Active for Life Assisted Living Feasibility and Acceptability Study

Sedentary Behavior Clinical Trial

Official title:

Active for Life Assisted Living Feasibility and Acceptability Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04386434
• Other study ID #: HUM00175558
• Status: Withdrawn
• Phase: N/A
• Start date: May 2020
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sedentary Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan School of Nursing	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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)