Cognitive & Physical Activities for Aging-related Mental Health Challenges

(I-COACH Trial)

Overseen By Dewi Clark, MHSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Active substance use, profound cognitive impairment

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a 12-week program designed to help seniors in community housing with mental health challenges. It combines cognitive exercises, physical activities, and social interactions to boost brain function and reduce loneliness. Researchers will use participant feedback to refine the program for better results. This trial suits seniors with mental health conditions who are stable (no recent psychiatric hospital stays or medication changes) and can understand English. Participants should be able to read newspaper headlines and hear conversations clearly.

As an unphased trial, this study offers seniors a unique opportunity to contribute to innovative mental health solutions tailored to their needs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be clinically stable, which means no changes in your psychotropic medication dosage in the 4 weeks before joining the study.

What prior data suggests that this program is safe for seniors with mental health conditions?

Research has shown that combining physical activities with brain exercises benefits older adults. One study found that these programs improve mental skills, such as memory and focus, while also enhancing physical health by improving balance and lowering blood pressure. Another study demonstrated that exercise benefits both the body and mind of seniors with conditions like dementia.

Importantly, seniors usually tolerate these activities well. Although specific side effects weren't mentioned, the absence of reports about serious problems suggests that this combined approach is safe. This makes the program a promising choice for seniors who want to improve their well-being and remain active in their communities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this integrated program because it offers a holistic approach to improving mental health in aging populations. Unlike standard treatments that often focus solely on medication or traditional therapy, this program combines cognitive remediation, physical exercise, and socially stimulating activities. This multifaceted approach not only aims to enhance brain function but also promotes physical health and social engagement, tackling mental health from multiple angles. By integrating these elements, it has the potential to provide more comprehensive benefits, improving overall well-being and reducing the risk of isolation in older adults.

What evidence suggests that the Integrated Cognitive Remediation and Physical Exercise Program is effective for aging-related mental health challenges?

This trial will evaluate an integrated program of cognitive remediation, physical exercise, and socially stimulating activity. Research has shown that combining mental exercises with physical activity can improve brain function in seniors. Studies have found that these programs enhance memory, focus, and overall thinking skills. Including physical activity also builds strength and reduces sedentary time. Social activities in the program boost well-being and lessen loneliness. Overall, this approach may help seniors live more independently and maintain better mental health. ^{3 6 7 8 9}

Who Is on the Research Team?

Angela Golas, MD

Principal Investigator

Center for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for older adults over 50 living in community housing with mental health conditions, who speak English and are clinically stable. They must be able to see and hear well enough to participate. Those with profound cognitive impairment or recent substance use issues cannot join.

Inclusion Criteria

Meets DSM-V criteria for any disorder

Clinically stable as operationalized by (1) having not been admitted to a psychiatric hospital within the 3 months prior to assessment, (2) having had no change in psychotropic medication dosage within the 4 weeks prior to assessment, and (3) ascertained to be clinically and medically stable by one the study psychiatrists

My gender identity does not limit my participation.

Exclusion Criteria

Meets diagnostic criteria for active substance use or dependence within the 6 months prior to the initial assessment except for caffeine or nicotine

Has profound cognitive impairment that, in the opinion of the PI, precludes benefit from CR and therefore study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline neuropsychological assessment

1 week

1 visit (in-person)

Treatment

Participants engage in a 12-week integrated program of cognitive remediation, physical exercise, and socially stimulating activities

12 weeks

4 visits per week (in-person)

Follow-up

Participants complete satisfaction surveys and semi-structured interviews to provide feedback on the program

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Integrated program of cognitive remediation, physical exercise and socially stimulating activity

Trial Overview

The study tests a 12-week program combining cognitive exercises, physical activity, and social interaction for seniors with mental illness. It's an open-label design where feedback from participants helps refine the program.

How Is the Trial Designed?

Group I: Integrated program of cognitive remediation, physical exercise and socially- stimulating activity Experimental Treatment 1 Intervention

Cognitive Remediation (CR) is a well-established intervention that aims to improve neurocognitive abilities (such as memory performance, executive functioning, processing speed, and attention) using four techniques: didactic teaching, computerized drills, in-class strategic monitoring and discussions of the generalization of cognitive skills to daily life. The physical exercise component consists of physical activities designed for the geriatric population that aim to reduce sedentary behaviors while increasing social engagement. The socially stimulating activity aim to decrease social isolation, improve well-being, community connection and rapport. The integrated, 12-week, group-based program consists of CR 1h/day, 2 days/week, 30min of physical exercises 1day/week and 1h of socially stimulating activities 1day/week

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

LOFT Community Services

Collaborator

Trials

4

Recruited

490+

LOFT Community Services

Collaborator

Published Research Related to This Trial

A 12-month rehabilitation program for 64 participants with mild to moderate Alzheimer's disease significantly improved their physical fitness and quality of life, demonstrating its effectiveness as a complementary therapy.

While the program did not show improvements in cognitive ability, enhancing physical capacity and quality of life could provide important long-term benefits for both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rehabilitation program for Alzheimer's disease. Serdà i Ferrer, BC., del Valle, A.[2015]

In a study of 742 older adults, interactions between physical activity and cognitive activity were found to significantly impact working and semantic memory, suggesting that both types of activities are important for cognitive health.

Higher levels of both physical and cognitive activities at the beginning of the study were linked to better cognitive performance five years later, indicating that maintaining these activities may help prevent cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Effects of Physical Activity and Cognitive Activity on Cognition in Older Adults Without Mild Cognitive Impairment or Dementia. Halloway, S., Schoeny, ME., Wilbur, J., et al.[2021]

This study will investigate the effects of different combinations of cognitive and physical training on cognitive functions and physical fitness in 285 older adults over a 4-month period, with assessments conducted at multiple time points.

The research aims to demonstrate that combined cognitive and physical training will yield greater improvements in health outcomes compared to single training modes or no intervention, potentially benefiting a larger elderly population if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for 'the effects of multimodal training of cognitive and/or physical functions on cognition and physical fitness of older adults: a cluster randomized controlled trial'. Chow, BC., Jiao, J., Man, D., et al.[2022]

Moderate physical activity can positively impact mental health in elderly individuals, enhancing mental activity, satisfaction, and self-respect.

Maintaining physical and social activity is crucial for the elderly, as it helps counteract passivity and supports overall well-being, challenging the outdated theory of disengagement in gerontology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between physical activity and mental factors in the elderly. Ingebretsen, R.[2008]

In a study of 55 healthy older adults, cognitive physical training (CPT) showed significant long-term benefits in overall cognition and verbal long-term memory compared to CPT with counseling, suggesting that combining cognitive and physical activities is effective for maintaining cognitive health.

Predictors of success in CPT included initial low performance in verbal short-term memory and fluency, as well as baseline levels of insulin-like growth factor 1 (IGF-1) and brain-derived neurotrophic factor (BDNF), indicating that individual characteristics can influence the effectiveness of cognitive training interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Cognitive Training With and Without Additional Physical Activity in Healthy Older Adults: A Follow-Up 1 Year After a Randomized Controlled Trial. Kalbe, E., Roheger, M., Paluszak, K., et al.[2020]

A 12-week trial involving 126 sedentary older adults showed that combining mental activities with exercise improved physical function and health-related quality of life (HRQOL), indicating a beneficial approach for those with cognitive complaints.

While different combinations of mental and exercise activities were tested, all groups experienced improvements in physical function measures, suggesting that even light exercise can provide significant benefits for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Activity and eXercise (MAX) trial: Effects on physical function and quality of life among older adults with cognitive complaints. Middleton, LE., Ventura, MI., Santos-Modesitt, W., et al.[2021]

A 12-week aerobic exercise program significantly improved working memory and attention in healthy adults aged 50-70, indicating its efficacy as a cognitive health intervention.

Combining aerobic exercise with computerized cognitive training did not yield additional cognitive benefits, suggesting that aerobic exercise alone is sufficient for enhancing cognitive function in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Aerobic Exercise, Cognitive and Combined Training on Cognition in Physically Inactive Healthy Late-Middle-Aged Adults: The Projecte Moviment Randomized Controlled Trial. Roig-Coll, F., Castells-Sánchez, A., Lamonja-Vicente, N., 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 longitudinal study involving 24 individuals with early-stage Alzheimer's disease showed that participation in a structured exercise program significantly improved physical fitness, including aerobic capacity and strength, with highly significant gains in the six-minute walk test (p < .001).

The program also positively impacted mood and slowed cognitive decline, demonstrating that exercise combined with cognitive and social stimulation can provide meaningful benefits for individuals with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Student-led exercise sessions yield significant fitness gains for Alzheimer's patients. Arkin, SM.[2022]

A new multimodal program called 'brain coach' was developed to support cognitive health in older adults, integrating physical, cognitive, social, mindful, and creative activities, and was tested with 660 participants aged around 71 years.

Participants reported improvements in memory, well-being, and lifestyle habits after engaging with the program for at least 3 months, with positive attitudes towards brain health correlating with these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of a public, evidence-based multimodal program for cognitive health in older adults. Studer-Luethi, B., Brasser, M., Lusti, S., et al.[2021]

A 6-month study involving 33 older adults with moderate to severe Alzheimer's disease showed that combining physical exercise with a multicomponent cognitive program can lead to improvements in cognitive function, particularly as indicated by the ADAS-cog score in secondary analyses.

Participants in the intervention group also demonstrated significant improvements in physical performance measures, suggesting that physical exercise may enhance overall well-being in individuals with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial. Kim, MJ., Han, CW., Min, KY., et al.[2020]

A 6-week combined intervention of cognitive training, Tai Chi, and group counseling significantly improved cognitive performance in healthy older adults, as shown by fMRI results.

The intervention led to changes in brain activity patterns, particularly in areas associated with cognition, indicating that engaging in enriched activities can promote brain plasticity and help maintain cognitive function in aging individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined cognitive-psychological-physical intervention induces reorganization of intrinsic functional brain architecture in older adults. Zheng, Z., Zhu, X., Yin, S., et al.[2022]

The SMART trial will investigate the effects of cognitive training (CT) and progressive resistance training (PRT) on cognitive function and independence in 132 older adults at risk for cognitive decline, using a double-blind, randomized design over 6 months.

This study aims to identify not only the cognitive benefits of these interventions but also their impact on brain health, physical fitness, and overall well-being, potentially revealing mechanisms that contribute to slowing cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Mental Activity and Regular Training (SMART) in at risk individuals: a randomised double blind, sham controlled, longitudinal trial. Gates, NJ., Valenzuela, M., Sachdev, PS., et al.[2022]

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