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

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

What data supports the effectiveness of the treatment Green Activity Program for Dementia?

Research shows that regular exercise can improve mood, health, and quality of life for people with dementia. Programs like the tailored activity program and home exercise interventions have been effective in reducing symptoms and improving well-being in dementia patients. ^{1 2 3 4 5}

Is the Green Activity Program for Dementia safe for humans?

The Seniors Exercise Park program, similar to the Green Activity Program, was found to be safe for people with dementia, with no falls or adverse events reported during a 12-week study. Participants enjoyed the program, and it was feasible with proper supervision and individualized communication. ^{6 7 8 9 10}

How is the Green Activity Program for Dementia different from other treatments for dementia?

The Green Activity Program for Dementia is unique because it focuses on prescribing nature-based activities, which may include gardening and other outdoor exercises, to improve the quality of life for people with dementia. This approach is different from traditional treatments that often emphasize medication or indoor physical activities. ^{3 5 8 11 12}

What is the purpose of this trial?

The purpose of this study is to test the Green Activity Program that was designed with people living with memory challenges and their study partners to see if it can be done and if they enjoy the program. "Green activities" are nature activities that the person enjoys and can be done with other people or pets. For example, dog walking, hiking, outdoor yoga, and gardening are all green activities. The purpose of the program is to help people living with memory challenges participate in nature activities they enjoy. The goal of the program is to help people stay active and improve their health and well-being.

Research Team

Rebecca Lassell, PhD

Principal Investigator

Indiana Unversity

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

The impact of dementia on rehabilitation outcomes following hip fracture. [2023]

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

Effects of continuous activity programming on behavioral symptoms of dementia. [2019]

4. England 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. [2020]

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

A home health care approach to exercise for persons with Alzheimer's disease. [2019]

6. England 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. [2023]

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

The Applicability of a High-Intensity Functional Exercise Program Among Older People With Dementia Living in Nursing Homes. [2020]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Attending an activity center: positive experiences of a group of home-dwelling persons with early-stage dementia. [2018]

9. England 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. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

Evaluation of an implementation project: The exercise physiology in aged care program. [2020]

11. England pubmed.ncbi.nlm.nih.gov

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

12. England 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. [2021]