Feasibility of Breathwork Intervention With Older Adults After Knee Surgery

Recruiting now · Not applicable

Conditions studied: Surgical Stress Response, Stress Physiological, Stress Physiology, Stress Psychological, Breathing Techniques, Breathing Exercises, Hypothalamic Pituitary Adrenal, Relaxation, Relaxation Therapy, Cortisol, Postoperative Pain, Postoperative Anxiety, Postoperative Depression, Quality of Recovery (QoR-15)

In brief

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.

Key facts

Study ID

NCT07464860

Run by

University of Arizona

People needed

32

Starts

2026-07-01

Expected to finish

2026-11-30

Last updated by the study team

2026-07-06

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• The University of Arizona — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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