Older Adults With Cognitive Impairment Doing Sit to Stands, Walking in Transitional Care Programs: A Feasibility Study

NCT ID: NCT06150339

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-06-30

Brief Summary

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The goal of this intervention study is to test the effects of a nurse-led mobility intervention (known as the OASIS Walking Intervention (Older Adults performing Sit to Stands and Walking Intervention)) in older adults with cognitive impairment, such as dementia, in transitional care programs.

The main questions this study aims to answer are:

* Is the study doable and are older adults satisfied with the intervention?
* Does the intervention improve older adults' muscle strength, mobility, functional status and quality of life?

Participants will be asked to do the following:

1. Be interviewed once so that a patient-centred communication care plan can be made
2. Do sit to stand activity
3. Walk as part of a walking program.

Detailed Description

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The purpose of this study is to determine the feasibility of and satisfaction of participants with a novel intervention - the OASIS Walking Intervention (that is, the Older Adults with cognitive impairment performing Sit to Stands and Walking Intervention) in a facility-based TCPs.

The second aim is to determine the efficacy of the OASIS Walking intervention on muscle strength, mobility, functional status, quality of life, and discharge destination.

A feasibility study will be undertaken for this three-component intervention project. In terms of study design, a quasi-experimental one group time series design will be used.

A sample size of 26 patient participants and their substitute decision makers will participate in the study. Participants will be older adults ≥65 years admitted to a facility-based transitional care unit in Ontario.

The Older Adults with cognitive impairment performing the Sit to Stands and Walking Intervention is a nurse-led intervention that consists of three components: 1) Patient-Centered Communication Care Plan (informed by interviews with the participant and their care partner); 2) Sit to Stand Activity; and 3) Walking program. This intervention is grounded using a patient centered approach.

For patients in the Long-Term Care Stream or Rehab Stream Arm, the dose of the intervention is: up to 45 minutes per session, five sessions per week, for six weeks. Approximately up to 30 minutes will be spent walking with the participant and up to 15 minutes will be spent performing the sit-to-stand activity.

For patients in the Reactivation Stream Intervention Arm, the dose of the intervention is: up to 45 minutes per session, five sessions per week, for three weeks. Approximately up to 30 minutes will be spent walking with the participant and up to 15 minutes will be spent performing the sit-to-stand activity.

Conditions

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Cognitive Impairment Dementia Delirium Functional Decline

Keywords

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Cognitive Impairment Dementia Delirium Functional Decline Walking Walking Program Activity Sit to Stand Chair Stand Nurse-led Mobility Feasibility Intervention Quasi-experimental

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a feasibility study which will use a quasi-experimental one group time series design.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Long-term Care Stream or Rehab Stream Intervention Arm

Intervention Dose: Up to 45 minutes per session, 5 sessions per week, for 6 weeks. Approximately up to 30 minutes will be spent walking; up to 15 minutes will be spent performing sit-to-stands.

Intervention Components:

Component 1: Patient-Centered Communication Care Plan. A patient-centered communication care plan will be created, to promote enjoyment and engagement during the sessions. The care plan will be informed by interviews with the participant and their care partner.

Component 2: Sit to Stand Activity. A target number of sit to stands per session will be determined based on a baseline assessment and according to an algorithm; the target will be progressed halfway into the intervention.

Component 3: Walking Program. Based on the findings from the patient-centered assessment interviews as well as the performance of the participants on a walk test at baseline (Time 1), an individualized walking program will be carried out with participants.

Group Type EXPERIMENTAL

OASIS Walking Intervention

Intervention Type OTHER

Communication Care Plan, Sit to Stand Activity, Walking Program

Reactivation Stream Intervention Arm

Intervention Dose: up to 45 minutes per session, five sessions per week, for 3 weeks. Approximately up to 30 minutes will be spent walking with the participant and up to 15 minutes will be spent performing the sit-to-stands.

Component 1: Patient-Centered Communication Care Plan. A patient-centered communication care plan will be created, to promote enjoyment and engagement during the sessions. The care plan will be informed by interviews with the participant and their care partner.

Component 2: Sit to Stand Activity. A target number of sit to stands per session will be determined based on a baseline assessment and according to an algorithm; the target will be progressed halfway into the intervention.

Component 3: Walking Program. Based on the findings from the patient-centered assessment interviews as well as the performance of the participants on a walk test at baseline (Time 1), an individualized walking program will be carried out with participants.

Group Type EXPERIMENTAL

OASIS Walking Intervention

Intervention Type OTHER

Communication Care Plan, Sit to Stand Activity, Walking Program

Interventions

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OASIS Walking Intervention

Communication Care Plan, Sit to Stand Activity, Walking Program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. aged 65 years and older;
2. have cognitive impairment (dementia, delirium, cognitive impairment, or unspecified cognitive impairment) as documented in the medical record or Quick Dementia Rating Scale (QDRS) score of ≥2)
3. admitted to a transitional care unit after a hospitalization
4. can speak English
5. has received clearance from the physiotherapist to participate in the study
6. has received clearance from the nurse practitioner to participate in the study
7. were community-dwelling (lived in a home or retirement home; not a nursing home) prior to hospitalization
8. were able to walk independently or with the assistance of one person (with or without a gait aid) prior to hospital admission
9. is currently able to ambulate either independently or with the assistance of one person (with or without a gait aid)
10. has a care partner (family member, friend) who is willing participate in an interview about the patient for the study.

Exclusion Criteria

1\) Palliative (having \<six months prognosis as documented in the medical chart)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine S McGilton, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Abbeylawn Retirement Home Transitional Care Unit (Operated by Bayshore Health Care)

Pickering, Ontario, Canada

Site Status RECRUITING

Cedarbrook Lodge Retirement Home Transitional Care Unit (Operated by Bayshore Health Care)

Scarborough Village, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Katherine S McGilton, PhD

Role: CONTACT

Phone: 416 597 3422

Email: [email protected]

Tracey JF Colella, PhD

Role: CONTACT

Phone: 416 597 3422

Email: [email protected]

Facility Contacts

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Jennifer Roberts

Role: primary

Jennifer Roberts

Role: primary

References

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Cumal A, Colella TJF, Puts MT, McGilton KS. The OASIS walking study-Older adults with cognitive impairment performing sit to stands and walking in transitional care programs: Protocol for a feasibility study. PLoS One. 2024 Sep 16;19(9):e0308268. doi: 10.1371/journal.pone.0308268. eCollection 2024.

Reference Type DERIVED
PMID: 39283901 (View on PubMed)

Other Identifiers

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23-5543

Identifier Type: -

Identifier Source: org_study_id