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Active for Life Assisted Living Feasibility and Acceptability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386434
Recruitment Status : Withdrawn (Pandemic, researchers no longer have access to residents of assisted living.)
First Posted : May 13, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Janet L. Larson, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Sedentary Behavior Behavioral: Active for Life: Assisted Living Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Active for Life Assisted Living Feasibility and Acceptability Study
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Feasibility: Number of participants screened [ Time Frame: After completion of the 12 week intervention ]
    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.

  2. Feasibility: Number of participants eligible [ Time Frame: After completion of the 12 week intervention ]
    Several measures will be used to describe the feasibility of the intervention. We will calculate how many participants met eligibility criteria for study participation.

  3. Feasibility: Numbers of participants ineligible by each eligibility criterion [ Time Frame: After completion of the 12 week intervention ]
    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.

  4. Feasibility: Number of participants who enroll [ Time Frame: After completion of the 12 week intervention ]
    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.

  5. Feasibility: Length of time for recruitment activities [ Time Frame: After completion of the 12 week intervention ]
    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.

  6. Feasibility: Percentage of activity sessions attended by participants [ Time Frame: After completion of the 12 week intervention ]
    Several measures will be used to describe the feasibility of the intervention. We will calculate the percentage of activity sessions that participants attended.

  7. Feasibility: Participant retention rates [ Time Frame: After completion of the 12 week intervention ]
    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.

  8. Feasibility: Documentation of stated reasons for participant dropout [ Time Frame: After completion of the 12 week intervention ]
    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.

  9. Feasibility: Injuries and adverse events [ Time Frame: After completion of the 12 week intervention ]
    Several measures will be used to describe the feasibility of the intervention. We will summarize any adverse events/injuries that occur during the study.

  10. Feasibility: Rates of missing or unusable data [ Time Frame: After completion of the 12 week intervention ]
    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.

  11. Feasibility: Time required to complete outcome measures [ Time Frame: After completion of the 12 week intervention ]
    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.

  12. Acceptability: Exit interviews [ Time Frame: After completion of the 12 week intervention ]
    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.

  13. Acceptability: Final acceptability scale [ Time Frame: After completion of the 12 week intervention ]
    This scale consists of 13 questions related to participants' overall satisfaction with the intervention and its components. Higher score indicates greater intervention acceptability.


Secondary Outcome Measures :
  1. Time spent in sedentary behavior and physical activity [ Time Frame: 7 days of data are gathered at baseline at after the 12 week intervention. ]
    ActivPAL monitor will measure time spent sitting/lying, standing, and stepping for 7 consecutive days at each measurement.

  2. Self-efficacy for exercise [ Time Frame: Measured at baseline, three weeks, and after 12 week intervention. ]
    Exercise self-efficacy- 9 items. Potential range of scores is 0 to 90. Higher score indicates higher self-efficacy for exercise.

  3. Value of Physical Activity [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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.

  5. PROMIS Physical Functioning [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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.

  6. PROMIS Anxiety [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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.

  7. PROMIS Depression [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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.

  8. PROMIS Fatigue [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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.

  9. PROMIS Pain Interference [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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.

  10. Positive and Negative Social Influences on PA in Older Adults [ Time Frame: Measured at baseline and after 12 week intervention. ]
    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.

  11. Acceptability: Mid-point acceptability scale [ Time Frame: Measured at 6-weeks (mid-point of intervention) ]
    This scale consists of 3 questions related to acceptability of intervention delivery. Higher score indicates greater intervention acceptability.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386434


Locations
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United States, Michigan
University of Michigan School of Nursing
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Janet L Larson, PhD, RN University of Michigan School of Nursing
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Responsible Party: Janet L. Larson, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT04386434    
Other Study ID Numbers: HUM00175558
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janet L. Larson, University of Michigan:
assisted living
physical activity
sedentary behavior
self-efficacy