Perceived Breathlessness)

    Time frame: Assessed at the end of each treadmill walking bout during the 30-minute exercise session.

    Evaluated at the end of each exercise bout using the Modified Borg Scale, ranging from 0 (no breathlessness) to 10 (maximum breathlessness)

  4. Dynamic Hyperinflation

    Time frame: Measured via spirometry at baseline (pre-exercise) and immediately following the treadmill walking session.

    Evaluated by monitoring the reduction in Inspiratory Capacity (the maximum volume of air inhaled after a regular, calm exhalation) via baseline and post-exercise spirometry.

  5. Walking Kinematics

    Time frame: Continuously recorded during the active 30-minute treadmill walking period in each session.

    Captured at 100 Hz using a 17-camera high-speed digital motion capture system with reflective anatomical markers placed on the lower limbs.

  6. Total Walking Time

    Time frame: Recorded as the exact cumulative duration of all active walking bouts during the 30-minute session.

    Measured precisely using digital stopwatches to record the exact duration of walking bouts during the 30-minute session.

  7. Metabolic Cost / Metabolic Equivalents of Task (METs)

    Time frame: Continuous assessment during the 30-minute treadmill walking bout within each single-day experimental session.

    Determined by measuring net O2 consumption and CO2 production using indirect calorimetry.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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