Moderate to Severe DementiaNCT06400108
Dementia Moves: Protocol for a Feasibility Study
A study testing Dementia Moves in people with Moderate to Severe Dementia, run by Dalhousie University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Moderate to Severe Dementia
- What is being tested?
- Dementia Moves
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who are receiving end of life care in the LTC
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dementia Moves: Protocol for a Pilot Feasibility Study Testing a Physical Rehabilitation Program for Long-Term Care Residents With Moderate to Severe Dementia
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).
Read the detailed description
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
- Moderate to Severe Dementia
- Being tested
- Dementia Moves
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia MovesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dementia Moves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 3- and 6-month follow-ups.
Secondary outcomes (5)
Emergency department visits
The number of visits to the emergency department related and unrelated to the intervention will be reported by the investigators. This includes any visits that may be directly or indirectly related to the intervention, such as those for injuries sustained during exercise sessions or for unrelated health issues. The goal is to provide a comprehensive understanding of the impact of the intervention on residents' health and well-being, including any potential risks or benefits associated with the program.
Measured: three-months prior to baseline, baseline to three-months, and three- to six-month periods.
Activities of daily living (Barthel Index)
The Barthel Index measures the level of independence in ADLs. The survey consists of 10 performance items (e.g. toilet use, dressing) and each item can be rated on a two, three- or four-point scale indicating the level of help needed for a total of 20 possible points, where a higher score indicates a higher level of functional independence. The survey will be completed by a research assistant through consultation with the nursing staff on each resident's home unit. The Barthel Index is a reliable and valid measure of functional disability and demonstrates excellent inter-rater reliability when used to assess ADLs in LTC homes.
Measured: baseline at enrollment
Activities of daily living (interRAI Long-Term Care Facilities Long Form Score)
The interRAI ADL Long Form Scale is a summary scale where each ADL has six possible categories of response ranging from 0 (total independence) to 4 (total dependence) and a score of 8 is assigned if the activity was not performed. The ADL Long Form Scale is the sum of the responses to all seven individual ADL items (bed mobility, transfer, locomotion, dressing, eating, toilet use, personal hygiene) with scores ranging from 0 to 28, where a higher score indicates more dependence. The ADL items that form the scale are collected from the interRAI LTC Facilities Instrument, a valid and reliable comprehensive assessment. It is completed for all LTC residents in Nova Scotia upon admission to the home, every three months thereafter, or if there is a significant change in the resident's health status.
Measured: At enrollment, three- and six-month follow ups
Fall frequency
The number of falls that participants experience will be recorded and reported. This information is important for evaluating the effectiveness of the intervention in reducing fall incidents among the study population.
Measured: three-months prior to baseline, baseline to three-months, and three- to six-month periods
Number of hospitalization
Number of hospitalization will be recorded and reported.
Measured: three-months prior to baseline, baseline to three-months, and three- to six-month periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study startSep 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pre-post pilot feasibility study
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Responsible party
- Sponsor
- Investigators
- Caitlin McArthur, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400108
- Sponsor's protocol ID
- 22-17
- Status last verified
- May 2024
- First submitted
- 23 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28183274Helvik 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.
PubMed 24720782van 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.
PubMed 12919232Katz 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.
PubMed 5420677Ripley 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.
PubMed 38287257Telenius 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.
PubMed 26630910Slaughter 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.
PubMed 22176583Barisch-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.
PubMed 33813533McArthur 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.
PubMed 36036561Bouwstra 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.
PubMed 30448338Morris 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.
PubMed 10619316Glenny 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.
PubMed 19943969Hutchinson 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.
PubMed 20550719McArthur 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.
PubMed 40713920
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Moves: Protocol for a Pilot Feasibility Study Testing a Physical Rehabilitation Program for Long-Term Care Residents With Moderate to Severe Dementia
- ClinicalTrials.gov ID
- NCT06400108
- Acronym / sponsor ID
- 22-17
- Conditions
- Moderate to Severe Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Alzheimer Society of Canada
- Study start
- Sep 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pre-post pilot feasibility study
| Arm | Type | Receives |
|---|---|---|
| Dementia Moves | Experimental | Other: Dementia MovesDementia 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who are receiving end of life care in the LTC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dementia MovesDementia 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. | Other | Dementia Moves |
Primary outcome
Number of residents recruited from participating homes
Time frame: The recruitment will occur over a six-month period,
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.
Participation rates
Time frame: 3 to 6 months follow-ups.
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.
Attendance rates
Time frame: 3- and 6-month follow-ups.
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%.
Intensity of exercises - resistance and aerobic exercise
Time frame: 3- and 6-month follow-ups.
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.
Intensity of exercises - balance
Time frame: 3- and 6-month follow-ups.
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.
5 secondary outcomes
Emergency department visits
Time frame: three-months prior to baseline, baseline to three-months, and three- to six-month periods.
Activities of daily living (Barthel Index)
Time frame: baseline at enrollment
Activities of daily living (interRAI Long-Term Care Facilities Long Form Score)
Time frame: At enrollment, three- and six-month follow ups
Fall frequency
Time frame: three-months prior to baseline, baseline to three-months, and three- to six-month periods
Number of hospitalization
Time frame: three-months prior to baseline, baseline to three-months, and three- to six-month periods.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Background: PubMed 28183274Lane 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.
- Background: PubMed 24720782Helvik 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.
- Background: PubMed 12919232van 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.
- Background: PubMed 5420677Katz 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.
- Background: PubMed 38287257Ripley 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.
- Background: PubMed 26630910Telenius 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.
- Background: PubMed 22176583Slaughter 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.
- Background: PubMed 33813533Barisch-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.
- Background: PubMed 36036561McArthur 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.
- Background: PubMed 30448338Bouwstra 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caitlin McArthur, PhD principal investigator
Dalhousie University
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Moves in people with Moderate to Severe Dementia, run by Dalhousie University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caitlin McArthur, PhD (902-494-1371, caitlin.mcarthur@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of residents recruited from participating homes (time frame: The recruitment will occur over a six-month period,). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06400108, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024; AzTrials last refreshed its copy on 27 Oct 2026.