Feasibility of Breathwork Intervention With Older Adults After Knee Surgery

NCT07464860 | Not Yet Recruiting

• 1 other identifier: STUDY00007185
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Recovery (QoR-15); 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

Keywords

Surgical Stress Response; Total Knee Arthroplasty; Hypothalamic-Pituitary-Adrenal Axis; Breathwork; Breathing Exercises; Breathing Techniques; Postoperative Complications; Postoperative Pain; Postoperative Anxiety; Postoperative Depression; Quality of Recovery; Diurnal Cortisol Rhythm

Outcome Measures

Primary Outcomes (12)

• Study Feasibility via Recruitment

  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

  Through study completion, an average of 4.5 months

• Study Feasibility via Retention

  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.

  Through study completion, an average of 4.5 months

• Study Feasibility via Receipt of Saliva Samples

  Study team receipt of 80% of salivary cortisol samples collected.

  Through study completion, an average of 4.5 months

• Study Feasibility via Postoperative Morbidity Survey Completion

  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)

  Through study completion, an average of 4.5 months

• Box Breathing Intervention Feasibility via Box Breathing Completion Survey

  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).

  Through study completion, an average of 4.5 months

• Box Breathing Intervention Feasibility via Feasibility of Intervention Measure (FIM)

  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.

  Measured one time on the evening of Postoperative Day 3

• Box Breathing Intervention Acceptability via Acceptability of Intervention Measure (AIM)

  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.

  Measured one time on the evening of Postoperative Day 3

• Box Breathing Intervention Appropriateness via Intervention Appropriateness Measure (IAM)

  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.

  Measured one time on the evening of Postoperative Day 3

• TriPeaks Video Attention Control Task Feasibility via Attention Control Task Completion Survey

  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).

  Through study completion, an average of 4.5 months

• TriPeaks Video Attention Control Task Feasibility via Feasibility of Intervention Measure (FIM)

  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.

  Measured one time on the evening of Postoperative Day 3

• TriPeaks Video Attention Control Task Acceptability via Acceptability of Intervention Measure (AIM)

  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.

  Measured one time on the evening of Postoperative Day 3

• TriPeaks Video Attention Control Task Appropriateness via Intervention Appropriateness Measure (IAM)

  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.

  Measured one time on the evening of Postoperative Day 3

Secondary Outcomes (5)

• Postoperative Pain as Assessed by the Numeric Rating Scale (NRS), 11-point

  Measured one time on the evening of Postoperative Day 3

• Postoperative Anxiety as Assessed by the State Anxiety Inventory (SAI)

  Measured one time on the evening of Postoperative Day 3

• Postoperative Depression as Assessed by the Patient-Reported Outcomes Measurement Information System Depression - Short Form 4a (PROMIS-Depression-4a)

  Measured one time on the evening of Postoperative Day 3

• Quality of Recovery as Assessed by the Quality of Recovery, Short Form (QoR-15)

  Measured one time on the evening of Postoperative Day 3

• Diurnal Cortisol Rhythm Variables (AUC and slope) as Assessed by Amount of Cortisol in Saliva Samples

  Measured upon waking, 30 minutes after waking, and at bedtime on both Postoperative Day 2 and Day 3

Study Arms (2)

Experimental Group - Box Breathing Intervention

EXPERIMENTAL

Participants in this group will complete a 5-minute virtual Box Breathing session three times a day for two consecutive days following surgery on Postoperative Day 2 and 3. The Box Breathing intervention will be delivered asynchronously via a YouTube video created by the PI and accessed by participants via REDCap. Participants will also collect saliva samples three times per day (upon waking, 30 minutes after waking, and at bedtime) on Postoperative Day 2 and 3 to measure diurnal cortisol rhythm. Participants will fill out a 1-item survey about the Box Breathing session and a 1-item survey about saliva sample collection after each session and collection timepoint. Participants will also complete seven additional surveys regarding pain, anxiety, depression, and quality of recovery on the evening of Postoperative Day 3 after the final Box Breathing session.

Behavioral: A 5-minute Asynchronous Breathwork Intervention

Attention Control Group - TriPeaks Video

ACTIVE COMPARATOR

Participants in this group will complete a 5-minute virtual TriPeaks Video session three times a day for two consecutive days following surgery on Postoperative Day 2 and 3. The TriPeaks Video will be delivered asynchronously via a YouTube video created by the PI and accessed by participants via REDCap. Participants will also collect saliva samples three times per day (upon waking, 30 minutes after waking, and at bedtime) on Postoperative Day 2 and 3 to measure diurnal cortisol rhythm. Participants will fill out a 1-item survey about the TriPeaks Video session and a 1-item survey about saliva sample collection after each session and collection timepoint. Participants will also complete seven additional surveys regarding pain, anxiety, depression, and quality of recovery on the evening of Postoperative Day 3 after the final TriPeaks Video session.

Behavioral: A 5-minute Asynchronous Card Game Video

Interventions

A 5-minute Asynchronous Breathwork Intervention BEHAVIORAL

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.

Experimental Group - Box Breathing Intervention

A 5-minute Asynchronous Card Game Video BEHAVIORAL

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.

Attention Control Group - TriPeaks Video

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

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)
• 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)

Sponsors & Collaborators

• University of Arizona: lead

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MeSH Terms

Conditions

Stress, Psychological; Pain, Postoperative; Postoperative Complications

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Devon E Cobos Garcia, PhD Candidate

  University of Arizona

  PRINCIPAL INVESTIGATOR

• Ruth E Taylor-Piliae, PhD

  University of Arizona

  STUDY CHAIR

• Thaddeus W W Pace, PhD

  University of Arizona

  STUDY CHAIR

Central Study Contacts

Devon E Cobos Garcia, PhD Candidate, MS, BSN

CONTACT

904-477-7960; decg0131@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Organization, Collaborators
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, MS, BSN, RN

Model Details: Two-arm, post-intervention feasibility study

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 11, 2026
• Study Start: April 6, 2026
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03