Active for Life Assisted Living Feasibility and Acceptability Study
調査の概要
詳細な説明
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.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan School of Nursing
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Active for Life
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Feasibility: Number of participants screened
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Feasibility: Number of participants eligible
時間枠：After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate how many participants met eligibility criteria for study participation.
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After completion of the 12 week intervention
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Feasibility: Numbers of participants ineligible by each eligibility criterion
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Feasibility: Number of participants who enroll
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Feasibility: Length of time for recruitment activities
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Feasibility: Percentage of activity sessions attended by participants
時間枠：After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will calculate the percentage of activity sessions that participants attended.
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After completion of the 12 week intervention
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Feasibility: Participant retention rates
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Feasibility: Documentation of stated reasons for participant dropout
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Feasibility: Injuries and adverse events
時間枠：After completion of the 12 week intervention
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Several measures will be used to describe the feasibility of the intervention.
We will summarize any adverse events/injuries that occur during the study.
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After completion of the 12 week intervention
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Feasibility: Rates of missing or unusable data
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Feasibility: Time required to complete outcome measures
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Acceptability: Exit interviews
時間枠：After completion of the 12 week intervention
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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.
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After completion of the 12 week intervention
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Acceptability: Final acceptability scale
時間枠：After completion of the 12 week intervention
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This scale consists of 13 questions related to participants' overall satisfaction with the intervention and its components.
Higher score indicates greater intervention acceptability.
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After completion of the 12 week intervention
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time spent in sedentary behavior and physical activity
時間枠：7 days of data are gathered at baseline at after the 12 week intervention.
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ActivPAL monitor will measure time spent sitting/lying, standing, and stepping for 7 consecutive days at each measurement.
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7 days of data are gathered at baseline at after the 12 week intervention.
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Self-efficacy for exercise
時間枠：Measured at baseline, three weeks, and after 12 week intervention.
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Exercise self-efficacy- 9 items.
Potential range of scores is 0 to 90.
Higher score indicates higher self-efficacy for exercise.
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Measured at baseline, three weeks, and after 12 week intervention.
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Value of Physical Activity
時間枠：Measured at baseline and after 12 week intervention.
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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
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Measured at baseline and after 12 week intervention.
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Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
時間枠：Measured at baseline and after 12 week intervention.
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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.
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Measured at baseline and after 12 week intervention.
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PROMIS Physical Functioning
時間枠：Measured at baseline and after 12 week intervention.
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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.
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Measured at baseline and after 12 week intervention.
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PROMIS Anxiety
時間枠：Measured at baseline and after 12 week intervention.
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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.
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Measured at baseline and after 12 week intervention.
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PROMIS Depression
時間枠：Measured at baseline and after 12 week intervention.
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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.
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Measured at baseline and after 12 week intervention.
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PROMIS Fatigue
時間枠：Measured at baseline and after 12 week intervention.
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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.
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Measured at baseline and after 12 week intervention.
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PROMIS Pain Interference
時間枠：Measured at baseline and after 12 week intervention.
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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.
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Measured at baseline and after 12 week intervention.
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Positive and Negative Social Influences on PA in Older Adults
時間枠：Measured at baseline and after 12 week intervention.
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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.
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Measured at baseline and after 12 week intervention.
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Acceptability: Mid-point acceptability scale
時間枠：Measured at 6-weeks (mid-point of intervention)
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This scale consists of 3 questions related to acceptability of intervention delivery.
Higher score indicates greater intervention acceptability.
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Measured at 6-weeks (mid-point of intervention)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Janet L Larson, PhD, RN、University of Michigan School of Nursing
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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