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

January 8, 2026 updated by: Marie Matérne

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 Few nursing homes have used this method, but a pilot project (unpublished) at nursing home for people with dementia, the investigators observed positive effects on the residents' quality of life.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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Örebro, Sweden, 70182
        • Recruiting
        • School of behavioural, social and legal sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motion based intervention
To examine whether the activity of virtual cycling contributes to the improvement of quality of life for individuals with cognitive impairment
Other: 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)
No Intervention: No intervention
no intervention for this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life- Quality of Life in Late-Stage Dementia
Time Frame: 10 weeks
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

Outcome Measure
Measure Description
Time Frame
Quality of life- EuroQol-5 Dimensions-5 Levels
Time Frame: 10 weeks

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
Time Frame: 10 weeks

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
Time Frame: 10 weeks

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
Time Frame: 10 weeks

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
Time Frame: 10 weeks

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

Outcome Measure
Measure Description
Time Frame
Use of medication
Time Frame: 12 weeks
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
Time Frame: 10 weeks
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
Number of falls
Time Frame: 24 weeks
Information gather from medical records regarding the number of times the participants of this study has fallen within the two months before and after the intervention.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marie Matérne

Collaborators

Region Örebro County

Investigators

  • Principal Investigator: Marie Matérne, Örebro University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Wake it _OrebroU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We could share on other researchers request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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