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High Intensity Walking for Pre-Operative Older Adults with Frailty

N/A
Recruiting
Led By Maria L Madariaga, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No obvious contraindication to surgery such as uncontrolled cardiovascular, metabolic, or respiratory disease
Able to ambulate at least 10 feet with moderate assistance (<50% physical assistance)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will study the effects of a high-intensity walking program in older adults who are surgical candidates and have either kidney or thoracic disease, and who are either pre-frail or frail.

Who is the study for?
This trial is for older adults (60+) who can walk at least 10 feet with some help and are considered pre-frail or frail. They should be candidates for major thoracic surgery or kidney transplant but not have uncontrolled health issues that would limit exercise. Surgery shouldn't be planned within the next 8 weeks.Check my eligibility
What is being tested?
The study tests a high intensity walking program to see if it helps older adults who need surgery for kidney or thoracic disease and are slightly weak or very weak. It's a small-scale test before possibly expanding the program.See study design
What are the potential side effects?
While specific side effects aren't listed, high intensity walking could potentially cause muscle soreness, fatigue, joint pain, or exacerbate underlying heart conditions in participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I don't have any major health issues that would prevent me from having surgery.
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I can walk at least 10 feet with some help.
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I am 60 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phenotypic Frailty Criteria
Secondary outcome measures
6 minute walk test
Berg Balance Scale
PROMIS Global Health
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: High Intensity WalkingExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,731 Total Patients Enrolled
3 Trials studying Frailty
355 Patients Enrolled for Frailty
Maria L Madariaga, MDPrincipal InvestigatorUniversity of Chicago

Media Library

High Intensity Walking Clinical Trial Eligibility Overview. Trial Name: NCT04241419 — N/A
Frailty Research Study Groups: High Intensity Walking
Frailty Clinical Trial 2023: High Intensity Walking Highlights & Side Effects. Trial Name: NCT04241419 — N/A
High Intensity Walking 2023 Treatment Timeline for Medical Study. Trial Name: NCT04241419 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this clinical trial?

"Affirmative. Data posted on clinicaltrials.gov reveals that this trial, which was initially announced on May 15th 2019, is currently enrolling patients. The research team needs to recruit a total of 60 participants from 1 location."

Answered by AI

Is recruitment still active for this experiment?

"Clinicaltrials.gov affirms that this trial is presently recruiting, with the initial post having been on May 15th 2019 and an update as recent as September 3rd 2022."

Answered by AI
~15 spots leftby Dec 2025