Walking Intervention for Cognitive Impairment

(OASIS Trial)

Recruiting at 1 trial location

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

Trial Summary

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 data supports the effectiveness of the OASIS Walking Intervention treatment for cognitive impairment?

Research shows that walking programs can help maintain or improve daily activities and slow cognitive decline in people with Alzheimer's and mild cognitive impairment. A study found that a six-month walking program improved daily activities and slowed cognitive decline in Alzheimer's patients, suggesting that regular walking may benefit those with cognitive challenges. ^{1 2 3 4 5}

Is the Walking Intervention for Cognitive Impairment safe for humans?

Research shows that walking interventions, including those using virtual reality or prompting devices, are generally safe for older adults with cognitive impairments. Studies found no major adverse events, and participants were able to complete the programs successfully. ^{1 6 7 8 9}

How is the OASIS Walking Intervention treatment different from other treatments for cognitive impairment?

The OASIS Walking Intervention is unique because it focuses on a structured walking program to help maintain cognitive function and daily living activities in people with cognitive impairment, unlike other treatments that may not emphasize physical activity. This approach is based on evidence that regular walking can improve mobility and slow cognitive decline, particularly in older adults with conditions like Alzheimer's disease. ^{1 2 4 5 10}

What is the purpose of this trial?

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.

Research Team

Katherine S McGilton, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Interventions to Improve Gait in Older Adults with Cognitive Impairment: A Systematic Review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Adherence support strategies for exercise interventions in people with mild cognitive impairment and dementia: A systematic review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Six-month walking program changes cognitive and ADL performance in patients with Alzheimer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a walking program for community-dwelling older adults with mild cognitive impairment. [2019]

6. United States 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Physical inactivity in older adults with cognitive impairment without dementia: room for improvement. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Effect of a multifactorial interdisciplinary intervention on mobility-related disability in frail older people: randomised controlled trial. [2022]