Dementia Moves: Protocol for a Feasibility Study

NCT06400108 | Not Yet Recruiting

• 1 other identifier: 22-17
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Moderate to Severe Dementia

Outcome Measures

Primary Outcomes (5)

• Number of residents recruited from participating homes

  Investigators plan to recruit eight residents from each of the two participating homes, distributing our recruitment efforts evenly between them. To manage recruitment efficiently, investigators will alternate our focus between the two homes on a monthly basis. For instance, in the first month, recruitment will be on participants from Home A, then shift our focus to Home B in the second month, and so forth. A target recruitment numbers align with previous studies in long-term care settings for residents with dementia, where successful recruitment has ranged from 12 to 26 residents per home per year. By aiming slightly higher with a total of 16 participants over six months, investigators maintain feasibility while ensuring an adequately sized sample for meaningful analysis.

  The recruitment will occur over a six-month period,

• Participation rates

  Investigators will report the number and percentage of potential participants who are eligible, provide consent, and begin the intervention. The criterion for success is that 80% of eligible participants will complete baseline testing, and attend the first intervention session. Number and percentage of participants who complete three- and six-month follow-ups. Criteria for success: A total of 13 (81.3%) and 10 (65%) residents will complete three- and six-month follow-ups, respectively.

  3 to 6 months follow-ups.

• Attendance rates

  The physiotherapist will take attendance at each exercise session and will document the reason if the resident does not attend (i.e., does not wish to participate, unwell, in hospital, at another activity, or other). Based on the results of previous physical rehabilitation studies for LTC residents with dementia, the criterion for success is the average proportion of exercise sessions attended will be 70%.

  3- and 6-month follow-ups.

• Intensity of exercises - resistance and aerobic exercise

  Intensity will be assessed using proxy reports from the study team members and self-reports from the participants. The rate of perceived exertion (RPE) scale used for aerobic and strength exercises which is scored from 0-10, where 0 indicates lower intensity and 10 indicates higher intensity. This information will be recorded by a research assistant throughout the sessions to ensure accurate reporting.

  3- and 6-month follow-ups.

• Intensity of exercises - balance

  Intensity will be assessed using proxy reports from the study team members and self-reports from the participants. The Balance Intensity Scale Therapist Reported (BIS-T) and Exerciser Reported (BIS-E) will be used for balance exercises. The BIS-T is scored from 0-100 where a higher number indicates a higher intensity. The BIS-E is scored from 1 to 5 where a higher score indicates more intensity. This information will be recorded by a research assistant throughout the sessions to ensure accurate reporting.

  3- and 6-month follow-ups.

Secondary Outcomes (5)

• Emergency department visits

  three-months prior to baseline, baseline to three-months, and three- to six-month periods.

• Activities of daily living (Barthel Index)

  baseline at enrollment

• Activities of daily living (interRAI Long-Term Care Facilities Long Form Score)

  At enrollment, three- and six-month follow ups

• Fall frequency

  three-months prior to baseline, baseline to three-months, and three- to six-month periods

• Number of hospitalization

  three-months prior to baseline, baseline to three-months, and three- to six-month periods.

Study Arms (1)

Dementia Moves

EXPERIMENTAL

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.

Other: Dementia Moves

Interventions

Dementia Moves 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.

Dementia Moves

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of any form of dementia as documented in their electronic medical record
• 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.

You may not qualify if:

• Participants who are receiving end of life care in the LTC

Sponsors & Collaborators

• Dalhousie University: lead
• Alzheimer Society of Canada: collaborator

Related Publications (14)

• 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.

  PMID: 28183274 BACKGROUND

• 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.

  PMID: 24720782 BACKGROUND

• 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.

  PMID: 12919232 BACKGROUND

• 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.

  PMID: 5420677 BACKGROUND

• 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.

  PMID: 38287257 BACKGROUND

• 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.

  PMID: 26630910 BACKGROUND

• 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.

  PMID: 22176583 BACKGROUND

• 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.

  PMID: 33813533 BACKGROUND

• 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.

  PMID: 36036561 BACKGROUND

• 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.

  PMID: 30448338 BACKGROUND

• 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.

  PMID: 10619316 BACKGROUND

• 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.

  PMID: 19943969 BACKGROUND

• 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.

  PMID: 20550719 BACKGROUND

• 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.

  PMID: 40713920 DERIVED

Related Links

• 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

Study Officials

• Caitlin McArthur, PhD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin McArthur, PhD

CONTACT

902-494-1371; caitlin.mcarthur@dal.ca

Niousha Alizadehsaravi, MSc

CONTACT

5069993438; niousha.alz@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre-post pilot feasibility study

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 6, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share