Clinical trial NCT06466460: Motion-based Interactive Technology for Improved Quality of Life in Individuals With Cognitive Impairment
Official title: Motion-based Interactive Technology for Improved Quality of Life in Individuals With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Cognitive Impairment
Keywords: interactive technology
quality of life
motion based
intervention
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Region Örebro County
First posted: 2024-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 Few nursing homes have used this method, but a pilot project (unpublished) at nursing home for people with dementia, the investigators observed positive effects on the residents' quality of life.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?

Detailed description: The project includes two studies;

Study 1) The Intervention Study

A Randomized Controlled Trial (RCT) study with a quantitative design. Approximately 60-80 people will be included in the intervention study and randomized into either the intervention group or the control group. The cycling intervention involves cycling twice a week for 8 weeks, with each session lasting about 40 minutes.The intervention will be carried out at the nursing home where the participant resides.

Measurement instruments will be used where participants will answer questions and perform physical tests. Observation instruments and questionnaires with questions concerning the participants will be answered by residential staff and research assistants. Information regarding necessary medications and Body mass index will be obtained from the participants' health and medical records from the municipality.

Analysis Pre- and post-measurements will be conducted.The results from the measurements will be statistically analyzed and the outcomes compared between the intervention group and the control group. The results will be analyzed according to the intention-to-treat principle, meaning that all participants' results will be analyzed regardless of whether they completed the intervention or not. The results will also be analyzed per protocol, meaning that only individuals who completed the intervention (16 cycling sessions) will be included in the analysis.

Description of the Virtual Cycling Intervention The intervention to be carried out involves the participant cycling on a stationary bike while an interactive film plays on a large-screen Television. The films allow the participant to cycle through various landscapes, cities, etc., and the participant can choose the film based on their previous experiences and interests, to create a motivating activity. Participants will perform the activity individually, together with a research assistant. The research assistant is a specialist nurse assistant (specially trained in the field of dementia or welfare technology) who is well-versed in working with people with dementia and works daily with this client group. The research assistant will be active during the activity and stimulate the participant to talk about what they see and experience while cycling to enhance the participant's cognitive and social activity abilities.

Study 2) The Interview Study

After the intervention (study 1) is completed, a qualitative study will be conducted using semi-structured interviews with residential staff and research assistants. The interview guide includes questions about participants' daily activities before, during, and after the intervention, changes in quality of life, participants' experiences of the intervention, and thoughts on using the virtual bike in the residence. Approximately 25-30 residential staff/research assistants are planned to be interviewed until saturation is reached. All interviews will be conducted by a doctoral student and will take about 45 minutes each. The interviews will be recorded and transcribed verbatim.The interviews with the residential staff will take place approximately 2-4 weeks after the end of the cycling intervention. The research assistants will be interviewed approximately 2-4 weeks after all cycling interventions have been completed.

Analysis The interviews and questionnaire responses will be analyzed inductively, where meaning units, condensed meaning units, codes, and categories form themes that describe the entire material. The themes will be illustrated with quotes. The analyses will be conducted using the software NVivo 12. Some of the interviewed participants will be selected to discuss the analyzed results with the doctoral student and a researcher at one occasion. This procedure increases the validity of the interview study.

Eligibility criteria: Study 1)

Inclusion Criteria:

* age more than 65
* resides in a nursing home
* cognitive impairment measured by MMSE, scoring \<24 points on the MMSE.

Exclusion Criteria:

* Individuals who cannot provide their own informed consent will be excluded, in consultation with their relatives/guardians.
* Individuals who cannot do the movement to the cycle

Study 2)

Inclusion Criteria:

* no age limits
* the residential staff should have worked closely with the participant in the intervention study for three months before the intervention began.
* the residential staff should have worked closely with the participant during the duration of the intervention study (16 sessions).
* the residential staff should have participated once when the participant conducted the cycling intervention, as the staff member being interviewed.

Exclusion Criteria:

- residential staff who are not assessed to understand and speak Swedish to an extent that allows the interview to be conducted will be excluded.

Primary outcomes:
measure: Quality of life- Quality of Life in Late-Stage Dementia
timeFrame: 10 weeks
Secondary outcomes:
measure: Quality of life- EuroQol-5 Dimensions-5 Levels
timeFrame: 10 weeks
measure: Behavioral and psychological symptoms- The Neuropsychiatric Inventory
timeFrame: 10 weeks
measure: Physical test- The Timed Chair Stand Test
timeFrame: 10 weeks
measure: Physical test- The Timed Up and Go
timeFrame: 10 weeks
measure: Cognitive test- The Mini-Mental State Examination
timeFrame: 10 weeks
Other outcomes:
measure: Use of medication
timeFrame: 12 weeks
measure: Health data- Body Mass Index
timeFrame: 10 weeks
Locations:
Study officials:
affiliation: Örebro University, Sweden
name: Marie Matérne
role: PRINCIPAL_INVESTIGATOR
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