Clinical trial NCT05720507: Preliminary Testing of Cafe Move for Primary Prevention of Physical Frailty
Official title: Cafe Move: A Novel Program for Prevention of Age-Related Physical Frailty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Keywords: Frailty
Physical function
Strength
Mobility
Balance
Lead sponsor: University of Montana
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single cohort double baseline design
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Behavior Stages of Change Questionnaire
timeFrame: through study completion, average of 4-6 months
Secondary outcomes:
measure: Healthcare Access and Utilization Questionnaire
timeFrame: through study completion, average of 4-6 months
Other outcomes:
measure: Two-minute walk test (2MWT)
timeFrame: through study completion, average of 4-6 months
measure: Grip Strength
timeFrame: through study completion, average of 4-6 months
measure: Postural Sway
timeFrame: through study completion, average of 4-6 months
measure: Activities-Specific Balance Confidence Scale
timeFrame: through study completion, average of 4-6 months
measure: Lifespace Mobility Questionnaire
timeFrame: through study completion, average of 4-6 months
measure: Role Participation Questionnaire
timeFrame: through study completion, average of 4-6 months
measure: Physical Function Questionnaire
timeFrame: through study completion, average of 4-6 months
Locations:
city: Missoula
country: United States
facility: University of Montana
state: Montana
Study officials:
References: