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Active for Life Assisted Living Feasibility and Acceptability Study

26 sierpnia 2020 zaktualizowane przez: Janet L. Larson, University of Michigan
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.

Przegląd badań

Status

Wycofane

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48109
        • University of Michigan School of Nursing

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

55 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Active for Life
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Feasibility: Number of participants screened
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Number of participants eligible
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Numbers of participants ineligible by each eligibility criterion
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Number of participants who enroll
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Length of time for recruitment activities
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Percentage of activity sessions attended by participants
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Participant retention rates
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Documentation of stated reasons for participant dropout
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Injuries and adverse events
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Rates of missing or unusable data
Ramy czasowe: 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.
After completion of the 12 week intervention
Feasibility: Time required to complete outcome measures
Ramy czasowe: 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.
After completion of the 12 week intervention
Acceptability: Exit interviews
Ramy czasowe: 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.
After completion of the 12 week intervention
Acceptability: Final acceptability scale
Ramy czasowe: 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.
After completion of the 12 week intervention

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Time spent in sedentary behavior and physical activity
Ramy czasowe: 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.
7 days of data are gathered at baseline at after the 12 week intervention.
Self-efficacy for exercise
Ramy czasowe: 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.
Measured at baseline, three weeks, and after 12 week intervention.
Value of Physical Activity
Ramy czasowe: 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
Measured at baseline and after 12 week intervention.
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Ramy czasowe: 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.
Measured at baseline and after 12 week intervention.
PROMIS Physical Functioning
Ramy czasowe: 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.
Measured at baseline and after 12 week intervention.
PROMIS Anxiety
Ramy czasowe: 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.
Measured at baseline and after 12 week intervention.
PROMIS Depression
Ramy czasowe: 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.
Measured at baseline and after 12 week intervention.
PROMIS Fatigue
Ramy czasowe: 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.
Measured at baseline and after 12 week intervention.
PROMIS Pain Interference
Ramy czasowe: 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.
Measured at baseline and after 12 week intervention.
Positive and Negative Social Influences on PA in Older Adults
Ramy czasowe: 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.
Measured at baseline and after 12 week intervention.
Acceptability: Mid-point acceptability scale
Ramy czasowe: 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.
Measured at 6-weeks (mid-point of intervention)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Michigan

Śledczy

  • Główny śledczy: Janet L Larson, PhD, RN, University of Michigan School of Nursing

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 maja 2020

Zakończenie podstawowe (Oczekiwany)

1 grudnia 2020

Ukończenie studiów (Oczekiwany)

1 grudnia 2020

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 maja 2020

Pierwszy wysłany (Rzeczywisty)

13 maja 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 sierpnia 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 sierpnia 2020

Ostatnia weryfikacja

1 sierpnia 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • HUM00175558

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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