An interventional study of Dementia Moves in Moderate to Severe Dementia, sponsored by Dalhousie University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-05-06.
Sponsored by Dalhousie University · Not applicable, Interventional, and Supportive care
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).
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 16 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Dalhousie University is the lead sponsor of 50 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who are receiving end of life care in the LTC
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
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.
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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: 3- and 6-month follow-ups.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: three-months prior to baseline, baseline to three-months, and three- to six-month periods.
No study locations are listed for this record.
Plan to share: No
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