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

NCT06150339 | Completed

• 1 other identifier: 23-5543
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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

Conditions

Cognitive Impairment; Dementia; Delirium; Functional Decline

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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

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

• 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)

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

• 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)

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

• Adherence (Average number of treatment sessions attended)

  Average number of treatment sessions attended

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

• Adherence (Average duration of each intervention session)

  The average duration of each intervention session (in minutes)

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

• Adherence (Average duration of each walking session)

  The average duration of each walking session (in minutes)

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

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

  Average number of sit to stands done per session.

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

• 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.

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

Secondary Outcomes (12)

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

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

• Participant Satisfaction (for Reactivation Stream Intervention Arm)

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

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

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

• Lower extremity muscle strength (for Reactivation Stream Intervention Arm)

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

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

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

Study Arms (2)

Long-term Care Stream or Rehab Stream Intervention Arm

EXPERIMENTAL

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.

Other: OASIS Walking Intervention

Reactivation Stream Intervention Arm

EXPERIMENTAL

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.

Other: OASIS Walking Intervention

Interventions

OASIS Walking Intervention OTHER

Communication Care Plan, Sit to Stand Activity, Walking Program

Long-term Care Stream or Rehab Stream Intervention Arm; Reactivation Stream Intervention Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

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

Pickering, Ontario, L1W 2B2, Canada

Location

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

Scarborough Village, Ontario, M1H 3A1, Canada

Location

Related Publications (1)

• 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.

  PMID: 39283901 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Delirium; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Katherine S McGilton, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a feasibility study which will use a quasi-experimental one group time series design.

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 29, 2023
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)