Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400108
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-23
Brief Title:
Dementia Moves Protocol for a Feasibility Study
Sponsor:
Dalhousie University
Organization:
Dalhousie University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 barriersfacilitators 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 ie falls fractures hospitalizations emergency department visits for LTC residents with moderate to severe dementia ie Mini-Mental State Exam of 20 or less
Through a parallel cluster randomized controlled trial investigators will measure the effect of the Dementia Moves program on ADLs and adverse events ie falls fractures hospitalizations emergency department visits for LTC residents with moderate to severe dementia ie 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None