Breathwork for older adults after knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial explores a brief 5-minute asynchronous breathwork session delivered around the time of total knee arthroplasty to see if it can modulate the surgical stress response and improve recovery. In addition, participants perform a 5-minute asynchronous card game video to compare effects on recovery outcomes. Eligible participants are adults aged 65 or older scheduled for elective TKA, with good overall health and no conditions that would confound breathing or cortisol regulation. The study is conducted at the University of Arizona and aims to assess feasibility and potential impacts on postoperative recovery, including physiological and psychological well-being. Outcomes of interest include safety, feasibility, and signals of effect on recovery metrics related to SSR and mood.

Why it matters

Who can join: the full rules

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)

Where it's running

• The University of Arizona
  Tucson, Arizona, United States Recruiting

Study contacts

• Principal investigator: Devon E Cobos Garcia, PhD Candidate — University of Arizona
• Study coordinator: Devon E Cobos Garcia, PhD Candidate, MS, BSN
• Email: decg0131@arizona.edu
• Phone: 904-477-7960

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.