Clinical trial NCT04386434: Active for Life Assisted Living Feasibility and Acceptability Study
Official title: Active for Life Assisted Living Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sedentary Behavior
Keywords: assisted living
physical activity
sedentary behavior
self-efficacy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study examines the effects of a physical activity and behavioral program, called Active for Life, to promote increased physical activity and reduced sedentary behavior of older adults who live in assisted living. A sedentary lifestyle is very common in this population and if this program is successful it will be used to promote physical activity and improve the health of older adults in assisted living.

Detailed description: Sedentary behavior (SB) is an emerging health risk, especially for older adults, as it is associated with chronic disease, loss of function, and increased disability and frailty. Older adults in assisted living (AL) are less active than their peers living independently. Recent evidence demonstrates there are substantial health benefits from light physical activity (LPA) and the newly published Physical Activity Guidelines for Americans recommends that older adults replace SB with LPA. An intervention to increase LPA and reduce SB has potential to reduce health risks, slow functional decline and frailty, and delay residents' needs for higher-level care such as a nursing home. We propose to test the feasibility and acceptability of a self-efficacy based intervention, "Active for Life," with the goal of increasing PA and decreasing SB of AL residents.

Active for Life is a 12 week intervention. Key components include (a) exercise with functional circuit training (FCT), walking, and stretching, (b) a behavioral component with a structured self-efficacy enhancing intervention that includes self-regulation strategies, and (c) education that addresses principles of exercise, the distinct health benefits of LPA, the negative consequences of too much sedentary time, and strategies for overcoming barriers to physical activity. It is important to test the feasibility and acceptability of the intervention for AL residents because this population will be more frail than previously tested populations. The intervention has been modified to be appropriate for AL residents based on guidance from AL experts and individual interviews conducted with AL residents. We will enroll 27 participants from approximately four AL facilities. Outcomes will be measured at baseline and at conclusion of the intervention. The primary outcomes are feasibility and acceptability of the intervention, but we will also examine preliminary evidence of outcome measures of objectively-measured sedentary behavior and physical activity, self-efficacy for exercise, value of physical activity, self-rated health, physical function, anxiety, depression, pain interference, and fatigue. This study is innovative because there are no well-established evidence-based interventions to promote PA in the AL setting and none that focus on increasing LPA and decreasing SB.

Eligibility criteria: Inclusion Criteria:

* Residing in assisted living facility
* Inactive (performing moderate level activities for less than 30 min./day, 5 day/week or not performing muscle strengthening activities twice/week) or a desire to increase physical activity
* Score of at least 3 on the Mini-Cog cognitive screening

Exclusion Criteria:

* Mobility issues that prevent participation in PA, such as if they rely on a wheelchair or motorized scooter (not excluded if they require an assistive device such as a cane or walker)
* Hospitalization in the previous month
* Skin on the thigh where ActivPAL monitor would be placed is not intact (has lesions, signs of infection, rash, or skin breakdown)

Primary outcomes:
measure: Feasibility: Number of participants screened
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Number of participants eligible
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Numbers of participants ineligible by each eligibility criterion
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Number of participants who enroll
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Length of time for recruitment activities
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Percentage of activity sessions attended by participants
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Participant retention rates
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Documentation of stated reasons for participant dropout
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Injuries and adverse events
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Rates of missing or unusable data
timeFrame: After completion of the 12 week intervention
measure: Feasibility: Time required to complete outcome measures
timeFrame: After completion of the 12 week intervention
measure: Acceptability: Exit interviews
timeFrame: After completion of the 12 week intervention
measure: Acceptability: Final acceptability scale
timeFrame: After completion of the 12 week intervention
Secondary outcomes:
measure: Time spent in sedentary behavior and physical activity
timeFrame: 7 days of data are gathered at baseline at after the 12 week intervention.
measure: Self-efficacy for exercise
timeFrame: Measured at baseline, three weeks, and after 12 week intervention.
measure: Value of Physical Activity
timeFrame: Measured at baseline and after 12 week intervention.
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
timeFrame: Measured at baseline and after 12 week intervention.
measure: PROMIS Physical Functioning
timeFrame: Measured at baseline and after 12 week intervention.
measure: PROMIS Anxiety
timeFrame: Measured at baseline and after 12 week intervention.
measure: PROMIS Depression
timeFrame: Measured at baseline and after 12 week intervention.
measure: PROMIS Fatigue
timeFrame: Measured at baseline and after 12 week intervention.
measure: PROMIS Pain Interference
timeFrame: Measured at baseline and after 12 week intervention.
measure: Positive and Negative Social Influences on PA in Older Adults
timeFrame: Measured at baseline and after 12 week intervention.
measure: Acceptability: Mid-point acceptability scale
timeFrame: Measured at 6-weeks (mid-point of intervention)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Nursing
state: Michigan
Study officials:
affiliation: University of Michigan School of Nursing
name: Janet L Larson, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: