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임상시험 NCT05130203 (MouvMat)은(는) 신체 비활동, 인지 저하, 노화, 사회적 고립에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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토론토 대학교Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes (MouvMat)
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임상시험 NCT05130203 (MouvMat)은(는) 신체 비활동, 인지 저하, 노화, 사회적 고립에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2022년 10월 1일에 시작되어 60명의 참여자를 모집하고 있습니다. 토론토 대학교이(가) 진행하며, 2025년 1월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 6월 13일에 갱신되었습니다.
간단한 개요
Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs. Physical activity is an accepted intervention to improve the physical health, cognition, and well-being of older adults. Moreover, systematic reviews have found that exergaming (i.e. physical activity gamified with technology) offers physical, cognitive, and social benefits by means of dual-task activities that engage both motor and cognitive abilities. The effect of exergaming for older adults in LTC is less clear, as this population has greater health needs related to physical health conditions, cognitive impairment, and functional dependence. Given the increased global demand for LTC, there is a need to develop and assess innovative exergaming technologies that can support the physical and cognitive health of LTC residents.
MouvMat is an exergaming technology intervention with an interactive digital gaming surface designed for older adults (OA) in LTC settings. Participants can play familiar games, like Simon or Bingo, by stepping on or tapping the surface with an assistive pointing device. Games can be played individually or with multiple players. LED lights on the surface provide an adaptive digital display and embedded pressure sensors respond to players' input. The investigators collaboratively designed a preliminary prototype with OA aged 65 and older in a pilot project.
The overall objective of this proposal is to conduct a pilot RCT of the Mouvmat to evaluate the feasibility, acceptability and efficacy of the exergaming technology to improve the primary outcome of mobility, and the secondary outcomes of cognitive function and social isolation compared to a usual care control group receiving standard recreational programming by recreational therapists.
상세한 설명
The sample size calculation was completed based on an effect size of 0.65 (power = 0.80; 2-tailed; α= 0.05). Assuming a 5% attrition rate, a total of 56 residents (28 people in a control group and 28 people in the intervention group) will be recruited. A block randomization design using a number generator to conceal the randomization sequence will be used to assign participants' units to the intervention or control groups. Block randomization was conducted to comply with COVID-19 restrictions. The investigators will attempt to recruit equal numbers of men and women with a range of mobility requirements (i.e., ambulate independently, using gait aids such as canes or walkers). In addition, a mix of approximately 5-10 LTC staff and/or residents' family members will be recruited at the end of the trial to conduct semi-structured interviews to understand the acceptability of the technology, design, usability and enjoyment, potential facilitators and barriers to exergame technology.
공식 제목
Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes With a User-centered Design Approach
질환/상태
신체 비활동인지 저하노화사회적 고립출판물
이 임상 시험에 대해 발표된 과학 논문 및 연구 자료.- Ikezoe T, Asakawa Y, Shima H, Kishibuchi K, Ichihashi N. Daytime physical activity patterns and physical fitness in institutionalized elderly women: an exploratory study. Arch Gerontol Geriatr. 2013 Sep-Oct;57(2):221-5. doi: 10.1016/j.archger.2013.04.004. Epub 2013 May 9.
- Chu CH, Puts M, Brooks D, Parry M, McGilton KS. A Feasibility Study of a Multifaceted Walking Intervention to Maintain the Functional Mobility, Activities of Daily Living, and Quality of Life of Nursing Home Residents With Dementia. Rehabil Nurs. 2020 Jul/Aug;45(4):204-217. doi: 10.1097/rnj.0000000000000186.
- Shankar A, McMunn A, Demakakos P, Hamer M, Steptoe A. Social isolation and loneliness: Prospective associations with functional status in older adults. Health Psychol. 2017 Feb;36(2):179-187. doi: 10.1037/hea0000437. Epub 2016 Oct 27.
- de Souto Barreto P, Morley JE, Chodzko-Zajko W, H Pitkala K, Weening-Djiksterhuis E, Rodriguez-Manas L, Barbagallo M, Rosendahl E, Sinclair A, Landi F, Izquierdo M, Vellas B, Rolland Y; International Association of Gerontology and Geriatrics - Global Aging Research Network (IAGG-GARN) and the IAGG European Region Clinical Section. Recommendations on Physical Activity and Exercise for Older Adults Living in Long-Term Care Facilities: A Taskforce Report. J Am Med Dir Assoc. 2016 May 1;17(5):381-92. doi: 10.1016/j.jamda.2016.01.021. Epub 2016 Mar 21.
- Beard JR, Officer A, de Carvalho IA, Sadana R, Pot AM, Michel JP, Lloyd-Sherlock P, Epping-Jordan JE, Peeters GMEEG, Mahanani WR, Thiyagarajan JA, Chatterji S. The World report on ageing and health: a policy framework for healthy ageing. Lancet. 2016 May 21;387(10033):2145-2154. doi: 10.1016/S0140-6736(15)00516-4. Epub 2015 Oct 29.
- Chu CH, Biss RK, Cooper L, Quan AML, Matulis H. Exergaming Platform for Older Adults Residing in Long-Term Care Homes: User-Centered Design, Development, and Usability Study. JMIR Serious Games. 2021 Mar 9;9(1):e22370. doi: 10.2196/22370.
기타 연구 식별자
- MouvMat
- 00693
NCT 번호
실제 연구 시작일
2022-10-01
최신 업데이트 게시
2024-06-13
예상 연구 완료일
2025-01
계획된 등록 인원
60
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
nursing homes
long-term care
exergaming
user-centered design
older adult
aging
depression
dementia
long-term care
exergaming
user-centered design
older adult
aging
depression
dementia
주요 목적
지지요법
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적MouvMat Exergaming Older adults in the intervention group will participate in a 6-week, 3 times per week, 45 minutes per session exercise program involving use of the MouvMat. Each resident from the intervention group will engage with the exergame supervised by a qualified and trained RA. Each intervention session will involve groups of 4-5 participants, with participants taking turns. An RA blinded to participants' condition will collect the outcome data. | Mouvmat Exergaming Sessions engaging with exergaming device. |
기타Standard Recreational Programming A control group will meet on a similar schedule as the MouvMat group for standard recreational programming conducted by onsite recreational therapists. The same RA from the experimental group will collect outcome measurements from control group participants. | Standard Recreational Programming Conducted by recreational therapists. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in mean mobility scores on the Timed-up-and-Go test | Completion time in seconds when participant sits in a standard armchair and is instructed to stand up and walk to a line 3 m away at their normal pace, turn around and sit back down in the chair. | Baseline and mid-point of the intervention (3 weeks) |
Change in mean mobility scores on the Timed-up-and-Go test | Completion time in seconds when participant sits in a standard armchair and is instructed to stand up and walk to a line 3 m away at their normal pace, turn around and sit back down in the chair. | Baseline and following the completion of the intervention (6 weeks) |
Change in mean mobility scores on the 2-Minute Walk Test | Distance walked in meters when a participant is instructed to walk at the fastest speed that they can for 2 minutes. | Baseline and mid-point of the intervention (3 weeks) |
Change in mean mobility scores on the 2-Minute Walk Test | Distance walked in meters when a participant is instructed to walk at the fastest speed that they can for 2 minutes. | Baseline and following the completion of the intervention (6 weeks) |
Adverse events (e.g. injury) related to exergame use | Number of adverse events related to use of the exergame in the intervention group | Over the course of the intervention (baseline to 6 weeks) |
Feasibility related to adherence rate | Mean percentage of sessions attended in the intervention group (i.e., number of sessions attended / total scheduled sessions) | Over the course of the intervention (baseline to 6 weeks) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in mean working memory scores on digit span | Total scores for the WAIS-III forward and backward digit span, in which participants are asked to repeat a series of digits that are read by an experimenter in the same order (forward) or reverse order (backward). | Baseline and mid-point of the intervention (3 weeks) |
Change in mean working memory scores on digit span | Total scores for the WAIS-III forward and backward digit span, in which participants are asked to repeat a series of digits that are read by an experimenter in the same order (forward) or reverse order (backward). | Baseline and following the completion of the intervention (6 weeks) |
Change in mean basic attention/psychomotor speed on the Trail Making Test A | Time to completion in seconds on a task requiring connecting numbered dots on a page in order as quickly as possible. | Baseline and mid-point of the intervention (3 weeks) |
Change in mean basic attention/psychomotor speed on the Trail Making Test A | Time to completion in seconds on a task requiring connecting numbered dots on a page in order as quickly as possible. | Baseline and following the completion of the intervention (6 weeks) |
Change in mean alternating attention scores on the Trail Making Test B | Time to completion in seconds on a task requiring switching between connecting numbers and letters in dots on a page as quickly as possible. | Baseline and mid-point of the intervention (3 weeks) |
Change in mean alternating attention scores on the Trail Making Test B | Time to completion in seconds on a task requiring switching between connecting numbers and letters in dots on a page as quickly as possible. | Baseline and following the completion of the intervention (6 weeks) |
Change in errors made on an alternating sequences test | Number of errors made on a task requiring alternating between drawing two designs. This test is sensitive to cognitive problems with executive functions including inhibition and perseveration. | Baseline and mid-point of the intervention (3 weeks) |
Change in errors made on an alternating sequences test | Number of errors made on a task requiring alternating between drawing two designs. This test is sensitive to cognitive problems with executive functions including inhibition and perseveration. | Baseline and following the completion of the intervention (6 weeks) |
Change in mean verbal fluency scores | Number of words generated in one minute given a letter cue | Baseline and mid-point of the intervention (3 weeks) |
Change in mean verbal fluency scores | Number of words generated in one minute given a letter cue | Baseline and following the completion of the intervention (6 weeks) |
Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3 | Total score on a 20-item questionnaire that assesses how often a person feels lonely and isolated from others. | Baseline and mid-point of the intervention (3 weeks) |
Change in mean scores for social isolation assessed by UCLA Loneliness Scale 3 | Total score on a 20-item questionnaire that assesses how often a person feels lonely and isolated from others. | Baseline and following the completion of the intervention (6 weeks) |
Change in mean scores on the Cornell Scale for Depression in Dementia | Total scores on a measure based on interviews on 19 items related to depression. | Baseline and mid-point of the intervention (3 weeks) |
Change in mean scores on the Cornell Scale for Depression in Dementia | Total scores on a measure based on interviews on 19 items related to depression. | Baseline and following the completion of the intervention (6 weeks) |
적격성 기준
연령대
성인, 노인
최소 연령
55 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- All residents at the participating long-term care homes are eligible if they are 55 years of age or older
- Ability to communicate and speak English
- Able to provide informed consent or have a substitute decision maker (SDM) who provides informed consent
- A family member, friend, or personally-hired caregiver of an older adult residing in one of our participating LTC facilities are eligible to participate if they are 18 years of age or older, can communicate and speak English
- The LTC resident does not need to be enrolled in or study in order for their family member/friend/caregiver to participate
- LTC staff are eligible if they can communicate and speak English, are currently working in one of the participating LTC facilities, have at least 6 months experience working with older adults in LTC, providing or supervising physical or recreational activities, or involved with purchasing or directing these activities, and are a member of one of the following professions/positions: physiotherapist, physiotherapy assistant, recreational therapist, or LTC administrator.
- Residents will be ineligible to participate in the study is they cannot communicate or speak English
- Residents who typically do not participate in recreational activities
- Residents who have a severe sensory (e.g., deaf, blind) or severe to moderate cognitive impairment AND/OR scores less than 20 on the Mini- Mental Status Examination (MMSE)
- Family Members who cannot communicate or speak English
- Family Members who cannot interact with the MouvMat due to sensory limitations (i.e., severe visual or auditory impairment)
- Family Members who cannot provide verbal feedback
토론토 대학교232개의 진행 중인 임상시험 탐색 가능Social Sciences and Humanities Research Council of Canada연구 책임자
Charlene Chu, 책임연구자, Assistant Professor, University of Toronto
연구 대표 연락처
연락처: Charlene Chu, PhD, 416-946-0217, [email protected]
연락처: Shefali Ram, 416-946-8304, [email protected]
2 1개국에 임상시험 장소
Chester Village, Toronto, Canada
완료
Kensington Gardens, Toronto, Canada
Charlene, 연락처
모집중