Clinical trial NCT04241419: A Pilot Study of High Intensity Walking in Older Adults in the Pre-operative Period
Official title: A Pilot Study of High Intensity Walking in Older Adults in the Pre-operative Period
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frailty
Keywords: ESRD
Thoracic Disease
Kidney Transplant
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 7
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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, the investigator will examine a 12-week high intensity walking program for frail older surgical candidates.

Eligibility criteria: Inclusion Criteria:

* 60 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

Primary outcomes:
measure: Phenotypic Frailty Criteria
timeFrame: 8 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: 8 weeks
measure: Berg Balance Scale
timeFrame: 8 weeks
measure: 6 minute walk test
timeFrame: 8 weeks
measure: PROMIS Global Health
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Maria L Madariaga, MD
role: PRINCIPAL_INVESTIGATOR
References: