Study Stopped
Unaware that the devices being used had a shelf life of only 6 months, the physical therapist could no longer assist with the study and did not have anyone to run the physical therapy aspect of the program.
A Pilot Study of High Intensity Walking in Older Adults in the Pre-operative Period
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
January 22, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2023
CompletedOctober 23, 2024
October 1, 2024
4.3 years
January 22, 2020
October 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Secondary Outcomes (4)
Short Physical Performance Battery (SPPB)
8 weeks
Berg Balance Scale
8 weeks
6 minute walk test
8 weeks
PROMIS Global Health
8 weeks
Study Arms (1)
High Intensity Walking
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria L Madariaga, MD
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2020
First Posted
January 27, 2020
Study Start
May 15, 2019
Primary Completion
September 6, 2023
Study Completion
September 6, 2023
Last Updated
October 23, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share