NCT07464860 · University of Arizona
Feasibility of Breathwork Intervention With Older Adults After Knee Surgery
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
A 5-minute Asynchronous Breathwork Intervention
Participants will be guided through the Box Breathing intervention with a pre-recorded YouTube video created by the PI. The video will be embedded into REDCap and delivered online asynchronously to provide flexibility and will be the same for all six sessions. The video will consist of a simple box pattern displayed on the screen with movement around the box that coincides with the PI's voiceover recording of the Box Breathing sequence. . Each session will be five minutes in length, with each section (e.g., inhalation, exhalation, breath retention) of the exercise lasting approximately four seconds. The sequence of each Box Breathing session is performed by breathing through the nose as follows: inhale for 4 seconds, hold the inhalation (lungs "full") for 4 seconds, exhale for 4 seconds, hold the exhalation (lungs "empty") for 4 seconds, and then return to inhaling for 4 seconds. Participants will be encouraged to exhale through the mouth if exhaling through the nose is not accessible.
BEHAVIORAL
A 5-minute Asynchronous Card Game Video
Participants will watch the TriPeaks video, a pre-recorded YouTube video created by the PI. The video will be embedded into REDCap and delivered online asynchronously to provide flexibility and will be the same for all six sessions. The video will consist of a screen recording of the PI playing the card game TriPeaks. Each session will be five minutes in length to match the Box Breathing intervention dosage and delivery.
Primary outcome measures
Study Feasibility via Recruitment
Time frame: Through study completion, an average of 4.5 months
Enroll a nationwide sample of N=32 older adults (≥65 years of age) scheduled for elective Total Knee Arthroplasty that meet eligibility criteria within the rolling three- to six-month recruitment campaign period
Study Feasibility via Retention
Time frame: Through study completion, an average of 4.5 months
Overall study attrition is ≤25%, with no more than 10% differential attrition between the experimental and control groups, calculated by dividing the number of participants who drop out by total participants enrolled in the study.
Study Feasibility via Receipt of Saliva Samples
Time frame: Through study completion, an average of 4.5 months
Study team receipt of 80% of salivary cortisol samples collected.
Study Feasibility via Postoperative Morbidity Survey Completion
Time frame: Through study completion, an average of 4.5 months
Collection of 80% of postoperative morbidity surveys (Numeric Rating Scale, 11-point; State Anxiety Inventory; Patient-Reported Outcomes Measurement Information System Depression - Short Form 4a; and Quality of Recovery, Short Form)
Box Breathing Intervention Feasibility via Box Breathing Completion Survey
Time frame: Through study completion, an average of 4.5 months
80% of the 1-item Box Breathing Completion surveys completed with "Yes", with "Yes" answers indicating the participant completed the Box Breathing session for that day (Postoperative Day 2 and 3) and time (Morning, Afternoon, Evening), and "No" indicating the participant did not complete the Box Breathing session for that day (Postoperative Day 2 and 3) and time (Morning, Afternoon, Evening).
Box Breathing Intervention Feasibility via Feasibility of Intervention Measure (FIM)
Time frame: Measured one time on the evening of Postoperative Day 3
Score ≥15 on the FIM for Box Breathing Intervention per participant. The FIM is a 4-item, Likert-type survey used to measure implementation success. The score range is 4 to 20. The higher the score, the greater the feasibility of implementation.
Box Breathing Intervention Acceptability via Acceptability of Intervention Measure (AIM)
Time frame: Measured one time on the evening of Postoperative Day 3
Score ≥15 on the AIM for Box Breathing Intervention per participant. The AIM is a 4-item, Likert-type survey used to measure implementation success. The score range is 4 to 20. The higher the score, the greater the acceptability of implementation.
Box Breathing Intervention Appropriateness via Intervention Appropriateness Measure (IAM)
Time frame: Measured one time on the evening of Postoperative Day 3
Score ≥15 on the AIM for Box Breathing Intervention per participant. The IAM is a 4-item, Likert-type survey used to measure implementation success. The score range is 4 to 20. The higher the score, the greater the appropriateness of implementation.
TriPeaks Video Attention Control Task Feasibility via Attention Control Task Completion Survey
Time frame: Through study completion, an average of 4.5 months
80% of the 1-item Attention Control Task Completion surveys completed with "Yes", with "Yes" answers indicating the participant completed the Attention Control Task (TriPeaks Video) session for that day (Postoperative Day 2 and 3) and time (Morning, Afternoon, Evening), and "No" indicating the participant did not complete the Attention Control Task (TriPeaks Video) session for that day (Postoperative Day 2 and 3) and time (Morning, Afternoon, Evening).
TriPeaks Video Attention Control Task Feasibility via Feasibility of Intervention Measure (FIM)
Time frame: Measured one time on the evening of Postoperative Day 3
Score ≥15 on the FIM for Attention Control Task (TriPeaks Video) per participant. The FIM is a 4-item, Likert-type survey used to measure implementation success. The score range is 4 to 20. The higher the score, the greater the feasibility of implementation.
TriPeaks Video Attention Control Task Acceptability via Acceptability of Intervention Measure (AIM)
Time frame: Measured one time on the evening of Postoperative Day 3
Score ≥15 on the AIM for Attention Control Task (TriPeaks Video) per participant. The AIM is a 4-item, Likert-type survey used to measure implementation success. The score range is 4 to 20. The higher the score, the greater the acceptability of implementation.
TriPeaks Video Attention Control Task Appropriateness via Intervention Appropriateness Measure (IAM)
Time frame: Measured one time on the evening of Postoperative Day 3
Score ≥15 on the IAM for Attention Control Task (TriPeaks Video) per participant. The IAM is a 4-item, Likert-type survey used to measure implementation success. The score range is 4 to 20. The higher the score, the greater the appropriateness of implementation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Tucson, Arizona
Related conditions & keywords
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Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations