- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02433249
Developing a Intervention to Enhance Motivation for Physical Activities Known to Reduce Fall Risk (ReadySteady)
2019년 10월 30일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
103
단계
- 2 단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
70년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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
다른 이름들:
|
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실험적: 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
다른 이름들:
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
|
|
실험적: 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
다른 이름들:
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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실험적: 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
다른 이름들:
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in self-reported physical activity behavior
기간: Baseline; 1 week post; 6 months post
|
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
기간: Baseline; 1 week post; 6 months post
|
Accelerometers built in to Fitbit Ones
|
Baseline; 1 week post; 6 months post
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in functional strength and balance
기간: 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
기간: Baseline; 1 week post; 6 months post
|
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
기간: Baseline; 1 week post; 6 months post
|
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
기간: Baseline; 1 week post; 6 months post
|
Social support for exercise: Survey
|
Baseline; 1 week post; 6 months post
|
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Change in readiness
기간: Baseline; 1 week post; 6 months post
|
Index of Readiness
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Baseline; 1 week post; 6 months post
|
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Change in self-regulation
기간: Baseline; 1 week post; 6 months post
|
Index of Self-Regulation
|
Baseline; 1 week post; 6 months post
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Change in self-reported lower extremity function
기간: 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
기간: Baseline; 1 week post; 6 months post
|
PROMIS SF v2.0 - Ability to Participate Social 4a
|
Baseline; 1 week post; 6 months post
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Technology acceptability and utility
기간: 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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Siobhan K McMahon, PhD, University of Minnesota
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 4월 1일
기본 완료 (실제)
2015년 6월 1일
연구 완료 (실제)
2015년 6월 1일
연구 등록 날짜
최초 제출
2015년 2월 19일
QC 기준을 충족하는 최초 제출
2015년 4월 28일
처음 게시됨 (추정)
2015년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 11월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 10월 30일
마지막으로 확인됨
2019년 10월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1402S47802
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
1 Physical Activity에 대한 임상 시험
-
The University of Hong Kong모병
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)완전한
-
Foundation University Islamabad모병
-
Karolinska InstitutetEvira AB완전한