Sedentary BehaviorNCT04386434
Active for Life Assisted Living Feasibility and Acceptability Study
A study testing Active for Life: Assisted Living in people with Sedentary Behavior, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Active for Life: Assisted Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Nursing
Ann Arbor, Michigan, 48109
About this 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.
Read the 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.
- Conditions
- Sedentary Behavior
- Being tested
- Active for Life: Assisted Living
- Keywords
- assisted living, physical activity, sedentary behavior, self-efficacy
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active for Life: Assisted LivingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active for Life | Experimental | The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components. Receives: Behavioral: Active for Life: Assisted Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After completion of the 12 week intervention
Secondary outcomes (11)
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.
Measured: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at 6-weeks (mid-point of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Pandemic, researchers no longer have access to residents of assisted living.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet L. Larson, University of Michigan
- Investigators
- Janet L Larson, PhD, RN, Principal investigator, University of Michigan School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386434
- Sponsor's protocol ID
- HUM00175558
- Status last verified
- Aug 2020
- First submitted
- 30 Apr 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active for Life Assisted Living Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT04386434
- Acronym / sponsor ID
- HUM00175558
- Conditions
- Sedentary Behavior
- Keywords
- assisted living, physical activity, sedentary behavior, self-efficacy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Pandemic, researchers no longer have access to residents of assisted living.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active for Life | Experimental | Behavioral: Active for Life: Assisted LivingThe Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active for Life: Assisted LivingEach 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. | Behavioural | Active for Life |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
11 secondary outcomes
Time spent in sedentary behavior and physical activity
Time frame: 7 days of data are gathered at baseline at after the 12 week intervention.
Self-efficacy for exercise
Time frame: Measured at baseline, three weeks, and after 12 week intervention.
Value of Physical Activity
Time frame: Measured at baseline and after 12 week intervention.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Time frame: Measured at baseline and after 12 week intervention.
PROMIS Physical Functioning
Time frame: Measured at baseline and after 12 week intervention.
PROMIS Anxiety
Time frame: Measured at baseline and after 12 week intervention.
PROMIS Depression
Time frame: Measured at baseline and after 12 week intervention.
PROMIS Fatigue
Time frame: Measured at baseline and after 12 week intervention.
PROMIS Pain Interference
Time frame: Measured at baseline and after 12 week intervention.
Positive and Negative Social Influences on PA in Older Adults
Time frame: Measured at baseline and after 12 week intervention.
Acceptability: Mid-point acceptability scale
Time frame: Measured at 6-weeks (mid-point of intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet L Larson, PhD, RN principal investigator
University of Michigan School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active for Life: Assisted Living in people with Sedentary Behavior, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Number of participants screened (time frame: After completion of the 12 week intervention). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.