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NCT Number: NCT05720507

Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The purpose of this investigation is to field-test a physical function assessment paradigm, designed to inform people of their physical function relative to peers of similar demographic characteristics (e.g., similar age, sex, height, etc.), to promote recommended preventive health behaviors. The physical function assessment paradigm is known as Cafe Move. Our primary research hypothesis is that people will advance along the stages of behavior change (i.e., more likely to participate in recommended preventive healthcare for physical function), after accessing Cafe Move assessments. This study is a single cohort (n=36 participants), double-baseline design, intended primarily to collect pilot data. The results will inform the design of a larger controlled trial.

This study will examine the safety, feasibility, acceptability, and preliminary efficacy of Café Move. Briefly, we will make Café Move available to at-risk populations (i.e., independent-living older adults) via the following approach. First, during a 3-month control phase, we will monitor participants' health behaviors and engagement with preventive health offerings via periodic phone surveys. We will then make Café Move available and subsequently monitor health behaviors and engagement with preventive health offerings. This design will allow us to examine feasibility of the Café Move intervention, to better understand the reach of the program within and across communities, and to determine variance and covariance for the outcome measures of interest.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not legally autonomous to consent
  • Institutionalized

Treatment and study plan

Cafe Move

Behavioral

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

Primary outcomes

  1. Health Behavior Stages of Change Questionnaire

    Time frame: through study completion, average of 4-6 months

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

Secondary outcomes

  1. Healthcare Access and Utilization Questionnaire

    Time frame: through study completion, average of 4-6 months

    Self-reported measure of healthcare utilization of a number of different services

Other outcomes

  1. Two-minute walk test (2MWT)

    Time frame: through study completion, average of 4-6 months

    Measure of distance walked in 2 minutes along a 50-foot course

  2. Grip Strength

    Time frame: through study completion, average of 4-6 months

    Measure of participants' maximum grip strength using a handheld dynamometer

  3. Postural Sway

    Time frame: through study completion, average of 4-6 months

    Timed test of participants' ability to balance under 4 different conditions

  4. Activities-Specific Balance Confidence Scale

    Time frame: through study completion, average of 4-6 months

    Self-reported questionnaire that assess participants' perceived balance

  5. Lifespace Mobility Questionnaire

    Time frame: through study completion, average of 4-6 months

    Self-reported questionnaire that assess participants' interaction with home and community settings

  6. Role Participation Questionnaire

    Time frame: through study completion, average of 4-6 months

    Self-reported questionnaire that captures various social, demographic, and activity level information from participants

  7. Physical Function Questionnaire

    Time frame: through study completion, average of 4-6 months

    Self-reported questionnaire assessing perceived function with daily activities

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew J Kittelson, PhD

CONTACT

[email protected]

406-243-4015

Brian J Loyd

CONTACT

406-243-4015

Sponsors and collaborators

Lead sponsor

University of Montana

Other

Registry information

Official study title

Cafe Move: A Novel Program for Prevention of Age-Related Physical Frailty

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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