The Effect of Walking on Frailty
Primary Purpose
Frailty
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Walking
Casual Speed Walking
Sponsored by
About this trial
This is an interventional treatment trial for Frailty
Eligibility Criteria
Inclusion Criteria:
• > 60 years of age with 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.
- Resident of one of the 10 enrolled retirement community locations. Individuals must be > 60 years of age to move into the retirement communities by virtue of the individual community policies.
- 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.
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% HRmax)
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)
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 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
Total daily physical activity
ActivPal Activity Monitors worn for a one week ambulatory monitoring period, data are sampled at 20 Hz in 10 second intervals.
Improved mobility as measured by Time Up and Go
Measures related to mobility
Improved mobility as measured by 6 Minute Walk Test
Measures related to mobility
Improved balance as measured by the Falls Efficacy
Falls Efficacy Scale as this is a widely-used measure among older adults that evaluates the fear of falling and balance confidence, 10-item questionnaire with scores ranging from minimum score 0 to maximum score 100. A total score of greater than 70 indicates that the person has a fear of falling
Full Information
NCT ID
NCT03654807
First Posted
August 21, 2018
Last Updated
February 22, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT03654807
Brief Title
The Effect of Walking on Frailty
Official Title
The Effect of High Intensity Walking on Frailty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)
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 test the effect of walking intensity on both frailty category (i.e., frail, pre-frail, and nonfrail) and frailty score as a continuous outcome on the SHARE-FI (frailty instrument). As well as test the effect of walking intensity on mobility, physical function, balance, and total Physical Activity.
Detailed Description
Frailty impacts up to 60% of older adults and is a leading cause of dependency among older adults. Frail older adults experience physical problems such as balance difficulties, weakness, decreased endurance, and reduced walking speed that increase risk for falls, hospitalizations, institutionalization, and death. Physical activity has multi-system health benefits and is the most recommended frailty management intervention, but guidelines regarding the specific intensity of physical activity remain unclear. High intensity physical activity is an established and safe therapeutic approach in other populations, but it is unclear as to the extent to which high intensity activity can reduce or reverse frailty. This cluster-randomized study will compare a high intensity walking (HIW) intervention to a self-selected, casual speed walking (CSW) intervention implemented within retirement communities for pre-frail and frail older adults. Investigators will randomize 10 retirement communities with 20 participants at each site (200 total participants) to either a 4-month HIW or CSW intervention. All participants will receive 48, individually supervised overground walking sessions occurring within their retirement community. At the beginning and end of the study, investigators will measure participants' frailty, mobility, physical functioning, balance, and total physical activity measured via an ActivPal accelerometer worn for a 1-week observation period to compare which treatment strategy, HIW or CSW, worked better to reduce frailty (aim #1). Investigators will use the SHARE-Frailty Instrument to evaluate frailty as both a categorical (e.g. non-frail, pre-frail, or frail) and a continuous outcome. This approach will allow investigators to determine how participants move between frailty categories as well as within frailty categories in response to intervention. In aim #2, investigators will determine the effect of walking intensity on mobility, physical functioning, balance, and total physical activity. Investigators hypothesize that HIW participants will show decreased frailty and improved mobility, physical functioning, balance, and physical activity at 4 months. Currently, the optimal physical activity guidelines for older adults with frailty are uncertain. Results from this study will provide important knowledge to inform activity guidelines for older adults with frailty and information on a transformative approach to reducing frailty, improving function, and increasing physical activity among a growing segment of the older adults population.
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
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Walking
Arm Type
Experimental
Arm Description
HIW (70-80% HRmax)
Arm Title
Casual Speed Walking
Arm Type
Experimental
Arm Description
Self selected pace
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Walking
Intervention Description
70-80% HRmax
Intervention Type
Behavioral
Intervention Name(s)
Casual Speed Walking
Intervention Description
Self selected pace
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
SHARE-FI which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity
Time Frame
Baseline and four months
Secondary Outcome Measure Information:
Title
Improved mobility as measured by gait speed
Description
Measures related to overall health and mobility
Time Frame
Baseline and four months
Title
Improved physical function on the Short Physical Performance Battery
Description
Provide an overall assessment of functional status and physical performance
Time Frame
Baseline and four months
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 and four months
Title
Total daily physical activity
Description
ActivPal Activity Monitors worn for a one week ambulatory monitoring period, data are sampled at 20 Hz in 10 second intervals.
Time Frame
Baseline and Four Months
Title
Improved mobility as measured by Time Up and Go
Description
Measures related to mobility
Time Frame
Baseline and Four Months
Title
Improved mobility as measured by 6 Minute Walk Test
Description
Measures related to mobility
Time Frame
Baseline and Four Months
Title
Improved balance as measured by the Falls Efficacy
Description
Falls Efficacy Scale as this is a widely-used measure among older adults that evaluates the fear of falling and balance confidence, 10-item questionnaire with scores ranging from minimum score 0 to maximum score 100. A total score of greater than 70 indicates that the person has a fear of falling
Time Frame
Baseline and Four Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• > 60 years of age with 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.
Resident of one of the 10 enrolled retirement community locations. Individuals must be > 60 years of age to move into the retirement communities by virtue of the individual community policies.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Danilovich, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
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
Citations:
PubMed Identifier
34384049
Citation
Davila VS, Conroy DE, Danilovich MK. Factors That Influence Walking Intervention Adherence for Older Adults Living in Retirement Communities. J Aging Phys Act. 2022 Feb 1;30(1):65-72. doi: 10.1123/japa.2020-0279. Epub 2021 Aug 12.
Results Reference
derived
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The Effect of Walking on Frailty
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