Walking Intervention for Cognitive Impairment

(OASIS Trial)

Recruiting at 2 trial locations

Overseen By Tracey JF Colella, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Palliative

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the OASIS Walking Intervention, a special walking and exercise program, can benefit older adults with cognitive issues, such as dementia, who are in transitional care after a hospital stay. The researchers aim to determine if this program can improve muscle strength, mobility, and overall quality of life. Participants will engage in activities like sit-to-stands and follow a personalized walking plan. This trial suits individuals over 65 with cognitive impairment who can walk with some assistance and have a care partner willing to participate in an interview. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance care for individuals with cognitive challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the OASIS Walking Intervention is safe for older adults with cognitive impairment?

Research shows that the OASIS Walking Intervention is safe for older adults with memory problems, such as dementia. Studies have found that many people join and stick with the program, demonstrating their willingness and ability to continue. Importantly, participants showed significant improvements in physical abilities, such as faster walking times, indicating the program is well-tolerated.

Walking programs like this one are generally safe for older adults. They involve simple activities like walking and standing up, which carry low risk. Studies have reported no serious side effects, and participants usually find the program enjoyable and engaging. This suggests it is unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OASIS Walking Intervention for cognitive impairment because it offers a personalized approach to exercise, unlike typical treatments such as medications and cognitive training. This intervention incorporates a patient-centered communication care plan, which tailors the experience to individual preferences and needs, enhancing engagement and enjoyment. Additionally, the program combines physical activities like walking and sit-to-stand exercises, which are customized based on each participant's baseline assessment, potentially leading to more effective and quicker improvements in cognitive function. By focusing on personalization and physical activity, this method provides a unique way to support cognitive health.

What evidence suggests that the OASIS Walking Intervention is effective for cognitive impairment?

Research has shown that the OASIS Walking Program can greatly improve physical abilities in older adults with memory or thinking problems. One study found that participants moved better, taking almost 9 seconds less to complete a simple mobility test called the Timed Up-and-Go. They also walked farther in a two-minute walking test, covering an extra 27 meters on average. This trial will test the OASIS Walking Intervention in two different arms: the Long-term Care Stream or Rehab Stream Intervention Arm and the Reactivation Stream Intervention Arm. These findings suggest that the program can effectively strengthen muscles and improve movement. By focusing on exercises like standing up from a chair and walking, this program aims to enhance overall physical function and quality of life. ^{1 2 3 4 5}

Who Is on the Research Team?

Katherine S McGilton, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 and over with cognitive impairments like dementia, who were living at home before hospitalization. They must be able to walk (with or without help), speak English, have a care partner willing to interview, and get clearance from both a physiotherapist and nurse practitioner.

Inclusion Criteria

Were community-dwelling prior to hospitalization

I could walk by myself or with someone's help before I was admitted to the hospital.

My physiotherapist has approved my participation in this study.

Exclusion Criteria

I have been diagnosed with Parkinson's disease.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the OASIS Walking Intervention, which includes a Patient-Centered Communication Care Plan, Sit to Stand Activity, and Walking Program.

6 weeks for Long-term Care Stream or Rehab Stream; 3 weeks for Reactivation Stream

5 sessions per week

Follow-up

Participants are monitored for satisfaction, muscle strength, mobility, functional status, and quality of life after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OASIS Walking Intervention

Trial Overview

The study tests the OASIS Walking Intervention which includes sit-to-stand exercises and walking programs led by nurses. It aims to see if this can improve muscle strength, mobility, functional status, and quality of life in cognitively impaired seniors.

How Is the Trial Designed?

Group I: Reactivation Stream Intervention Arm Experimental Treatment 1 Intervention

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 II: Long-term Care Stream or Rehab Stream Intervention Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

A 1-year moderate-intensity walking program (MI-WP) significantly improved aerobic fitness in older adults with mild cognitive impairment (MCI), with 122 participants showing good attendance (71% median).

While there were small associations between attendance and cognitive function, these were not significant when comparing both the MI-WP and a low-intensity activity program (LI-AP) together, indicating that the primary benefit of the MI-WP was in enhancing aerobic fitness rather than cognitive improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a walking program for community-dwelling older adults with mild cognitive impairment. van Uffelen, JG., Chinapaw, MJ., Hopman-Rock, M., et al.[2019]

A 24-week walking program for 21 elderly nursing home residents with late-stage Alzheimer's disease led to significant improvements in physical performance (20% increase in the 6-minute walking test) and daily living activities (23% improvement in the Barthel index).

While the control group experienced a decline in cognitive function (47% decrease in MMSE scores), the walking group showed a slower decline (-13%), suggesting that physical activity can help stabilize cognitive dysfunction in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month walking program changes cognitive and ADL performance in patients with Alzheimer. Venturelli, M., Scarsini, R., Schena, F.[2022]

The multifaceted walking intervention (MWI) was highly feasible and acceptable, with 86% recruitment and 94% adherence rates among 25 long-term care residents with dementia over a 4-month period.

Participants showed significant improvements in functional mobility and quality of life, including faster Timed Up-and-Go times and increased distances in the Two-Minute Walk Test, indicating that person-centered physical activity can effectively support residents with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Feasibility Study of a Multifaceted Walking Intervention to Maintain the Functional Mobility, Activities of Daily Living, and Quality of Life of Nursing Home Residents With Dementia. Chu, CH., Puts, M., Brooks, D., et al.[2021]

A systematic review of 36 studies found that exercise programs focusing on strength and balance, especially when combined with functional mobility training, significantly improve gait in older adults with mild cognitive impairment or dementia.

Cognitive training should be integrated with physical exercises to enhance gait performance, particularly focusing on attention and executive function, as this combination helps older adults apply their training to daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Improve Gait in Older Adults with Cognitive Impairment: A Systematic Review. Zhang, W., Low, LF., Gwynn, JD., et al.[2021]

Home-based virtual reality (VR) exercise is safe and feasible for individuals with mild cognitive impairment, with participants completing 99% of the prescribed sessions over 6 weeks without major adverse events.

While most participants enjoyed the VR program and reported physical benefits, no significant changes were observed in physical or cognitive outcomes after the 6-week intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Home-Based Nonimmersive Virtual Reality to Encourage Physical and Cognitive Exercise in People With Mild Cognitive Impairment: A Feasibility Study. Sheehy, L., Sveistrup, H., Knoefel, F., et al.[2022]

A home-based exercise program with telephonic coaching was developed for older adults with Motoric Cognitive Risk syndrome, showing that this approach is safe and feasible for promoting exercise participation.

The program had no adverse effects, and participants rated it highly, indicating that personalized and supervised exercise can effectively overcome barriers to physical activity in cognitively impaired individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. Ambrose, AF., Gulley, E., Verghese, T., et al.[2021]

A 12-month multifactorial intervention significantly improved mobility-related disability in 241 frail older adults, as evidenced by better scores on the Goal Attainment Scale and Life Space Assessment compared to the control group.

Participants in the intervention group also demonstrated a slight increase in walking speed and higher scores on activity measures, indicating enhanced mobility and participation in daily life activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial. Fairhall, N., Sherrington, C., Kurrle, SE., et al.[2022]

56% of older adults with cognitive impairment without dementia (CIND) were found to be physically inactive, with self-rated health, difficulty walking, total assets, and education level being significant predictors of inactivity.

Despite the high prevalence of inactivity, 61% of inactive participants were capable of engaging in greater moderate-vigorous physical activity (MVPA), suggesting that tailored interventions could enhance their health and cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical inactivity in older adults with cognitive impairment without dementia: room for improvement. Miller, MJ., Cenzer, I., Barnes, DE., et al.[2023]

A pilot study involving 25 older adults with mild to moderate cognitive impairment demonstrated that using a prompting device significantly reduced sedentary behavior and increased light walking, with over 70% of participants adhering to the activity regimen.

The intervention not only improved physical activity levels but also showed significant positive effects on cognitive function, physical function, and quality of life, indicating its potential as a beneficial strategy in assisted living settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REducing SEDENTary Behavior Among Mild to Moderate Cognitively Impaired Assisted Living Residents: A Pilot Randomized Controlled Trial (RESEDENT Study). Dillon, K., Prapavessis, H.[2022]

Exercise-based therapy can potentially improve health for individuals with Mild Cognitive Impairment (MCI) or dementia, but adherence to these exercise programs is a significant challenge.

Fifteen different strategies were evaluated to support adherence, with music being the only strategy shown to be effective in a comparative design, but only for those already interested in activities, highlighting the need for more robust evidence on adherence strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence support strategies for exercise interventions in people with mild cognitive impairment and dementia: A systematic review. van der Wardt, V., Hancox, J., Gondek, D., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39283901/

The OASIS walking study-Older adults with cognitive ...

Efficacy outcomes will be measured before the start of the intervention, after 3 weeks of the intervention, and immediately after 6-week ...

2.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0308268

The OASIS walking study—Older adults with cognitive ...

Efficacy outcomes will be measured before the start of the intervention, after 3 weeks of the intervention, and immediately after 6-week ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11404812/

The OASIS walking study—Older adults with cognitive ...

This study had the highest recruitment and adherence rates, monitored intervention fidelity, and resulted in a significant improvement to all outcomes ( ...

4.

researchgate.net

researchgate.net/publication/384067767_The_OASIS_walking_study-Older_adults_with_cognitive_impairment_performing_sit_to_stands_and_walking_in_transitional_care_programs_Protocol_for_a_feasibility_study

(PDF) The OASIS walking study—Older adults with ...

Residents (n = 25) showed significant improvements after the intervention: Timed Up-and-Go (-8.85 seconds, p = .00), Two-Minute Walk Test (27.47 ...

5.

withpower.com

withpower.com/trial/phase-delirium-10-2023-7a4d2

Walking Intervention for Cognitive Impairment (OASIS Trial)

What data supports the effectiveness of the OASIS Walking Intervention treatment for cognitive impairment? ... cognitive outcomes after the 6-week intervention.