NCT03654807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

4.2 years

First QC Date

August 21, 2018

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Improved mobility as measured by gait speed

    Baseline and four months

  • Improved physical function on the Short Physical Performance Battery

    Baseline and four months

  • Improved balance as measured by the Berg Balance Scale

    Baseline and four months

  • Total daily physical activity

    Baseline and Four Months

  • Improved mobility as measured by Time Up and Go

    Baseline and Four Months

  • +2 more secondary outcomes

Study Arms (2)

High Intensity Walking

EXPERIMENTAL

HIW (70-80% HRmax)

Behavioral: High Intensity Walking

Casual Speed Walking

EXPERIMENTAL

Self selected pace

Behavioral: Casual Speed Walking

Interventions

70-80% HRmax

High Intensity Walking

Self selected pace

Casual Speed Walking

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Univiersity Department of Physical Therapy and Human Movement Sciences

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret Danilovich, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 31, 2018

Study Start

November 26, 2018

Primary Completion

January 31, 2023

Study Completion

May 31, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations