Green Activity Program for Dementia

(GAP Trial)

Overseen By Triana Pena

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Heart disease, Cancer, Head injury, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Green Activity Program, which encourages individuals with memory challenges to engage in enjoyable nature activities, such as dog walking or gardening. The goal is to determine if participants find the program enjoyable and if it helps them stay active, potentially improving their overall health and well-being. The trial suits individuals aged 45 and older who have memory challenges and can use a phone. Participants also need a study partner and may collaborate with outdoor activity professionals. As an unphased trial, this study offers a unique opportunity to explore enjoyable activities that may enhance well-being.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Green Activity Program is safe for people living with memory challenges?

Research shows that the Green Activity Program (GAP) is safe and enjoyable for people with memory challenges. In past studies, participants engaged in similar nature activities, such as dog walking, hiking, and gardening, reported feeling better and more relaxed. These activities are generally easy to do and carry little risk.

While specific information on negative effects is lacking, the program includes low-impact activities known to boost well-being, suggesting its likely safety for participants. GAP aims to help people stay active and improve their health, supporting both physical and mental well-being.

Previous studies have demonstrated that these activities are not only doable but also enjoyable, indicating the program's likely safety and benefit for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Green Activity Program for dementia because it offers a refreshing approach by integrating nature-based therapies with personalized coaching. Unlike traditional treatments that often focus on medications, this program emphasizes outdoor activities with tailored strategies to engage people living with memory loss. It combines evaluations of outdoor spaces for safety, personalized goal-setting, and strategy training to promote mental well-being through nature. This holistic and interactive approach aims to enhance quality of life, providing a promising alternative or complement to current treatment options.

What evidence suggests that the Green Activity Program is effective for dementia?

Research shows that spending time in nature can improve well-being and may help with memory issues. The Green Activity Program, which participants in this trial will experience, was created with input from individuals facing memory challenges and aims to keep participants active and healthy. Early results suggest that program participants feel better when engaging in outdoor activities like gardening or walking a dog. These activities are enjoyable and can enhance mood and quality of life for people with memory problems. While researchers continue to study the long-term effects, this approach leverages nature's positive impact on mental health. ^{1 4 6 7 8}

Who Is on the Research Team?

Rebecca Lassell, PhD

Principal Investigator

Indiana Unversity

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino individuals aged 60 or older with memory challenges, such as mild cognitive impairment or early-stage dementia. Participants must speak Spanish or English, be able to use a phone, and have a trusted study partner willing to join them in the program.

Inclusion Criteria

I am 60 years old or older.

My memory and thinking test score is between 13 and 19.

I can make and receive calls on a phone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

GAP-H 12-week Intervention for People Living with Memory Loss & Study Partners involves an OT evaluation, goal-setting, coaching and strategy training over 4-8 in-person sessions for 30-90 minutes each over 12 weeks, with 2 phone or virtual check-ins for 15-30 minutes.

12 weeks

4-8 in-person sessions, 2 phone or virtual check-ins

Follow-up

Participants are monitored for sustained behavior change and program feedback is collected through brief phone interviews.

4 weeks

Phone interviews

What Are the Treatments Tested in This Trial?

Interventions

• Green Activity Program

Trial Overview The Green Activity Program is being tested for its feasibility and enjoyment among participants. It involves nature-related activities like dog walking, hiking, outdoor yoga, and gardening aimed at improving activity levels and overall well-being.

How Is the Trial Designed?

Group I: Single arm pre/post study Experimental Treatment 1 Intervention

GAP 12-week Intervention for People Living with Memory Loss \& Study Partners involves an evaluation, goal-setting, coaching and strategy training over 4-8 virtual or phone sessions for 30-90 minutes each over 12 weeks, with 2 phone or virtual check-ins for 15-30 minutes. GAP Intervention Outdoor Activity Professionals involves a site-evaluation (Accessibility, Fall risk) and education on Dementia Training, SMART Goal setting, Strategy Training for Tailoring Nature Activities, and Behavioral Activation strategies with support from the OT.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

American Federation for Aging Research

Collaborator

Trials

9

Recruited

2,500+

Published Research Related to This Trial

In an observational study involving 90 veterans with dementia, continuous activity programming led to increased engagement in activities, reduced use of psychotropic medications, improved nutrition, and higher family satisfaction without needing extra staff.

When additional staff were available, more intensive activity programming further decreased agitation and improved sleep quality, suggesting that while benefits can be achieved without staffing changes, having more staff enhances the positive effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of continuous activity programming on behavioral symptoms of dementia. Volicer, L., Simard, J., Pupa, JH., et al.[2019]

The Dementia Actif program, which offers various physical and social activities for people living with dementia and their carers, has shown positive impacts on wellbeing and social interaction, suggesting it can help reduce the need for more intensive care services.

The evaluation highlighted the importance of community-based resources in supporting both individuals with dementia and their unpaid carers, although the findings are based on a small sample size, which may limit their generalizability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Dementia Actif, a dementia-friendly exercise and wellbeing programme: mixed-methods study. Davies, CT.[2023]

The DAPA study is a randomized trial aimed at improving cognition in over 800,000 people with dementia in the UK through a structured exercise program that includes both aerobic and resistance training for 4 months.

The intervention consists of supervised exercise classes twice a week, followed by independent exercise, and incorporates behavior modification techniques to enhance effectiveness and cost-effectiveness within the UK National Health Service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an exercise intervention to improve cognition in people with mild to moderate dementia: Dementia And Physical Activity (DAPA) Trial, registration ISRCTN32612072. Brown, D., Spanjers, K., Atherton, N., et al.[2021]

The Seniors Exercise Park program was found to be safe and feasible for older adults living with dementia, with 88% of participants completing the 12-week program and no adverse events reported.

Participants reported high levels of engagement, enjoyment, and positive mood throughout the program, indicating that individualized communication and adjustments were effective in maintaining motivation and participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interveNtion outdoor proJect in the cOmmunitY - results from the ENJOY program for independence in dementia: a feasibility pilot randomised controlled trial. Levinger, P., Goh, AMY., Dunn, J., et al.[2023]

A 12-week exercise program led by an Accredited Exercise Physiologist helped maintain physical function in vulnerable older adults with dementia, as evidenced by improvements in timed-up-and-go and handgrip strength assessments.

Family members and care staff reported positive perceptions of the program's impact, believing that most residents, except those with severe decline, could benefit from participation, highlighting the program's potential value in residential aged care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an implementation project: The exercise physiology in aged care program. Parfitt, G., Post, D., Penington, A., et al.[2020]

Patients with dementia who underwent inpatient rehabilitation after a hip fracture showed significantly lower cognitive function and rehabilitation outcomes compared to those without dementia, indicating that dementia impacts recovery effectiveness.

Despite these challenges, patients with dementia had a shorter hospital stay and a higher likelihood of needing discharge to residential aged care facilities or home with carer support, highlighting the importance of tailored post-rehabilitation care for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of dementia on rehabilitation outcomes following hip fracture. Loh, YL., Wicks, J., Alexander, T.[2023]

Home-dwelling individuals with early-stage dementia reported positive experiences from participating in organized physical and social activities at an activity center, highlighting the importance of feeling included and valued.

The study suggests that tailored activities led by nurses and volunteers can significantly enhance the health and well-being of people with dementia, emphasizing the need for municipalities to support such initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attending an activity center: positive experiences of a group of home-dwelling persons with early-stage dementia. Söderhamn, U., Aasgaard, L., Landmark, B.[2018]

The tailored activity program-outpatient version (TAP-O) significantly reduced neuropsychiatric symptoms (NPS) such as hallucinations, agitation, anxiety, aggression, sleep disorders, and aberrant motor behavior in patients with dementia, compared to a control group receiving psychoeducation.

TAP-O also effectively decreased caregiver burden, indicating it is a beneficial nonpharmacological intervention for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention to reduce neuropsychiatric symptoms and caregiver burden in dementia: Preliminary results from a randomized trial of the tailored activity program-outpatient version. de Oliveira, AM., Radanovic, M., Homem de Mello, PC., et al.[2020]

Regular exercise is crucial for preventive health care, especially for older adults, as it can reduce the risk of chronic illnesses and improve mood and cognitive function.

The RDAD program, a home health exercise and problem-solving intervention, has been shown to effectively decrease physical, psychological, and behavioral disabilities in individuals with dementia, highlighting the importance of making exercise accessible and enjoyable for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home health care approach to exercise for persons with Alzheimer's disease. Logsdon, RG., McCurry, SM., Teri, L.[2019]

A high-intensity functional exercise program was successfully implemented in nursing homes for 93 people with dementia, achieving a median attendance rate of 82.5% and high exercise intensity during sessions.

While the program was generally safe with only minor adverse events reported, factors like low motivation and behavioral symptoms of dementia were identified as barriers to participation and intensity, highlighting the need for strategies to enhance engagement in exercise among this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Applicability of a High-Intensity Functional Exercise Program Among Older People With Dementia Living in Nursing Homes. Sondell, A., Rosendahl, E., Gustafson, Y., et al.[2020]

The Seniors Exercise Park program, designed for older adults, is being tested for its feasibility and potential benefits in improving mobility, independence, and quality of life for individuals with mild to moderate dementia in a residential aged-care setting.

This pilot study will assess the safety and effectiveness of a 12-week structured physical activity program, followed by a maintenance phase, with a focus on recruitment, retention, and adherence among 12 participants per group, aiming to inform future dementia-friendly environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interveNtion outdoor proJect in the cOmmunitY-ENJOY program for independence in dementia: a feasibility pilot randomised controlled trial study protocol. Levinger, P., Goh, AMY., Dunn, J., et al.[2022]

The PrAISED intervention, which involved up to 50 therapy sessions focusing on exercise and functional activities for adults with early dementia or mild cognitive impairment, did not show significant improvements in daily living activities, physical activity, or quality of life compared to usual care after 12 months.

Although the intervention group experienced fewer falls (79 falls) compared to the control group (200 falls), the difference was not statistically significant, indicating that the exercise program did not effectively reduce fall risk or improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. Harwood, RH., Goldberg, SE., Brand, A., et al.[2023]

Citations

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“When she goes out, she feels better:” co-designing a Green ... We sought to co-design a 12-week Green Activity Program (GAP) with Hispanic/Latino individuals living with memory challenges and their care partners.

2. academic.oup.com academic.oup.com/innovateage/article/7/Supplement_1/723/7490118

A GREEN ACTIVITY PRESCRIPTION PROGRAM FOR ... A GREEN ACTIVITY PRESCRIPTION PROGRAM FOR CHINESE AMERICANS LIVING WITH DEMENTIA Open Access. Hayley Belli ,.

3. researchgate.net researchgate.net/publication/376729058_CO-DESIGNING_A_GREEN_ACTIVITY_PRESCRIPTION_PROGRAM_WITH_HISPANICLATINO_PERSONS_LIVING_WITH_MEMORY_CHALLENGES

co-designing a green activity prescription program with ... Nature activities can improve well-being and may modify risk factors for cognitive decline. There is a gap between nature activities offered ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38957542/

"When she goes out, she feels better:" co-designing a ... We sought to co-design a 12-week Green Activity Program (GAP) with Hispanic/Latino individuals living with memory challenges and their care partners.

5. neurologylive.com neurologylive.com/view/applying-innovation-biodesign-framework-promote-equity-an-green-activity-in-dementia-care

Applying the Innovation Biodesign Framework to Promote ... To address this gap, the Green Activity Program was designed to meet the preferences and needs of Hispanic/Latino community members with memory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10738612/

A GREEN ACTIVITY PRESCRIPTION PROGRAM FOR ... A GREEN ACTIVITY PRESCRIPTION PROGRAM FOR CHINESE AMERICANS LIVING WITH DEMENTIA ... Here we present the study design and implementation outcomes ...

7. researchgate.net researchgate.net/publication/376727551_A_GREEN_ACTIVITY_PRESCRIPTION_PROGRAM_FOR_CHINESE_AMERICANS_LIVING_WITH_DEMENTIA

a green activity prescription program for chinese americans ... GAPs have potential to support the health and well-being of Chinese American PLWD by addressing health inequalities and providing accessible, ...

8. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/2133/green-activity-prescription-program/

A green activity prescription program for Chinese Americans ... This study will iteratively develop and test the feasibility and acceptability of a 12-week green prescription program among Chinese American people living ...