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

Primary Purpose

Frailty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Walking
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring ESRD, Thoracic Disease, Kidney Transplant

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of ChicagoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Intensity Walking

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Berg Balance Scale
The Berg balance scale will be used to assess the subject's balance at baseline and 8 weeks.
6 minute walk test
The distance a subject can walk in 6 minutes will be measured at baseline and 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.

Full Information

First Posted
January 22, 2020
Last Updated
September 8, 2023
Sponsor
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT04241419
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
ESRD, Thoracic Disease, Kidney Transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Walking
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Walking
Intervention Description
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 Measure Information:
Title
Phenotypic Frailty Criteria
Description
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
Secondary Outcome Measure Information:
Title
Short Physical Performance Battery (SPPB)
Description
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
Title
Berg Balance Scale
Description
The Berg balance scale will be used to assess the subject's balance at baseline and 8 weeks.
Time Frame
8 weeks
Title
6 minute walk test
Description
The distance a subject can walk in 6 minutes will be measured at baseline and 8 weeks.
Time Frame
8 weeks
Title
PROMIS Global Health
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria L Madariaga, MD
Phone
(773) 702-5227
Email
mlmadariaga@medicine.bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria L Madariaga, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria L Madariaga, MD
Phone
773-702-5227
Email
mlmadariaga@medicine.bsd.uchicago.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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