Active for Life Assisted Living Feasibility and Acceptability Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Sedentary Behavior
• Intervention / Treatment: Behavioral: Active for Life: 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Active for Life; The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.

Behavioral: Active for Life: Assisted Living; Each intervention session will take place within the assisted living facility twice a week for 12 weeks. Sessions will begin with 5-10 minutes of walking in the hallway. Participants will be encouraged to walk at their own pace and allowed to take breaks if needed. Next, behavioral strategies based on the construct of self-efficacy from social cognitive theory and education about physical activity will be delivered. This component is scheduled between the walking and circuit training, lasts 15-20 minutes, and serves as a rest period. Circuit training will focus on strength and balance. Approximately 8 exercise stations will be set up, and the exercises performed at each station will be changed approximately every 4 weeks. The circuit training will last ~30-40 minutes, with participants moving from one station to the next at their own pace and taking breaks in between.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Number of participants screened	Several measures will be used to describe the feasibility of the intervention. We will calculate how many participants volunteered to be screened for participation in the study.	After completion of the 12 week intervention
Feasibility: Number of participants eligible	Several measures will be used to describe the feasibility of the intervention. We will calculate how many participants met eligibility criteria for study participation.	After completion of the 12 week intervention
Feasibility: Numbers of participants ineligible by each eligibility criterion	Several measures will be used to describe the feasibility of the intervention. We will summarize reasons that participants were ineligible for study participation by adding up the number of people who don't meet each specific eligibility criterion.	After completion of the 12 week intervention
Feasibility: Number of participants who enroll	Several measures will be used to describe the feasibility of the intervention. We will calculate how many eligible participants decide to enroll in the study.	After completion of the 12 week intervention
Feasibility: Length of time for recruitment activities	Several measures will be used to describe the feasibility of the intervention. We will calculate how much time is spent to recruit the study sample.	After completion of the 12 week intervention
Feasibility: Percentage of activity sessions attended by participants	Several measures will be used to describe the feasibility of the intervention. We will calculate the percentage of activity sessions that participants attended.	After completion of the 12 week intervention
Feasibility: Participant retention rates	Several measures will be used to describe the feasibility of the intervention. We will calculate retention rates of how many participants started and how many completed the study.	After completion of the 12 week intervention
Feasibility: Documentation of stated reasons for participant dropout	Several measures will be used to describe the feasibility of the intervention. We will document stated reasons for dropout from the study as much as we are able.	After completion of the 12 week intervention
Feasibility: Injuries and adverse events	Several measures will be used to describe the feasibility of the intervention. We will summarize any adverse events/injuries that occur during the study.	After completion of the 12 week intervention
Feasibility: Rates of missing or unusable data	Several measures will be used to describe the feasibility of the intervention. We will summarize how much data are missing from baseline, mid-intervention, and post-intervention data collections.	After completion of the 12 week intervention
Feasibility: Time required to complete outcome measures	Several measures will be used to describe the feasibility of the intervention. We will keep record of how long each data collection session takes and calculate average length of data collection at both baseline and post-intervention.	After completion of the 12 week intervention
Acceptability: Exit interviews	Semi-structured exit interviews will ask questions related to acceptability of the intervention, such as how participants felt about the overall intervention and its specific components, whether the time commitment was reasonable, whether assisted living staff were supportive of their participation and goals, and any suggestions for future improvements.	After completion of the 12 week intervention
Acceptability: Final acceptability scale	This scale consists of 13 questions related to participants' overall satisfaction with the intervention and its components. Higher score indicates greater intervention acceptability.	After completion of the 12 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent in sedentary behavior and physical activity	ActivPAL monitor will measure time spent sitting/lying, standing, and stepping for 7 consecutive days at each measurement.	7 days of data are gathered at baseline at after the 12 week intervention.
Self-efficacy for exercise	Exercise self-efficacy- 9 items. Potential range of scores is 0 to 90. Higher score indicates higher self-efficacy for exercise.	Measured at baseline, three weeks, and after 12 week intervention.
Value of Physical Activity	Single item asking "How important is physical activity in your life?" with a Likert response scale ranging from 1 to 5. Higher score will indicate greater importance of physical activity	Measured at baseline and after 12 week intervention.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health	Physical, social, and mental health- 10 items. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low global health and higher scores indicate higher global health.	Measured at baseline and after 12 week intervention.
PROMIS Physical Functioning	Physical function scale- measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low physical function and higher scores indicate higher physical function.	Measured at baseline and after 12 week intervention.
PROMIS Anxiety	General experience with anxious moods- measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low anxiety and higher scores indicate higher anxiety.	Measured at baseline and after 12 week intervention.
PROMIS Depression	General experience with depressed moods- measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low depression and higher scores indicate higher depression.	Measured at baseline and after 12 week intervention.
PROMIS Fatigue	General experience of fatigue- measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low fatigue and higher scores indicate higher fatigue.	Measured at baseline and after 12 week intervention.
PROMIS Pain Interference	Extent to which pain interferes with functioning- measured with computer adaptive testing. Scores are calculated as T-scores with a mean = 50 and standard deviation = 10. Low scores indicate low pain interference and higher scores indicate higher pain interference.	Measured at baseline and after 12 week intervention.
Positive and Negative Social Influences on PA in Older Adults	Support from family and friends for being physically active. The questionnaire has 27 items (15 items describing positive social influence and 12 items describing negative social influence). The potential range of scores for positive social influence is 0 to 180 and the potential range of scores for negative social influence is 0 to 144.	Measured at baseline and after 12 week intervention.
Acceptability: Mid-point acceptability scale	This scale consists of 3 questions related to acceptability of intervention delivery. Higher score indicates greater intervention acceptability.	Measured at 6-weeks (mid-point of intervention)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Janet L Larson, PhD, RN, University of Michigan School of Nursing

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: physical activity; sedentary behavior; self-efficacy; assisted living
• Other Study ID Numbers: HUM00175558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this point the investigators have no plans to share IPD, but would consider a request to share deidentified data if it had the potential to advance science in the promotion of physical activity for older adults

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No