Dementia Moves: Protocol for a Feasibility Study

May 2, 2024 updated by: Dalhousie University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. A clinical diagnosis of any form of dementia as documented in their electronic medical record
  2. 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.

Exclusion Criteria:

Participants who are receiving end of life care in the LTC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dementia Moves

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The recruitment will occur over a six-month period,
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.
3 to 6 months follow-ups.
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%.
3- and 6-month follow-ups.
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.
3- and 6-month follow-ups.
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.
3- and 6-month follow-ups.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency department visits
Time Frame: three-months prior to baseline, baseline to three-months, and three- to six-month periods.
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.
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
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.
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
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.
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
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.
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.
Number of hospitalization will be recorded and reported.
three-months prior to baseline, baseline to three-months, and three- to six-month periods.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalhousie University

Collaborators

Alzheimer Society of Canada

Investigators

  • Principal Investigator: Caitlin McArthur, PhD, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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