Modulating Locomotor-Respiratory Coupling Through Adaptive Exoskeleton Assistance in Patients With COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Nebraska
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Respiratory Rate and Timing
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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^
- •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.
Arms & Interventions
Standard Walking (No Hip Exoskeleton)
Subjects will walk on a treadmill at a preferred speed.
Hip Exoskeleton-Assisted Walking
Subjects will walk on a treadmill while wearing a hip exoskeleton providing them assistance.
Intervention: Hip Exoskeleton-Assisted Walking (Device)
Outcomes
Primary Outcomes
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.
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).
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)
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.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Farahnaz Fallahtafti
Assistant Professor
University of Nebraska