NCT07464860 Feasibility of Breathwork Intervention With Older Adults After Knee Surgery
| NCT ID | NCT07464860 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Arizona |
| Condition | Surgical Stress Response |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2026-10-06 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2026-07-01 with a primary completion date of 2026-10-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Postoperative complications after surgical procedures, including following total knee arthroplasty (TKA), have a negative impact on the health and well-being of surgical patients. Older adults (≥65 years) are particularly vulnerable to postoperative complications and their associated morbidities due to the biological aging process. Older adults comprise nearly half of surgical patients worldwide, and this number is expected to increase in the next 10-20 years as the aging population continues to grow. TKA is the most common procedure undergone by older adults, and the rate of TKA procedures is also expected to rise. Despite perioperative guidelines and protocols to prevent postoperative complications, the prevalence of postoperative complications following TKA is approximately 12%. Given these statistics, millions of older adults undergoing TKA may be at risk for postoperative complications and their associated morbidities in the coming decades. Therefore, additional interventions are needed to combat postoperative complications in this population. The body's natural response to surgery, also known as the surgical stress response (SSR), contributes to postoperative complications through complex mechanisms involving the autonomic nervous system (ANS). Increased sympathetic nervous system (SNS) activity, or the body's fight-or-flight response, causes dysregulation in feedback systems that regulate the stress response, potentially leading to poorer outcomes. Interventions, such as breathwork, that induce the parasympathetic nervous system (PNS), or the body's rest-and-digest response, have been shown to balance the ANS, regulate stress biology, and improve outcomes. This study will examine the feasibility of adding a breathwork intervention (Box Breathing), compared to an attention control, to standard perioperative care for older adults undergoing TKA. This study will also examine the proof of concept that Box Breathing, compared to an attention control, may help regulate the SSR by assessing an objective measure of stress-related biology, diurnal cortisol rhythm, and gathering self-report information on pain, anxiety, depression, and quality of recovery following TKA.
Eligibility Criteria
Adults aged 65 years or older of any sex, gender and ethnic background who meet the following criteria will be eligible to enroll in the present study: Inclusion Criteria: * scheduled for elective TKA within the next week to two months (can be second knee, but cannot be a revision of the original knee) * self-reported good health, including denial of debilitating illness that may affect participation in or be potentially exacerbated by deep, controlled breathing (i.e., chronic obstructive pulmonary disorder \[COPD\], symptomatic or advanced heart failure, complete heart block, glaucoma, epilepsy) * denial of conditions that alter cortisol release or that require corticosteroid therapy (i.e., Cushing's syndrome, Addison's disease, pituitary tumors, adrenal gland tumors, asthma) * denial of severe psychiatric or cognitive conditions that warrant the need for a durable power of attorney (DPOA) * able to understand written and verbal English. Exclusion Criteria: * currently taking oral, injectable, intranasal, topical, or inhaled corticosteroid medications (i.e., prednisone, hydrocortisone, dexamethasone, methylprednisolone, methylprednisolone acetate, triamcinolone, betamethasone, mometasone, fluticasone, budesonide, clobetasol) * do not have the technology requirements to complete data collection (i.e., participant does not have a smartphone, tablet, laptop, or desktop computer; lack of reliable internet) The following exclusion criteria may affect participants' ability to remain in the study following enrollment: • Development of complications during surgery that require prolonged hospitalization into Postoperative Day (POD) 2 (e.g., postoperative intubation and ventilation requirements, intractable pain, intractable nausea/vomiting, signs of infection or sepsis)
Contact & Investigator
Devon E Cobos Garcia, PhD Candidate
PRINCIPAL INVESTIGATOR
University of Arizona
Frequently Asked Questions
Who can join the NCT07464860 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Surgical Stress Response. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07464860 currently recruiting?
Yes, NCT07464860 is actively recruiting participants. Contact the research team at decg0131@arizona.edu for enrollment information.
Where is the NCT07464860 trial being conducted?
This trial is being conducted at Tucson, United States.
Who is sponsoring the NCT07464860 clinical trial?
NCT07464860 is sponsored by University of Arizona. The principal investigator is Devon E Cobos Garcia, PhD Candidate at University of Arizona. The trial plans to enroll 32 participants.