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Developing a Intervention to Enhance Motivation for Physical Activities Known to Reduce Fall Risk (ReadySteady)

30 oktober 2019 bijgewerkt door: University of Minnesota

Enhancing Motivation for Physical Activity to Reduce the Risk of Falls Among Community-Dwelling Older Adults: A Wellness Intervention.

The purpose of this pilot study is to develop an intervention, based on empirical evidence and health-related behavioral change theory, to enhance motivation for engaging in fall-reducing physical activities.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The intervention being developed, Ready~Steady, combines 3 components; a) interpersonal motivation, b) intrapersonal motivation, and c) physical activity. Theoretical concepts from the wellness motivation theory are (a) translated into intervention strategies; and (b) operationalized as variables to form a basis for evaluating this intervention. The overall objective is to advance the development of Ready~Steady by assessing the impact of its motivation components.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

103

Fase

  • Fase 2

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

70 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • ≥ 70 years, level of physical activity (strength training and aerobic) below national recommendations

Exclusion Criteria:

  • Dementia, recent injury or surgery, unable to participate in light-moderately intense exercise

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: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 1 Physical Activity
Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. All participant receive Fitbit Ones and are asked to use them on a daily basis.
Gedragsmatig: 1 Physical Activity
Fall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use
Andere namen:
  • Otago
Experimenteel: 2 Interpersonal Motivation
Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the interpersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions.
Gedragsmatig: 1 Physical Activity
Fall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use
Andere namen:
  • Otago
Gedragsmatig: Interpersonal Motivation
Strategies used to support Interpersonal motivational targets include: a) discuss and model ways to provide and receive more support for physical activity, b) identify environmental barriers to being physically active, c) problem-solve environmental and social barriers to being physically active, d) use and create new resources that support physical activity behavior
Experimenteel: 3.Intrapersonal Motivation
Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the intrapersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions.
Gedragsmatig: 1 Physical Activity
Fall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use
Andere namen:
  • Otago
Gedragsmatig: Intrapersonal Motivation
Strategies used to support intrapersonal motivation included a) use of the goal attainment scale, b) facilitating the formation of action plans, c) identify and problem solve personal barriers to being active, d) identify satisfying aspects of being active, e) self-evaluate physical activity patterns and progress.
Experimenteel: 4.Full Intervention
Small groups (4-7 people) meeting in community centers weekly for 90 minutes, over the course of 8 weeks. Curricula for meetings are manualized and include introducing and practicing Otago exercises, progressed according to individual capacity and preference, as well as falls prevention. The interventionist also facilitates discussions addressing the intrapersonal and interpersonal motivational intervention content. All participant receive Fitbit Ones and are asked to use them on a daily basis: Fitbit Ones are included in weekly discussions.
Gedragsmatig: 1 Physical Activity
Fall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use
Andere namen:
  • Otago
Gedragsmatig: Interpersonal Motivation
Strategies used to support Interpersonal motivational targets include: a) discuss and model ways to provide and receive more support for physical activity, b) identify environmental barriers to being physically active, c) problem-solve environmental and social barriers to being physically active, d) use and create new resources that support physical activity behavior
Gedragsmatig: Intrapersonal Motivation
Strategies used to support intrapersonal motivation included a) use of the goal attainment scale, b) facilitating the formation of action plans, c) identify and problem solve personal barriers to being active, d) identify satisfying aspects of being active, e) self-evaluate physical activity patterns and progress.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in self-reported physical activity behavior
Tijdsspanne: Baseline; 1 week post; 6 months post
Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
Baseline; 1 week post; 6 months post
Change in objectively measured physical activity behavior
Tijdsspanne: Baseline; 1 week post; 6 months post
Accelerometers built in to Fitbit Ones
Baseline; 1 week post; 6 months post

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in functional strength and balance
Tijdsspanne: Baseline; 1 week post; 6 months post
Short Physical Performance Battery
Baseline; 1 week post; 6 months post
Change in functional strength and balance
Tijdsspanne: Baseline; 1 week post; 6 months post
Timed Up and Go
Baseline; 1 week post; 6 months post
Change in the number of community resources used for physical activity
Tijdsspanne: Baseline; 1 week post; 6 months post
Number of community resources identified and used: 2 item survey
Baseline; 1 week post; 6 months post
Change in social support for fall-reducing physical activities
Tijdsspanne: Baseline; 1 week post; 6 months post
Social support for exercise: Survey
Baseline; 1 week post; 6 months post
Change in readiness
Tijdsspanne: Baseline; 1 week post; 6 months post
Index of Readiness
Baseline; 1 week post; 6 months post
Change in self-regulation
Tijdsspanne: Baseline; 1 week post; 6 months post
Index of Self-Regulation
Baseline; 1 week post; 6 months post
Change in self-reported lower extremity function
Tijdsspanne: Baseline; 1 week post; 6 months post
Neuro-QOL SF v1.0 - LEx Fnct (Mobility)
Baseline; 1 week post; 6 months post
Change in self-reported ability to participate in social activities
Tijdsspanne: Baseline; 1 week post; 6 months post
PROMIS SF v2.0 - Ability to Participate Social 4a
Baseline; 1 week post; 6 months post

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Technology acceptability and utility
Tijdsspanne: 1 week post; 6 months post
10 item survey addressing wearable technology's learnability, utility and role in supporting individual motivation
1 week post; 6 months post

Medewerkers en onderzoekers

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

Sponsor

University of Minnesota

Onderzoekers

  • Hoofdonderzoeker: Siobhan K McMahon, PhD, University of Minnesota

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

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

1 april 2014

Primaire voltooiing (Werkelijk)

1 juni 2015

Studie voltooiing (Werkelijk)

1 juni 2015

Studieregistratiedata

Eerst ingediend

19 februari 2015

Eerst ingediend dat voldeed aan de QC-criteria

28 april 2015

Eerst geplaatst (Schatting)

4 mei 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 november 2019

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2019

Laatst geverifieerd

1 oktober 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 1402S47802

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 .

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