Mobility of Vulnerable Elders (MOVE): Translating Knowledge to Health Care Aides in Long-term Care Facilities (MOVE)

January 25, 2017 updated by: University of Alberta
Almost 90 percent of residents living in long-term care facilities have some type of mobility limitation, which worsens quickly once they move into a long-term care facility. This means that they cannot easily walk or move around in their day-to-day lives and this can have serious consequences for their general health and well-being. Researchers have shown that exercise can help the mobility of even the oldest of adults but elderly residents in long-term care facilities still commonly sit or lie in bed for long periods of time, in many cases for most of their waking hours. The purpose of this research is to study the effect of a simple physical activity on the mobility and quality of life of residents in long-term care facilities. Researchers will introduce a sit-to-stand activity to health care aides which will become part of their daily routine with residents. The basic sit-to-stand movement is already a part of the daily activities that health care aides do with residents. Specifically, health care aides will ask residents to repeat the sit-to-stand activity at mealtimes, when using the toilet, and on other occasions of daily activity. An important part of this research is to find out how well the activity preserves the ability of residents to stay mobile and also to examine how this will improve their quality of life in the home. The MOVE study will demonstrate whether it is possible to delay the loss of mobility in long-term care residents by incorporating the sit-to-stand activity into the regular practice of health care aides.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5J 3M9
        • CapitalCare Continuing Care
      • Edmonton, Alberta, Canada, T6C 4G8
        • Good Samaritan Society
      • Edmonton, Alberta, Canada, T6E 6A8
        • Extendicare
      • Edmonton, Alberta, Canada, T6K 2R1
        • Shepherd's Care Foundation

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have a diagnosis of Alzheimer disease, vascular dementia, or mixed dementia
  • are able to transfer independently or with the assistance of one person

Exclusion Criteria:

  • have a diagnosis of fronto-temporal or Lewy-body dementia
  • require the assistance of more than one person to transfer, or a transfer lift

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Sit-to-Stand Activity
Other: Sit-to-Stand Activity
Health care aides will be expected to prompt residents to repeatedly stand up and sit down on four occasions throughout the day (twice on each of the day and evening shifts). The number of repetitions on each occasion will vary according to residents' ability and fatigue. The sit-to-stand activity is to be integrated into usual care routines such as when entering the dining room at mealtimes, while toileting, and on other occasions of regular activity. The timing and location will be at the discretion of the health care aide.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mobility at 3 and 6 months
Time Frame: Baseline, 3-Months, 6-Months
The sit-to-stand action is a functional activity that has been incorporated into a number of mobility measures. We have chosen to measure mobility using the number of sit-to-stands in 30 seconds because in the frail nursing home population many residents have difficulty transferring (e.g.standing up from a chair). In our pilot study we found many residents were unable to complete more than two or three sit-to-stands. Residents will be instructed to stand up and sit down as many times as possible until they are asked to stop after 30 seconds (Jones, Rikli, & Beam, 1999).
Baseline, 3-Months, 6-Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Function at 3 and 6 months
Time Frame: Baseline, 3-Months, 6-Months
The Functional Independence Measure (FIM) is an 18-item performance-based instrument which assesses the amount of assistance required to complete basic activities of daily living using a 7-point scale graded from 1 (dependent) to 7 (independent) (Jones & Feeny, 2006).
Baseline, 3-Months, 6-Months
Change from Baseline in Health Related Quality of Life at 3 and 6 months
Time Frame: Baseline, 3-Months, 6-Months
The Health Utilities Index Mark 2 and 3 (HUI2/3) is a generic health related quality of life questionnaire based on two generic multi-attribute preference-based systems: the HUI2 and the HUI3. The HUI2 assesses capacity on six dimensions (or attributes) of health status: sensation (vision, hearing, and speech), mobility, emotion, cognition, self-care, and pain. The HUI3 consists of eight attributes: vision; hearing; speech; ambulation; dexterity; emotion; cognition; and, pain (Furlong, et al., 2011).
Baseline, 3-Months, 6-Months
Change from Baseline in Dementia Specific Quality of Life at 3 and 6 Months
Time Frame: Baseline, 3-Months, 6-Months
The Quality of Life-Alzheimer's Disease (QofL-AD) was developed to capture the domains considered important to quality of life in Lawton's broad conceptual framework: the interpersonal; environmental; functional; physical; and, psychological domains. The 13 items including physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, fun, money, life as a whole scored on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent) (Lawton, 1983; 1991).
Baseline, 3-Months, 6-Months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
CapitalCare Continuing Care
Extendicare
Good Samaritan Society
Shepherd's Care Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Slaughter, RN, PhD, University of Alberta

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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DPA 108891

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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