Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training

NCT ID: NCT04539132

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-10-31

Brief Summary

Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease all represent a range of degenerative conditions that have cognitive impairments which all limit the ability for older individuals to self-manage care, participate in daily activities and community participation. The consequences of these progressive diseases increase the requirement for residential care, associated medical costs and may negatively impact the overall quality of life and mental health for individuals. According to the Alzheimer Society of Canada, over the next few decades, more than 1 million Canadian's will be living with decreased cognitive ability and will require an increased amount of support, whether through family or institutional sources.

Currently, there are few cognitive programs for individuals diagnosed with mild cognitive impairment or for individuals wishing to maintain their current level of cognitive ability which translates to meaningful improvements in daily living and independence, as well as generalized intelligence. To date, the Watson Centre Society for Brain Health (WCSBH) has successfully improved cognitive capacity, executive function and quality of life for over 100 individuals following a wide range of brain injury, and currently has a 77% return to work rate following completion of the full program. The program includes a combination of physical exercise, cognitive training and mindfulness meditation.

The purpose of the research study is to explore the impact of an interdisciplinary cognitive rehabilitation program has upon the cognitive functioning and quality of life for individuals who are assessed to have mild cognitive impairment (MCI). In particular, the aims of this study include: 1) To evaluate changes in cognition and quality life in older adults with MCI. 2) To explore the potential for intensive cognitive intervention in slowing cognitive degeneration in older adults with MCI.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

The "intervention group" will participate in the 6-month interdisciplinary comprehensive rehabilitation program. The ABI Wellness (ABIW) program aimed at this population would be 7 hours a week (2 days per week will be scheduled for the intervention group), consisting of around 4 hours of cognitive training (through specified drills, cognitive exercises focused on executive functioning), 1 hour of physical exercise, 1 hour of mindfulness sessions (meditation) and scheduled break times.

Group Type: EXPERIMENTAL

ABI Wellness Program

Intervention Type: BEHAVIORAL

The ABI Wellness program includes a computerized task which will be completed by all participants remotely. The exercise is a sustained visual-spatial processing task of progressively increasing difficulty. Subjects are presented with an analog clock face, initially showing only one hand. The subject uses a keyboard to enter a value for the hour shown. Feedback on the computer screen indicates whether the response is correct or incorrect. If the response was incorrect, the subject continues to respond until the correct response is entered. After this, a new clock face is shown. Once subjects reach a criterion of 90% accuracy over a series of consecutive responses, an additional hand is added to the clock face. Participants will complete the program at home, online, and will be required to be present on a video call during the exercise with the other participants and research assistants. The program is 150 hours over 6 months, through twice weekly 3-hour sessions.

Control Group

The "non-intervention" group or control group will have all the same pre-tests administered as the intervention group, however, will not participate in the cognitive program. The control group will be required to complete the assessment periods only, however, keep a record of their daily activities in a log format which is presented in the materials included herein. No other intervention or programming will be provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ABI Wellness Program

The ABI Wellness program includes a computerized task which will be completed by all participants remotely. The exercise is a sustained visual-spatial processing task of progressively increasing difficulty. Subjects are presented with an analog clock face, initially showing only one hand. The subject uses a keyboard to enter a value for the hour shown. Feedback on the computer screen indicates whether the response is correct or incorrect. If the response was incorrect, the subject continues to respond until the correct response is entered. After this, a new clock face is shown. Once subjects reach a criterion of 90% accuracy over a series of consecutive responses, an additional hand is added to the clock face. Participants will complete the program at home, online, and will be required to be present on a video call during the exercise with the other participants and research assistants. The program is 150 hours over 6 months, through twice weekly 3-hour sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• T-MoCA score between 19 - 23

Exclusion Criteria

• Potential participants are under the age of 65 years at the time of screening
• Scoring results in a range outside of 19-23 on the MoCA
• Those who have have a diagnosed illness or diagnosed injury which is known to directly and negatively impact cognition
• Are known (legally) to be deemed incapable; unable to appreciate information that is relevant to making decisions or is unable to appreciate the reasonably foreseeable consequences of either making or not making a decision.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Aging and Brain Health Innovation

OTHER

Sponsor Role: collaborator

ABI Wellness Inc

UNKNOWN

Sponsor Role: collaborator

Watson Centre Society for Brain Health

UNKNOWN

Sponsor Role: collaborator

Kwantlen Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tess Kroeker, PhD

Role: PRINCIPAL_INVESTIGATOR

Kwantlen Polytechnic University

Shaun Porter, MSc

Role: STUDY_DIRECTOR

ABI Wellness Inc

Central Contacts

Tess Kroeker, PhD

Role: CONTACT

Tess.Kroeker@kpu.ca

7788778050

Shaun Porter, MSc

Role: CONTACT

sporter@abiwellness.com

1-833-414-8958 ext. 702

Other Identifiers

103298

Identifier Type: -

Identifier Source: org_study_id