Dementia Moves: Protocol for a Pilot Feasibility Study Testing a Physical Rehabilitation Program for Long-Term Care Residents With Moderate to Severe Dementia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Intensity of exercises - balance
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants who are receiving end of life care in the LTC
结局指标
主要结局
Intensity of exercises - balance
时间窗: 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.
Number of residents recruited from participating homes
时间窗: 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.
Intensity of exercises - resistance and aerobic exercise
时间窗: 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.
Participation rates
时间窗: 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
时间窗: 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%.
次要结局
- Activities of daily living (interRAI Long-Term Care Facilities Long Form Score)(At enrollment, three- and six-month follow ups)
- Number of hospitalization(three-months prior to baseline, baseline to three-months, and three- to six-month periods.)
- Fall frequency(three-months prior to baseline, baseline to three-months, and three- to six-month periods)
- 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)