search
Back to results

High Intensity Walking to Reduce Frailty

Primary Purpose

Frailty

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Walking
Casual Speed Walking
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Receiving services from CJE SeniorLife
  • Pre-frailty or frailty as determined on the SHARE-FI.
  • Able to ambulate at least 10 feet with moderate assistance (<50% physical assistance) or less. Participants will be able to use their assistive device (e.g. cane or walker) during sessions.
  • > 65 years of age
  • Provision of informed consent and clearance for participation as determined by the Exercise and Screening for You (EASY)

Exclusion Criteria:

  • Uncontrolled cardiovascular, metabolic, renal, or respiratory disease that limits exercise participation (e.g., previous heart attack within 3 months of enrollment or uncontrolled diabetes)
  • Resting blood pressure > 180/110 mmHg.59

Sites / Locations

  • Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Intensity Walking

Casual Speed Walking

Arm Description

HIW (70-80% Heart Rate max)

Self selected pace

Outcomes

Primary Outcome Measures

Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)
Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity

Secondary Outcome Measures

Improved mobility as measured by gait speed
Measures related to overall health and mobility
Improved mobility as measured by 6 Minute Walk Test
Measures related to mobility
Improved mobility as measured by Time Up and Go
Measures related to mobility
Improved physical function on the Short Physical Performance Battery
Provide an overall assessment of functional status and physical performance
Improved balance as measured by the Berg Balance Scale
The Berg Balance Scale is a valid and reliable 14 item tool to evaluate static and dynamic balance among older adults. Minimum Score 0 to Maximum Score 56. • Score of < 45 indicates individuals may be at greater risk of falling
Monthly self reports of Health Care Utilization
Monthly self-reports of number of falls, number of hospitalizations, and number of emergency room visits
Patient Reported Outcomes Measure Information System (PROMIS) Global Health
assess subjective measures of physical and mental health, pain, and quality of life

Full Information

First Posted
October 12, 2018
Last Updated
March 2, 2021
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT03709251
Brief Title
High Intensity Walking to Reduce Frailty
Official Title
High Intensity Walking to Reduce Frailty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 safety precautions and public health guidelines, the study was terminated early.
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
March 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

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 study is to evaluate a physical therapist (PT) led gait training intervention for 100 older adults with pre-frailty or frailty. The goals of this study are To determine the effect of gait training intensity on frailty, mobility, physical functioning, and quality of life, as well as balance and healthcare utilization.
Detailed Description
Frailty is a leading cause of dependency among older adults, affects up to 60% of older adults, and is associated with an increased risk for falls, hospitalizations, institutionalization, and death. Exercise is the most widely recommended treatment for improving physical function among the frailty, but the optimal type or intensity of exercise is unknown. Walking is a preferred physical activity among older adults, however, there are no clear guidelines on the best intensity of walking to reduce frailty. The specific goal of this project is to compare a high intensity walking (HIW) intervention (70-80% of heart rate maximum) to a moderate intensity walking (MIW) intervention (50-60% of heart rate maximum) for pre-frail or frail older adults to determine the impact on frailty, mobility, balance, quality of life, and healthcare utilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Walking
Arm Type
Experimental
Arm Description
HIW (70-80% Heart Rate max)
Arm Title
Casual Speed Walking
Arm Type
Experimental
Arm Description
Self selected pace
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Walking
Intervention Description
Intense walking activity at an intensity of 70-80% of the maximum heart rate
Intervention Type
Behavioral
Intervention Name(s)
Casual Speed Walking
Intervention Description
Moderate intensity (50-60% of Heart Rate maximum)
Primary Outcome Measure Information:
Title
Change in frailty as measured by the Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)
Description
Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity
Time Frame
Baseline, Week 9, Month 6
Secondary Outcome Measure Information:
Title
Improved mobility as measured by gait speed
Description
Measures related to overall health and mobility
Time Frame
Baseline, Week 9, Month 6
Title
Improved mobility as measured by 6 Minute Walk Test
Description
Measures related to mobility
Time Frame
Baseline, Week 9, Month 6
Title
Improved mobility as measured by Time Up and Go
Description
Measures related to mobility
Time Frame
Baseline, Week 9, Month 6
Title
Improved physical function on the Short Physical Performance Battery
Description
Provide an overall assessment of functional status and physical performance
Time Frame
Baseline, Week 9, Month 6
Title
Improved balance as measured by the Berg Balance Scale
Description
The Berg Balance Scale is a valid and reliable 14 item tool to evaluate static and dynamic balance among older adults. Minimum Score 0 to Maximum Score 56. • Score of < 45 indicates individuals may be at greater risk of falling
Time Frame
Baseline, Week 9, Month 6
Title
Monthly self reports of Health Care Utilization
Description
Monthly self-reports of number of falls, number of hospitalizations, and number of emergency room visits
Time Frame
Baseline, Week 9, Month 3, Month 4, Month 5, Month 6
Title
Patient Reported Outcomes Measure Information System (PROMIS) Global Health
Description
assess subjective measures of physical and mental health, pain, and quality of life
Time Frame
Baseline, Week 9, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Receiving services from CJE SeniorLife Pre-frailty or frailty as determined on the SHARE-FI. Able to ambulate at least 10 feet with moderate assistance (<50% physical assistance) or less. Participants will be able to use their assistive device (e.g. cane or walker) during sessions. > 65 years of age Provision of informed consent and clearance for participation as determined by the Exercise and Screening for You (EASY) Exclusion Criteria: Uncontrolled cardiovascular, metabolic, renal, or respiratory disease that limits exercise participation (e.g., previous heart attack within 3 months of enrollment or uncontrolled diabetes) Resting blood pressure > 180/110 mmHg.59
Facility Information:
Facility Name
Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

High Intensity Walking to Reduce Frailty

We'll reach out to this number within 24 hrs