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

Trial Summary

What is the purpose of this trial?

The I-COACH study will focus on seniors with mental health conditions who are living in senior community housing. This initiative proposes to assess the feasibility and acceptability of a 12-week integrated program of cognitive remediation (CR) in combination with social and physical activity using an open-label design. The program will be provided over three iterative groups of six participants each, with one Personal Support Worker (PSW). The program will be co-designed at a granular level in an iterative process, drawing upon feedback provided by each participant group, PSW, and community housing staff to improve the user experience. We will build the capacity for community personal support workers (PSWs) to deliver this program independently and with fidelity to the intervention model. Our ultimate goal is to help seniors continue to live as long as possible in their homes within the community.

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 data supports the effectiveness of the I-COACH program treatment for aging-related mental health challenges?

Research shows that combining mental, physical, and social activities can improve brain function and cognitive performance in older adults. Studies found that such combined interventions can lead to better memory, attention, and overall cognitive health, suggesting that the I-COACH program may be effective for aging-related mental health challenges. ^{1 2 3 4 5}

Is the Integrated Cognitive and Physical Activities program safe for older adults?

Research indicates that home-based exercise programs, which include cognitive and physical activities, are safe for older adults, even those at high risk for dementia. In a study with older adults, no adverse effects were reported, and the program was well-received. ^{2 6 7 8 9}

How is the I-COACH treatment different from other treatments for aging-related mental health challenges?

The I-COACH program is unique because it combines cognitive exercises, physical activity, and social engagement into a single integrated treatment, aiming to improve both mental and physical health in older adults, unlike other treatments that typically focus on just one aspect. ^{9 10 11 12 13}

Research Team

Angela Golas, MD

Principal Investigator

Center for Addiction and Mental Health

Eligibility Criteria

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

My gender identity does not limit my participation.

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

Exclusion Criteria

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

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

Timeline

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Combined cognitive-psychological-physical intervention induces reorganization of intrinsic functional brain architecture in older adults. [2022]

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

A rehabilitation program for Alzheimer's disease. [2015]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Exercise with Multicomponent Cognitive Intervention for Older Adults with Alzheimer's Disease: A 6-Month Randomized Controlled Trial. [2020]

4. Switzerland 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. [2020]

5. England 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

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

Interactive Effects of Physical Activity and Cognitive Activity on Cognition in Older Adults Without Mild Cognitive Impairment or Dementia. [2021]

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

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

9. England pubmed.ncbi.nlm.nih.gov

A cross-sectional survey of a public, evidence-based multimodal program for cognitive health in older adults. [2021]

10. England 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'. [2022]

11. United States 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. [2021]

12. Switzerland 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. [2022]

13. Sweden pubmed.ncbi.nlm.nih.gov

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