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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241419
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Frailty Behavioral: High Intensity Walking Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of High Intensity Walking in Older Adults in the Pre-operative Period
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Phenotypic Frailty Criteria [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: 8 weeks ]
    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.

  2. Berg Balance Scale [ Time Frame: 8 weeks ]
    The Berg balance scale will be used to assess the subject's balance at baseline and 8 weeks.

  3. 6 minute walk test [ Time Frame: 8 weeks ]
    The distance a subject can walk in 6 minutes will be measured at baseline and 8 weeks.

  4. PROMIS Global Health [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241419


Contacts
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Contact: Michelle Martinchek, MD (773) 702-8840 mmartinchek@medicine.bsd.uchicago.edu

Locations
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United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Michelle Martinchek, MD    773-702-8840    mmartinchek@medicine.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Michelle Martinchek, MD University of Chicago
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04241419    
Other Study ID Numbers: IRB19-0468
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
ESRD
Thoracic Disease
Kidney Transplant
Additional relevant MeSH terms:
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Frailty
Pathologic Processes