A Pilot Study of High Intensity Walking in Older Adults in the Pre-operative Period

  • STATUS
    Recruiting
  • End date
    Dec 28, 2025
  • participants needed
    60
  • sponsor
    University of Chicago
Updated on 19 February 2024

Summary

The purpose of this pilot study is to evaluate a high intensity walking intervention in older surgical candidates with kidney or thoracic disease and pre-frailty or frailty.

Description

As the population ages, there are an increasing number of older adults presenting for surgical evaluation. Frailty evaluation has been recognized as a valuable tool in the pre-operative assessment of older adults. Frailty is a clinical syndrome with multiple causes and contributors that involves poor regulation of multiple physiologic systems and is characterized by reduced strength, endurance, and physiologic function. Frailty is a predictor of poor surgical outcomes in older patients, including post-operative complications, increased length of stay, post-discharge institutionalization, and mortality.Identification of frailty in the pre-operative period can aid in risk assessment and decision making for the procedure, can help inform a plan for post-operative care needs, and may provide a target for pre-operative risk reduction interventions.

Given the association of frailty with poor surgical outcomes and the high prevalence of frailty in surgical candidates, there has been much interest in interventions to mitigate this risk. Exercise interventions in other populations have shown success, although the optimal interventions are unknown. In both thoracic surgery and kidney transplantation, there may be a limited amount of time for intervention prior to the operation and patients often have other commitments, such as frequent medical appointments or dialysis sessions. Thus, a short duration program may be beneficial for these populations. High intensity walking is an approach that has shown to lead to functional gains in as short as 12 sessions. The therapists can also modify a high intensity walking program as needed for patients based on physical limitations, making it widely applicable for frail older adults of varying physical function levels, which is important to our older surgical populations. Surgical patients, which include kidney transplant and thoracic surgery patients, are particularly well suited to a pilot high intensity walking intervention given the high proportion of frailty and pre-frailty in these groups.

In this study, we will examine a 12-week high intensity walking program for frail older surgical candidates.

Details
Condition Frailty
Age 60-100 years
Treatment High Intensity Walking
Clinical Study IdentifierNCT04241419
SponsorUniversity of Chicago
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

years of age or older
Provision of informed consent
No obvious contraindication to surgery such as uncontrolled cardiovascular, metabolic, or respiratory disease
Have either thoracic disease that may require major surgery or End-Stage Renal Disease or Chronic Kidney Disease under consideration for kidney transplant. The kidney transplant patients enrolled must be either a candidate for living donor transplantation or on the expedited deceased donor kidney transplant list, which indicates they are expected to receive an offer in approximately the next 3-5 months
Able to ambulate at least 10 feet with moderate assistance (<50% physical assistance)
Pre-frail or frail on the FRAIL screening tool (1+ positive on this tool)

Exclusion Criteria

Surgery planned within the 8 week study timeframe
Uncontrolled cardiovascular, metabolic, or respiratory disease that limits exercise participation
Resting blood pressure >180/110
Any pre-existing health condition that would make the subject a poor candidate for this study in the opinion of the PI
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