AzTrials
AzTrials

Cognitive ImpairmentOASISNCT06150339

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

A study testing OASIS Walking Intervention in people with Cognitive Impairment and Dementia, run by University Health Network, Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cognitive Impairment, Dementia, Delirium
What is being tested?
OASIS Walking Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesCanada
Study dates
1 Mar 2024to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • aged 65 years and older;
  • 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)
  • admitted to a transitional care unit after a hospitalization
  • can speak English
  • has received clearance from the physiotherapist to participate in the study
  • has received clearance from the nurse practitioner to participate in the study
Show all 10Show fewer
  • were community-dwelling (lived in a home or retirement home; not a nursing home) prior to hospitalization
  • were able to walk independently or with the assistance of one person (with or without a gait aid) prior to hospital admission
  • is currently able to ambulate either independently or with the assistance of one person (with or without a gait aid)
  • has a care partner (family member, friend) who is willing participate in an interview about the patient for the study.

Who cannot join

  • 1) Palliative (having <six months prognosis as documented in the medical chart)

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

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

    Pickering, Ontario, L1W 2B2

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

    Scarborough Village, Ontario, M1H 3A1

Other trials in Canada

About this study

Official title: The OASIS Walking Study - Older Adults With Cognitive Impairment Performing Sit to Stands and Walking in Transitional Care Programs: A Feasibility Study

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:

Read more
  • 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.
Read the detailed description

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.

Being tested
OASIS Walking Intervention
Keywords
Cognitive Impairment, Dementia, Delirium, Functional Decline, Walking, Walking Program, Activity, Sit to Stand, Chair Stand, Nurse-led, Mobility, Feasibility, Intervention, Quasi-experimental
Medical subject headings
Cognitive Dysfunction, Dementia, Delirium, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OASIS Walking InterventionOther

    Communication Care Plan, Sit to Stand Activity, Walking Program

Study groups in NCT06150339
Study groupRoleWhat they receive
Long-term Care Stream or Rehab Stream Intervention ArmExperimentalIntervention 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.
Receives: Other: OASIS Walking Intervention
Reactivation Stream Intervention ArmExperimentalIntervention 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.
Receives: Other: OASIS Walking Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Recruitment rate will be calculated as the percentage of participants who enroll in the study out of the total number of eligible participants

    Measured: From start of recruitment to end of recruitment (6 months)

  2. Retention rate

    Retention rate will be calculated as the percentage of participants who complete the study (i.e., receive the full dose of the intervention and provided post-test outcome data) out of the number of participants who were enrolled (i.e., signed a consent form and provided baseline data)

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

  3. Adherence (Level of engagement with the treatment [percentage]).

    The level of engagement with the treatment (percentage). For this study, the planned number of sessions is five per week for 6 weeks for a total of 30 sessions.

    Percentage = the number of sessions attended divided by the total number of sessions (30 sessions)

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

  4. Adherence (Average number of treatment sessions attended)

    Average number of treatment sessions attended

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

  5. Adherence (Average duration of each intervention session)

    The average duration of each intervention session (in minutes)

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

  6. Adherence (Average duration of each walking session)

    The average duration of each walking session (in minutes)

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

  7. Adherence (Average number of sit to stands done per session)

    Average number of sit to stands done per session.

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

  8. Adherence (Level of engagement with sit to stands [percentage])

    Percentage = number of sit to stands done per session, divided by the goal number of sit to stands.

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

Secondary outcomes (12)

  1. Participant Satisfaction (for Long-Term Care Stream or Rehab Stream Arm)

    8-Item Client Satisfaction Questionnaire (CSQ-8) + 3 Open-Ended Questions. The CSQ-8 has a minimum value is 8, the maximum value is 32. Higher scores mean a better outcome.

    Measured: Posttest (Immediately after 6-week intervention) (Time 3)

  2. Participant Satisfaction (for Reactivation Stream Intervention Arm)

    8-Item Client Satisfaction Questionnaire (CSQ-8) + 3 Open-Ended Questions. The CSQ-8 has a minimum value is 8, the maximum value is 32. Higher scores mean a better outcome.

    Measured: Posttest (Immediately after 3-week intervention) (Time 3)

  3. Lower extremity muscle strength (for Long-Term Care Stream or Rehab Stream Arm)

    time to perform one sit-to-stand

    Measured: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)

  4. Lower extremity muscle strength (for Reactivation Stream Intervention Arm)

    time to perform one sit-to-stand

    Measured: Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3)

  5. Mobility (for Long-Term Care Stream or Rehab Stream Arm)

    2-minute walk test

    Measured: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)

  6. Mobility (for Reactivation Stream Intervention Arm)

    2-minute walk test

    Measured: Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3)

  7. Functional Status (for Long-Term Care Stream or Rehab Stream Arm)

    Barthel Index (BI). The BI has a minimum value of 0 and a maximum value of 20. Higher scores mean a better outcome.

    Measured: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)

  8. Functional Status (for Reactivation Stream Intervention Arm)

    Barthel Index (BI). The BI has a minimum value of 0 and a maximum value of 20. Higher scores mean a better outcome.

    Measured: Pretest Initial Assessment (Time 1); After 1.5 weeks of intervention (Time 2); Posttest (Immediately after 3-week intervention) (Time 3)

  9. Patient's Quality of Life (for Long-Term Care Stream or Rehab Stream Arm)

    The Quality of Life-AD Measure (QOL-AD). The QOL-AD is a 13-item questionnaire. Participants rate each item on a 4-point scale, with 1 being poor and 4 being excellent. The minimum score is 13 and the maximum score is 52. Higher scores mean a better outcome.

    Measured: Pretest Initial Assessment (Time 1); After 3 weeks of intervention (Time 2); Posttest (Immediately after 6-week intervention) (Time 3)

  10. Discharge destination (for Long-Term Care Stream or Rehab Stream Arm)

    Discharge destination after TCP

    Measured: At the time of discharge from the TCU or within 60 days of admission to TCP, whichever comes first.

  11. Discharge destination (for Reactivation Stream Intervention Arm)

    Discharge destination after TCP

    Measured: At the time of discharge from the TCU or within 60 days of admission to TCP, whichever comes first.

  12. Intervention fidelity (percentage)

    Intervention fidelity will also be measured through the interventionist's self-report of 12 intervention items. The percentage will be calculated as the number of items done divided by the 12 items on the intervention fidelity checklist. Minimum value is 0%, maximum value is 100%. A higher percentage means a better outcome (greater intervention fidelity).

    Measured: Calculated at the end of the study (6 months + 6 weeks from the start of recruitment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study start1 Mar 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Single group
Model description
This is a feasibility study which will use a quasi-experimental one group time series design.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06150339
Sponsor's protocol ID
23-5543
Acronym
OASIS
Status last verified
Apr 2026
First submitted
27 Oct 2023
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39283901

Questions about this trial

What is this clinical trial studying?

A study testing OASIS Walking Intervention in people with Cognitive Impairment and Dementia, run by University Health Network, Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: From start of recruitment to end of recruitment (6 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06150339, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in