Motion-based Interactive Technology for Improved Quality of Life in Individuals With Cognitive Impairment
NCT Number: NCT06466460
Acronym: WakeIT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dementia|Cognitive Impairment
Interventions: OTHER: Motion based - Virtual cycling
Sponsor: Örebro University, Sweden
Collaborators: Region Örebro County
Sex: ALL
Age: OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-08-20
Completion Date: 2029-12-31

Summary:
The aging population is growing in Sweden and worldwide, highlighting the urgent need to address their needs using available societal resources. In Swedish nursing homes, about 80,000 people reside, 70% of whom have cognitive impairments, and many are physically inactive. Cognitive impairment negatively impacts daily activities and quality of life, and is the most common reason for moving from home to a nursing home. Methods to meet these individuals' needs must be developed to motivate physical, cognitive, and social activation, aiming to improve the quality of life for older people with cognitive impairments.

Movement-based interactive technology is a type of welfare technology that uses a virtual environment to stimulate activity. Virtual cycling is one example, where the individual pedals a stationary bike while watching a self-chosen interactive film. Virtual cycling thus includes multiple elements such as physical activation and cognitive and social stimulation. Previous research has shown virtual cycling to be a promising method for older adults with cognitive impairments. Few nursing homes have used this method, but a pilot project (unpublished) at nursing home for people with dementia, the investigators observed positive effects on the residents' quality of life. Virtual cycling has only been evaluated in three small international research studies, none of which have examined the impact on participants' quality of life. Therefore, the project's aim is to evaluate whether virtual cycling can improve quality of life and the physical, social, and cognitive activity abilities of older people with cognitive impairments.

1. Does virtual cycling contribute to an improved quality of life for older people with cognitive impairment?
2. How do residential staff and research assistants perceive the impact of virtual cycling on the physical, social, and cognitive abilities, as well as the quality of life, of older people with cognitive impairment?
3. What experiences do residential staff and research assistants have regarding the opportunities and obstacles for implementing virtual cycling?

Primary Outcome Measures: Quality of life- Quality of Life in Late-Stage Dementia, Quality of Life in Late-Stage Dementia (QUALID) is a proxy instrument and assesses observable quality of life in dementia. The QUALID includes eleven questions about observed behavior and mood (smiling, appearing sad, crying, irritable, etc.) that assess quality of life in dementia on a five-point Likert scale. The result of the test is scored between 11-55 points, where lower scores indicate a higher quality of life. It will be conducted two times, approximately 1-2 weeks before and after the intervention, for both the treatment group and the control group. The required time for the test is 15 minutes., 10 weeks
Secondary Outcome Measures: Quality of life- EuroQol-5 Dimensions-5 Levels, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) measures quality of life and will be used as both a self-assessment instrument and a proxy instrument. The instrument consists of two parts, with the first part containing five health dimensions: mobility, daily activities, self-care, pain/discomfort, and anxiety/depression. The EQ-5D-5L is an extension of the original EQ-5D with expanded response options, including five statements indicating whether an individual has "no," "slight," "moderate," "severe," or "extremely severe" problems within the dimensions. In the second part of the instrument, the individual's general health is assessed using a visual analog scale (VAS).

It will be conducted two times, approximately 1-2 weeks before and after the intervention, for both the treatment group and the control group. The required time for the test is 15 minutes., 10 weeks|Behavioral and psychological symptoms- The Neuropsychiatric Inventory, The Neuropsychiatric Inventory (NPI) measures behavioral and psychological symptoms through observation in individuals with dementia. Through observations, the presence and severity of 12 symptoms are assessed, such as agitation, depression, anxiety, apathy, and motor restlessness. The instrument rates the presence (Likert scale, 1-4 points) and severity (Likert scale, 0-3 points) of the various symptoms. The frequency and severity scores are multiplied to produce a total score ranging from 0 to 144 points, with higher scores indicating more severe symptoms.

It is a proxy instrument and it will be conducted two times, approximately 1-2 weeks before and after the intervention, for both the treatment group and the control group. The required time for the test is 15 minutes., 10 weeks|Physical test- The Timed Chair Stand Test, The Timed Chair Stand Test (TCST), measures strength in the lower extremities. The participant is to perform ten chair rises from a chair (height 45 cm). The participant must stand up fully and sit down completely each time. The outcome measure is the time in seconds, with a longer time indicating a higher risk of falls in older adults.

It will be conducted two times, approximately 1-2 weeks before and after the intervention, for both the treatment group and the control group. The required time for the test is 15 minutes., 10 weeks|Physical test- The Timed Up and Go, The Timed Up and Go (TUG), assesses and measures mobility and proactive balance. The participant is to rise from a seated position in an armchair, walk 3 meters, turn around, walk back, and sit down. The time taken to complete this task is measured. The outcome measure is the time in seconds, with a longer time indicating a higher risk of falls in older adults.

It will be conducted two times, approximately 1-2 weeks before and after the intervention, for both the treatment group and the control group. The required time for the test is 15 minutes., 10 weeks|Cognitive test- The Mini-Mental State Examination, The Mini-Mental State Examination (MMSE), is a screening instrument for cognitive impairment. The instrument consists of 20 questions (maximum 30 points) and assesses cognitive functions, such as orientation, memory, language, and visuospatial ability. Lower points indicate more cognitive difficulties. Indication of dementia is has cut-off of \<24 points (out of 30 points).

It will be conducted two times, approximately 1-2 weeks before and after the intervention, for both the treatment group and the control group. The required time for the test is 30 minutes., 10 weeks
Other Outcome Measures: Use of medication, Medication that the participant takes to counteract behavioral and psychological symptoms associated with dementia. Information about the quantity of necessary medication taken over a period of one month is collected from the participants health journal before the intervention begins and once after the intervention ends, covering a month's consumption period., 12 weeks|Health data- Body Mass Index, Body Mass Index (BMI) is a measure that calculates whether a person is underweight, normal weight, or overweight. BMI is taken from the participants health journal once before the intervention begins and once after the intervention ends., 10 weeks