NCT05720507

Brief Summary

This project explores a novel means of health promotion and prevention of age-related physical frailty, which is designed to overcome barriers to access and promote autonomy in managing physical health.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress79%
Apr 2023Feb 2027

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

April 29, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

January 31, 2023

Last Update Submit

February 2, 2026

Conditions

Aging

Keywords

FrailtyPhysical functionStrengthMobilityBalance

Outcome Measures

Primary Outcomes (1)

  • Health Behavior Stages of Change Questionnaire

    Self-reported measure of engagement with preventive care or wellness activities

    through study completion, average of 4-6 months

Secondary Outcomes (1)

  • Healthcare Access and Utilization Questionnaire

    through study completion, average of 4-6 months

Other Outcomes (7)

  • Two-minute walk test (2MWT)

    through study completion, average of 4-6 months

  • Grip Strength

    through study completion, average of 4-6 months

  • Postural Sway

    through study completion, average of 4-6 months

  • +4 more other outcomes

Interventions

Cafe MoveBEHAVIORAL

Participants will be offered the opportunity to choose from a number of physical function assessments and subsequently provided personalized reports of performance results.

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Legally autonomous to consent
  • Lives independently
  • Ability to sit, stand, and walk without the assistance of another person

You may not qualify if:

  • Not legally autonomous to consent
  • Institutionalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Montana

Missoula, Montana, 59812, United States

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Andrew J Kittelson, PhD

CONTACT

406-243-4015andy.kittelson@umontana.edu

Brian J Loyd

CONTACT

406-243-4015

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single cohort double baseline design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

April 29, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)