Motion-based Interactive Technology for Improved Quality of Life in Individuals With Cognitive Impairment

NCT ID: NCT06466460

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2029-12-31

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 Few nursing homes have used this method, but a pilot project (unpublished) at nursing home for people with dementia, the investigators observed positive effects on the residents' quality of life.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

Conditions

Dementia; Cognitive Impairment

Study Design

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

Study Groups

Motion based intervention

To examine whether the activity of virtual cycling contributes to the improvement of quality of life for individuals with cognitive impairment

Group Type: EXPERIMENTAL

Motion based - Virtual cycling

Intervention Type: OTHER

To examine whether the activity of virtual cycling contributes to the improvement of quality of life for individuals with cognitive impairment. (Intervention study)

No intervention

no intervention for this group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motion based - Virtual cycling

To examine whether the activity of virtual cycling contributes to the improvement of quality of life for individuals with cognitive impairment. (Intervention study)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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)

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Örebro County

OTHER

Sponsor Role: collaborator

Marie Matérne

OTHER

Sponsor Role: lead

Responsible Party

Marie Matérne

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marie Matérne

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

School of behavioural, social and legal sciences

Örebro, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Marie Matérne, PhD

Role: CONTACT

marie.materne@oru.se

+46707961388

Alexandra Björck, Master

Role: CONTACT

alexandra.bjorck@oru.se

+4619586943

Facility Contacts

Alexandra M Bjorck, Master

Role: primary

alexandra.bjorck@oru.se

+4619586943 ext. +46

References

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Other Identifiers

Wake it _OrebroU

Identifier Type: -

Identifier Source: org_study_id