Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466460
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-06-07
Brief Title:
Motion-based Interactive Technology for Improved Quality of Life in Individuals With Cognitive Impairment
Sponsor:
Örebro University Sweden
Organization:
Örebro University Sweden
Study Overview
Official Title:
Motion-based Interactive Technology for Improved Quality of Life in Individuals With Cognitive Impairment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WakeIT
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 80000 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method for older adults with cognitive impairments Few nursing homes have used this method but a pilot project unpublished at nursing home for people with dementia the investigators observed positive effects on the residents quality of life Virtual cycling has only been evaluated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 projects 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
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 projects 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 minutesThe 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 conductedThe 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 participants 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 staffresearch 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 verbatimThe 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
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 minutesThe 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 conductedThe 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 participants 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 staffresearch 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 verbatimThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None