The Effect of Walking on Frailty

Frailty Clinical Trial

Official title:

The Effect of High Intensity Walking on Frailty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03654807
• Other study ID #: STU00207757
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 26, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: May 31, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• High Intensity Walking
70-80% HRmax
• Casual Speed Walking
Self selected pace

Locations

Country	Name	City	State
United States	Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and four months
Secondary	Improved mobility as measured by gait speed	Measures related to overall health and mobility	Baseline and four months
Secondary	Improved physical function on the Short Physical Performance Battery	Provide an overall assessment of functional status and physical performance	Baseline and four months
Secondary	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	Baseline and four months
Secondary	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.	Baseline and Four Months
Secondary	Improved mobility as measured by Time Up and Go	Measures related to mobility	Baseline and Four Months
Secondary	Improved mobility as measured by 6 Minute Walk Test	Measures related to mobility	Baseline and Four Months
Secondary	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	Baseline and Four Months