- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02433249
Developing a Intervention to Enhance Motivation for Physical Activities Known to Reduce Fall Risk (ReadySteady)
30. oktober 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
103
Fase
- Fase 2
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
70 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
|
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
Andre navne:
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Eksperimentel: 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.
|
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
Andre navne:
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
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Eksperimentel: 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.
|
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
Andre navne:
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.
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Eksperimentel: 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.
|
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
Andre navne:
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
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in self-reported physical activity behavior
Tidsramme: Baseline; 1 week post; 6 months post
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Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
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Baseline; 1 week post; 6 months post
|
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Change in objectively measured physical activity behavior
Tidsramme: Baseline; 1 week post; 6 months post
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Accelerometers built in to Fitbit Ones
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Baseline; 1 week post; 6 months post
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in functional strength and balance
Tidsramme: Baseline; 1 week post; 6 months post
|
Short Physical Performance Battery
|
Baseline; 1 week post; 6 months post
|
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Change in functional strength and balance
Tidsramme: Baseline; 1 week post; 6 months post
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Timed Up and Go
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Baseline; 1 week post; 6 months post
|
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Change in the number of community resources used for physical activity
Tidsramme: Baseline; 1 week post; 6 months post
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Number of community resources identified and used: 2 item survey
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Baseline; 1 week post; 6 months post
|
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Change in social support for fall-reducing physical activities
Tidsramme: Baseline; 1 week post; 6 months post
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Social support for exercise: Survey
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Baseline; 1 week post; 6 months post
|
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Change in readiness
Tidsramme: Baseline; 1 week post; 6 months post
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Index of Readiness
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Baseline; 1 week post; 6 months post
|
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Change in self-regulation
Tidsramme: Baseline; 1 week post; 6 months post
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Index of Self-Regulation
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Baseline; 1 week post; 6 months post
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Change in self-reported lower extremity function
Tidsramme: Baseline; 1 week post; 6 months post
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Neuro-QOL SF v1.0 - LEx Fnct (Mobility)
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Baseline; 1 week post; 6 months post
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Change in self-reported ability to participate in social activities
Tidsramme: Baseline; 1 week post; 6 months post
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PROMIS SF v2.0 - Ability to Participate Social 4a
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Baseline; 1 week post; 6 months post
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Technology acceptability and utility
Tidsramme: 1 week post; 6 months post
|
10 item survey addressing wearable technology's learnability, utility and role in supporting individual motivation
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1 week post; 6 months post
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Siobhan K McMahon, PhD, University of Minnesota
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- McMahon S, Vankipuram M, Hekler EB, Fleury J. Design and evaluation of theory-informed technology to augment a wellness motivation intervention. Transl Behav Med. 2014 Mar;4(1):95-107. doi: 10.1007/s13142-013-0221-4.
- McMahon S, Fleury J. Wellness in older adults: a concept analysis. Nurs Forum. 2012 Jan-Mar;47(1):39-51. doi: 10.1111/j.1744-6198.2011.00254.x.
- Perez A, Fleury J. Wellness motivation theory in practice. Geriatr Nurs. 2009 Mar-Apr;30(2 Suppl):15-20. doi: 10.1016/j.gerinurse.2009.02.006. No abstract available.
- McMahon S, Talley KM, Wyman JF. Older people's perspectives on fall risk and fall prevention programs: a literature review. Int J Older People Nurs. 2011 Dec;6(4):289-98. doi: 10.1111/j.1748-3743.2011.00299.x.
- McMahon SK, Lewis B, Oakes JM, Wyman JF, Guan W, Rothman AJ. Examining Potential Psychosocial Mediators in a Physical Activity Intervention for Older Adults. West J Nurs Res. 2020 Aug;42(8):581-592. doi: 10.1177/0193945919871697. Epub 2019 Aug 30.
- McMahon SK, Lewis B, Oakes JM, Wyman JF, Guan W, Rothman AJ. Assessing the Effects of Interpersonal and Intrapersonal Behavior Change Strategies on Physical Activity in Older Adults: a Factorial Experiment. Ann Behav Med. 2017 Jun;51(3):376-390. doi: 10.1007/s12160-016-9863-z.
- McMahon SK, Lewis B, Oakes M, Guan W, Wyman JF, Rothman AJ. Older Adults' Experiences Using a Commercially Available Monitor to Self-Track Their Physical Activity. JMIR Mhealth Uhealth. 2016 Apr 13;4(2):e35. doi: 10.2196/mhealth.5120.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2014
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
19. februar 2015
Først indsendt, der opfyldte QC-kriterier
28. april 2015
Først opslået (Skøn)
4. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. november 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. oktober 2019
Sidst verificeret
1. oktober 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 1402S47802
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Cairo UniversityTilmelding efter invitation
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IVI BilbaoInstituto Valenciano de Infertilidad, IVI VALENCIAAfsluttet