Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Active for Life Assisted Living Feasibility and Acceptability Study

26 augustus 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • University of Michigan School of Nursing

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

55 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Active for Life
The Active Life intervention includes structured walking, functional circuit training, stretching and behavior/educational components.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility: Number of participants screened
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time spent in sedentary behavior and physical activity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 mei 2020

Primaire voltooiing (Verwacht)

1 december 2020

Studie voltooiing (Verwacht)

1 december 2020

Studieregistratiedata

Eerst ingediend

30 april 2020

Eerst ingediend dat voldeed aan de QC-criteria

8 mei 2020

Eerst geplaatst (Werkelijk)

13 mei 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2020

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2020

Laatst geverifieerd

1 augustus 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • HUM00175558

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren