FrailtyNCT03654807

The Effect of Walking on Frailty

A study testing High Intensity Walking and Casual Speed Walking in people with Frailty, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Frailty
What is being tested?: High Intensity Walking and Casual Speed Walking
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 165 participants
Where: 1 siteUnited States
Study dates: 26 Nov 2018to 31 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

• > 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).

Who cannot join

• 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: The Effect of High Intensity Walking on Frailty

Read the 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.

Conditions: Frailty
Being tested: High Intensity Walking, Casual Speed Walking
Medical subject headings: Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Intensity WalkingBehavioural
70-80% HRmax
Casual Speed WalkingBehavioural
Self selected pace

Study groups in NCT03654807
Study group	Role	What they receive
High Intensity Walking	Experimental	HIW (70-80% HRmax) Receives: Behavioral: High Intensity Walking
Casual Speed Walking	Experimental	Self selected pace Receives: Behavioral: Casual Speed Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)
Survey of Health Among Retired Europeans - Frailty Index (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity.
There is not a max and min score; Higher scores indicate greater severity of frailty.
Classification for Women:
Non-frail: ≤0.315 Pre-frail: 0.316-2.130 Frail: ≥2.131 Classification for Men" Non-frail: ≤1.210 Pre-frail: 1.211-3.005 Frail: ≥3.006
Measured: Baseline and four months

Secondary outcomes (7)

Improved Mobility as Measured by Gait Speed
Gait speed was measured independently as a continuous measure in meters per second (m/s). Participants completed two trials over 10 meters at both self-selected usual speed ("walk at your normal comfortable pace") and fastest-possible speed ("as fast as you safely can"), and the two trials were averaged for analysis.
Measured: Baseline and four months
Improved Physical Function on the Short Physical Performance Battery
The Short Physical Performance Battery is a scale to assess overall functional status and physical performance Min score = 0 Max score = 12 Higher scores = better physical function
Measured: Baseline and four months
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
Measured: Baseline and four months
Total Daily Physical Activity
ActivPal Activity Monitors worn for a one week ambulatory monitoring period, counting number of steps
Measured: Baseline and Four Months
Time Up and Go
Measures the time the participant takes to rise from a chair, walk 10 feet, turn around, walk back to the chair, and sit down
Measured: Baseline and Four Months
6 Minute Walk Test
Distance walked in 6 minutes in meters
Measured: Baseline and Four Months
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
Measured: Baseline and Four Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 201831 May 2024

First posted31 Aug 2018
Study start26 Nov 2018
Primary completion31 Jan 2023
Study completion31 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for FrailtyStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03654807
Sponsor's protocol ID: STU00207757
Status last verified: Oct 2024
First submitted: 21 Aug 2018
Last updated: 2 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Danilovich M, Rubin DS, Conroy DE, Diaz L, Cheung Y, Corcos D, Bonner LB. A high intensity vs. casual speed walking intervention to reverse frailty among older adults: a cluster randomized controlled trial. PLoS One. 2026 Sep 30;21(9):e0357605. doi: 10.1371/journal.pone.0357605. eCollection 2026.
PubMed 42814673
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.
PubMed 34384049

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of High Intensity Walking on Frailty
ClinicalTrials.gov ID: NCT03654807
Acronym / sponsor ID: STU00207757
Conditions: Frailty
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 26 Nov 2018 (actual)
Primary completion: 31 Jan 2023 (actual)
Study completion: 31 May 2024 (actual)
First posted: 31 Aug 2018 (actual)
Results: Posted 2 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
High Intensity Walking	Experimental	Behavioral: High Intensity WalkingHIW (70-80% HRmax)
Casual Speed Walking	Experimental	Behavioral: Casual Speed WalkingSelf selected pace

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

• > 60 years of age with pre-frailty or frailty as determined on the SHARE-FI.

Key exclusion criteria (2 listed)

• Uncontrolled cardiovascular, metabolic, renal, or respiratory disease that limits exercise participation (e.g., previous heart attack within 3 months of enrollment or uncontrolled diabetes)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Intensity Walking70-80% HRmax	Behavioural	High Intensity Walking
Casual Speed WalkingSelf selected pace	Behavioural	Casual Speed Walking

Primary outcome

Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)
Time frame: Baseline and four months
Survey of Health Among Retired Europeans - Frailty Index (SHARE-FI) which assesses fatigue, appetite, weakness, walking difficulties, and low physical activity. There is not a max and min score; Higher scores indicate greater severity of frailty. Classification for Women: Non-frail: ≤0.315 Pre-frail: 0.316-2.130 Frail: ≥2.131 Classification for Men" Non-frail: ≤1.210 Pre-frail: 1.211-3.005 Frail: ≥3.006

7 secondary outcomes

Improved Mobility as Measured by Gait Speed
Time frame: Baseline and four months
Improved Physical Function on the Short Physical Performance Battery
Time frame: Baseline and four months
Improved Balance as Measured by the Berg Balance Scale
Time frame: Baseline and four months
Total Daily Physical Activity
Time frame: Baseline and Four Months
Time Up and Go
Time frame: Baseline and Four Months
6 Minute Walk Test
Time frame: Baseline and Four Months
Improved Balance as Measured by the Falls Efficacy
Time frame: Baseline and Four Months

Results and safety

Results posted to the registry on 2 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Intensity Walking	81	47
Casual Speed Walking	84	58

Primary outcome: Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI)

Time frame: Baseline and four months. Mean (Standard Deviation). Unit: score on a scale

Measure	High Intensity Walking n = 47	Casual Speed Walking n = 58
Baseline	2.10 (1.10)	2.35 (1.20)
Four months	0.61 (1.29)	1.20 (1.47)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the course of the 4 month intervention that each participant was enrolled in the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Intensity Walking	4 of 81 (4.9%)	7 of 81 (8.6%)	0 of 81
Casual Speed Walking	9 of 84 (10.7%)	2 of 84 (2.4%)	0 of 84

Limitations and caveats (from the sponsor): Although enrollment mirrored the demographics of senior living residents, 75% of our participants were white. Thus, the generalizability of our findings to other ethnic groups and diverse populations needs to be established in future studies. We acknowledge a large drop-out rate from enrollment to analysis (36%). Attrition is a widespread challenge in exercise programs and an estimated 50% of participants drop

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42814673Danilovich M, Rubin DS, Conroy DE, Diaz L, Cheung Y, Corcos D, Bonner LB. A high intensity vs. casual speed walking intervention to reverse frailty among older adults: a cluster randomized controlled trial. PLoS One. 2026 Sep 30;21(9):e0357605. doi: 10.1371/journal.pone.0357605. eCollection 2026.
Derived from this study: PubMed 34384049Davila 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaret Danilovich, PhD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Walking and Casual Speed Walking in people with Frailty, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survey of Health, Ageing, and Retirement in Europe-Frailty Instrument (SHARE-FI) (time frame: Baseline and four months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03654807, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.