An interventional study of High Intensity Walking in Frailty, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by University of Chicago · Not applicable, Interventional, and Prevention
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.
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.
1,199 studies on the registry are indexed under Frailty; 430 are open to participants now.
This study's enrollment of 7 is below the median of 80 across 681 interventional studies indexed under Frailty.
Browse Frailty studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will then undergo a 12 session intervention, with two sessions scheduled per week for six weeks. These will be 45 minute sessions, including 15 minutes of a warm-up and cool-down period as well as 30 minutes of walking. The intervention will include various types of over ground walking and stair work.
Behavioral: High Intensity Walking
Participants will then undergo a 12 session intervention, with two sessions scheduled per week for six weeks. These will be 45 minute sessions, including 15 minutes of a warm-up and cool-down period as well as 30 minutes of walking. The intervention will include various types of over ground walking and stair work.
Phenotypic Frailty Criteria
The phenotypic frailty criteria is a validated frailty measurement tool. Phenotypic frailty is a composite that includes grip strength measured via a dynamometer, self-reported weight loss, self-reported exhaustion using a validated two question screen, 15 foot gait speed, and activity level measured by the Minnesota Leisure Time Physical Activity Questionnaire. This will be measured at baseline and 8 weeks.
Time frame: 8 weeks
Short Physical Performance Battery (SPPB)
The SPPB is a mobility assessment which includes gait speed, sit to stand testing, and balance assessment. This will be measured at baseline and 8 weeks.
Time frame: 8 weeks
Berg Balance Scale
The Berg balance scale will be used to assess the subject's balance at baseline and 8 weeks.
Time frame: 8 weeks
6 minute walk test
The distance a subject can walk in 6 minutes will be measured at baseline and 8 weeks.
Time frame: 8 weeks
PROMIS Global Health
The PROMIS Global Health tool measures patient reported physical, mental, and social health, pain, and quality of life. This will be measured at baseline and 8 weeks.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Chicago