RightFit
RecruitingNot applicable

Feasibility of Breathwork Intervention With Older Adults After Knee Surgery

A Box Breathing Intervention and the Surgical Stress Response in Older Adults Undergoing Total Knee Arthroplasty: A Randomized Controlled Feasibility Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether Box Breathing, a controlled breathing exercise, can be added to usual care for adults age 65 or older having total knee replacement. It compares Box Breathing with a group that gets attention instead, looking at stress hormone patterns, pain, anxiety, depression, and recovery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 65 or older, of any sex, gender, or ethnic background.
  • Scheduled for a planned total knee replacement in 1 week to 2 months. Surgery on the second knee is allowed, but surgery to redo an earlier replacement is not.
  • Report good health, with no serious illness that could limit participation or get worse with deep, controlled breathing.
  • Have no condition that changes cortisol, a stress hormone, or requires steroid treatment. Examples include asthma and certain hormone disorders or tumors.
  • Have no severe mental health, memory, or thinking condition that requires someone else to have legal power to make decisions for you.
  • Can understand spoken and written English.

Who can't join

  • Currently use corticosteroid medicines, such as prednisone or hydrocortisone. This includes pills, shots, nose sprays, skin treatments, and inhalers.
  • Do not have a smartphone, tablet, laptop, or desktop computer, or do not have reliable internet.
  • After joining: develop problems during surgery that require staying in the hospital into the second day after surgery. Examples include needing a breathing machine, pain or vomiting that cannot be controlled, or signs of infection.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

AZ