Dementia Moves: Protocol for a Feasibility Study

NCT ID: NCT06400108

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-05-31

Brief Summary

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Most long-term care (LTC) residents live with frailty and dementia and the proportion with more advanced cognitive impairment is increasing. Residents with dementia often have limited functional ability to complete their activities of daily living (ADLs) and are vulnerable to further functional decline. Multicomponent exercise can help prevent functional decline, but residents with dementia are less likely to receive it and have not often been included in previous intervention studies. The Dementia Moves intervention was designed to fill this gap. It is an individually tailored multicomponent group exercise program with an aerobic warm-up and a focus on moderate to high intensity functional balance and strength training. This pilot feasibility study will examine the feasibility of delivering Dementia Moves with 16 LTC residents across 2 homes in Nova Scotia (primary outcomes: recruitment, retention, adherence, acceptability, barriers/facilitators to delivery, fidelity; secondary outcomes: ADLs, adverse events). The next step will be to conduct a larger trial to determine the effect of the intervention on ADLs.

Through a parallel cluster randomized controlled trial, investigators will measure the effect of the Dementia Moves program on ADLs and adverse events (i.e., falls, fractures, hospitalizations, emergency department visits) for LTC residents with moderate to severe dementia (i.e., Mini-Mental State Exam of 20 or less).

Detailed Description

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Background: Most long-term care (LTC) residents live with dementia and the proportion with more advanced cognitive impairment is increasing. Residents with dementia often have limited functional ability to complete their activities of daily living (ADLs) and are vulnerable to further functional decline. Multicomponent exercise can help prevent functional decline, but residents with dementia are less likely to receive it and have not often been included in previous intervention studies. The Dementia Moves intervention was designed to fill this gap. It is an individually tailored multicomponent group exercise program with an aerobic warm-up and a focus on moderate to high intensity functional balance and strength training. Investigators will measure the feasibility and effect of the Dementia Moves program on ADLs for LTC residents with moderate to severe dementia (Mini-Mental State Exam of 20 or less). Investigators hypothesize the intervention will be feasible without modification if 16 individuals are recruited over 6 months, 65% of our sample is retained at 6-months, and 75% of the completed exercises are performed at a moderate to high intensity.

Methods: A pre-post pilot study will be used to assess feasibility, safety (rates of falls and adverse events), and change in ADLs at three- and six-months among LTC residents with moderate to severe dementia. A physiotherapist, physiotherapy assistant, and three volunteers will deliver the group-based exercise program to groups of four residents, three times per week, for six months. Assessments will be completed at three- and six-months. Feasibility outcomes include 1) recruitment over six-months; 2) retention at three- and six-month follow-up; and adherence via 3) attendance and 4) proxy and self-reported ratings of exercise intensity. Investigators will also assess fidelity of the intervention through program audits, and audio diaries and interviews to identify barriers and facilitators to implementation of the intervention.

Discussion: The feasibility of the Dementia Moves intervention will be evaluated in LTC residents with dementia, and investigators will examine rates of falls and adverse events and change in ADLs. Investigators will use the collected information to inform a definitive parallel cluster randomized controlled trial. The feasibility of the Dementia Moves intervention will be evaluated in LTC residents with dementia, and investigators will examine rates of falls and adverse events and change in ADLs. Investigators will use the collected information to inform a definitive parallel cluster randomized controlled trial.

Conditions

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Moderate to Severe Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

pre-post pilot feasibility study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dementia Moves

Dementia Moves is a multi-component exercise intervention that was developed to provide evidence informed exercise-based physical rehabilitation for LTC residents with dementia. The intervention is based on a recent systematic review that examined the effectiveness of physical rehabilitation interventions for LTC residents with dementia and a qualitative study that describes the goals of rehabilitation as described by residents, family members, and staff. The systematic review identified common interventions and their effectiveness, outcome measures, and gaps in the literature, while the qualitative study provided perspective on common goals to determine a future primary outcome of interest.

Dementia Moves will be delivered to a group of residents (e.g., 4 residents) for 30 minutes, 3 times per week, for a duration of 6 months by a physiotherapist, physiotherapy assistant, and volunteers.

Group Type EXPERIMENTAL

Dementia Moves

Intervention Type OTHER

Dementia Moves: Dementia Moves is a multicomponent exercise program that can be individually tailored to the abilities of LTC residents with more advanced dementia and focuses on moderate- to high-intensity strength and balance activities with an aim to improve ADLs. Individualized strategies are implemented throughout the intervention to support and promote participation of individuals with more advanced dementia.

Each exercise will be individually prescribed for each participant by the physiotherapists (PT) at the beginning of the program. The intensity of the exercise will be adjusted throughout the program by the PT to ensure the target intensity of moderate to high intensity balance and strength exercises. The intervention will be provided face to face in groups of 4 residents with the PT, PTA, and three volunteers. Though the intervention is delivered in a group setting, the specific exercises that the participants complete are individualized based on their abilities.

Interventions

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Dementia Moves

Dementia Moves: Dementia Moves is a multicomponent exercise program that can be individually tailored to the abilities of LTC residents with more advanced dementia and focuses on moderate- to high-intensity strength and balance activities with an aim to improve ADLs. Individualized strategies are implemented throughout the intervention to support and promote participation of individuals with more advanced dementia.

Each exercise will be individually prescribed for each participant by the physiotherapists (PT) at the beginning of the program. The intensity of the exercise will be adjusted throughout the program by the PT to ensure the target intensity of moderate to high intensity balance and strength exercises. The intervention will be provided face to face in groups of 4 residents with the PT, PTA, and three volunteers. Though the intervention is delivered in a group setting, the specific exercises that the participants complete are individualized based on their abilities.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. A clinical diagnosis of any form of dementia as documented in their electronic medical record
2. a Mini-Mental State Exam Score (MMSE) of 20 or less, or Cognitive Performance Scale (CPS) Score of 3 or higher, indicating moderate to severe cognitive impairment.

Exclusion Criteria

Participants who are receiving end of life care in the LTC
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alzheimer Society of Canada

OTHER

Sponsor Role collaborator

Dalhousie University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caitlin McArthur, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University

Central Contacts

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Caitlin McArthur, PhD

Role: CONTACT

902-494-1371

Niousha Alizadehsaravi, MSc

Role: CONTACT

5069993438

References

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Lane NE, Wodchis WP, Boyd CM, Stukel TA. Disability in long-term care residents explained by prevalent geriatric syndromes, not long-term care home characteristics: a cross-sectional study. BMC Geriatr. 2017 Feb 10;17(1):49. doi: 10.1186/s12877-017-0444-1.

Reference Type BACKGROUND
PMID: 28183274 (View on PubMed)

Helvik AS, Engedal K, Benth JS, Selbaek G. A 52 month follow-up of functional decline in nursing home residents - degree of dementia contributes. BMC Geriatr. 2014 Apr 10;14:45. doi: 10.1186/1471-2318-14-45.

Reference Type BACKGROUND
PMID: 24720782 (View on PubMed)

van Doorn C, Gruber-Baldini AL, Zimmerman S, Hebel JR, Port CL, Baumgarten M, Quinn CC, Taler G, May C, Magaziner J; Epidemiology of Dementia in Nursing Homes Research Group. Dementia as a risk factor for falls and fall injuries among nursing home residents. J Am Geriatr Soc. 2003 Sep;51(9):1213-8. doi: 10.1046/j.1532-5415.2003.51404.x.

Reference Type BACKGROUND
PMID: 12919232 (View on PubMed)

Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.

Reference Type BACKGROUND
PMID: 5420677 (View on PubMed)

Ripley S, Alizadehsaravi N, Affoo R, Hunter S, Middleton LE, Moody E, Weeks LE, McArthur C. Resident-, family-, and staff-identified goals for rehabilitation of long-term care residents with dementia: a qualitative study. BMC Geriatr. 2024 Jan 29;24(1):108. doi: 10.1186/s12877-024-04674-2.

Reference Type BACKGROUND
PMID: 38287257 (View on PubMed)

Telenius EW, Engedal K, Bergland A. Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial. BMC Geriatr. 2015 Dec 3;15:158. doi: 10.1186/s12877-015-0151-8.

Reference Type BACKGROUND
PMID: 26630910 (View on PubMed)

Slaughter SE, Estabrooks CA, Jones CA, Wagg AS. Mobility of Vulnerable Elders (MOVE): study protocol to evaluate the implementation and outcomes of a mobility intervention in long-term care facilities. BMC Geriatr. 2011 Dec 16;11:84. doi: 10.1186/1471-2318-11-84.

Reference Type BACKGROUND
PMID: 22176583 (View on PubMed)

Barisch-Fritz B, Trautwein S, Scharpf A, Krell-Roesch J, Woll A. Effects of a 16-Week Multimodal Exercise Program on Physical Performance in Individuals With Dementia: A Multicenter Randomized Controlled Trial. J Geriatr Phys Ther. 2022 Jan-Mar 01;45(1):3-24. doi: 10.1519/JPT.0000000000000308.

Reference Type BACKGROUND
PMID: 33813533 (View on PubMed)

McArthur C, Alizadehsaravi N, Affoo R, Cooke K, Douglas N, Earl M, Flynn T, Ghanouni P, Hunter S, Middleton L, Moody E, Searle S, Smith C, Weeks L. Effectiveness of physical rehabilitation in improving physical functioning and quality of life for long-term-care residents with dementia: a systematic review protocol. JBI Evid Synth. 2023 Jan 1;21(1):207-213. doi: 10.11124/JBIES-22-00096.

Reference Type BACKGROUND
PMID: 36036561 (View on PubMed)

Bouwstra H, Smit EB, Wattel EM, van der Wouden JC, Hertogh CMPM, Terluin B, Terwee CB. Measurement Properties of the Barthel Index in Geriatric Rehabilitation. J Am Med Dir Assoc. 2019 Apr;20(4):420-425.e1. doi: 10.1016/j.jamda.2018.09.033. Epub 2018 Nov 16.

Reference Type BACKGROUND
PMID: 30448338 (View on PubMed)

Morris JN, Fries BE, Morris SA. Scaling ADLs within the MDS. J Gerontol A Biol Sci Med Sci. 1999 Nov;54(11):M546-53. doi: 10.1093/gerona/54.11.m546.

Reference Type BACKGROUND
PMID: 10619316 (View on PubMed)

Glenny C, Stolee P. Comparing the functional independence measure and the interRAI/MDS for use in the functional assessment of older adults: a review of the literature. BMC Geriatr. 2009 Nov 29;9:52. doi: 10.1186/1471-2318-9-52.

Reference Type BACKGROUND
PMID: 19943969 (View on PubMed)

Hutchinson AM, Milke DL, Maisey S, Johnson C, Squires JE, Teare G, Estabrooks CA. The Resident Assessment Instrument-Minimum Data Set 2.0 quality indicators: a systematic review. BMC Health Serv Res. 2010 Jun 16;10:166. doi: 10.1186/1472-6963-10-166.

Reference Type BACKGROUND
PMID: 20550719 (View on PubMed)

McArthur C, Alizadehsaravi N, Affoo R, Cooke K, Douglas NF, Earl M, Farlie MK, Flynn T, Ghanouni P, Hunter SW, Grant SM, Middleton LE, Moody E, Smith C, Verlinden L, Weeks LE. Dementia Moves: protocol for a feasibility study testing a physical rehabilitation program for long-term care residents with moderate to severe dementia. Pilot Feasibility Stud. 2025 Jul 26;11(1):104. doi: 10.1186/s40814-025-01685-7.

Reference Type DERIVED
PMID: 40713920 (View on PubMed)

Related Links

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http://search.ebscohost.com/login.aspx?direct=true&db=cin20&AN=109794747&site=ehost-live

Bennett CA. An evaluation of fall prevention interventions among older adults in a long term care facility. \[Internet\]. Evaluation of fall prevention interventions among older adults in a long term care facility. University of Southern Mississippi; 201

Other Identifiers

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22-17

Identifier Type: -

Identifier Source: org_study_id

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