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DementiaWakeITNCT06466460

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

A study testing Motion based - Virtual cycling in people with Dementia and Cognitive Impairment, run by Marie Matérne at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia, Cognitive Impairment
What is being tested?
Motion based - Virtual cycling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSweden
Study dates
20 Sep 2024to 31 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marie Matérne, PhD contact

+46707961388

marie.materne@oru.se

Alexandra Björck, Master contact

+4619586943

alexandra.bjorck@oru.se

Sweden1 site, 1 recruiting
  • School of behavioural, social and legal sciences

    Örebro, 70182

    Alexandra M Bjorck, Master, +4619586943 ext. +46, alexandra.bjorck@oru.se

    Recruiting

Other trials in Sweden

About this study

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?
Read the 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.

Being tested
Motion based - Virtual cycling
Keywords
interactive technology, quality of life, motion based, intervention
Medical subject headings
Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motion based - Virtual cyclingOther

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

Study groups in NCT06466460
Study groupRoleWhat they receive
Motion based interventionExperimentalTo examine whether the activity of virtual cycling contributes to the improvement of quality of life for individuals with cognitive impairment
Receives: Other: Motion based - Virtual cycling
No interventionNo interventionno intervention for this group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 weeks

Secondary outcomes (5)
  1. 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.

    Measured: 10 weeks

  2. 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.

    Measured: 10 weeks

  3. 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.

    Measured: 10 weeks

  4. 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.

    Measured: 10 weeks

  5. 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.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start20 Sep 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466460
Sponsor's protocol ID
Wake it _OrebroU
Acronym
WakeIT
Status last verified
Jan 2026
First submitted
7 Jun 2024
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We could share on other researchers request.

Publications

  • de Souto Barreto P, Morley JE, Chodzko-Zajko W, H Pitkala K, Weening-Djiksterhuis E, Rodriguez-Manas L, Barbagallo M, Rosendahl E, Sinclair A, Landi F, Izquierdo M, Vellas B, Rolland Y; International Association of Gerontology and Geriatrics - Global Aging Research Network (IAGG-GARN) and the IAGG European Region Clinical Section. Recommendations on Physical Activity and Exercise for Older Adults Living in Long-Term Care Facilities: A Taskforce Report. J Am Med Dir Assoc. 2016 May 1;17(5):381-92. doi: 10.1016/j.jamda.2016.01.021. Epub 2016 Mar 21.

    PubMed 27012368
  • Moyle W, Jones C, Murfield J, Draper B, Beattie E, Shum D, Thalib L, O'Dwyer S, Mervin CM. Levels of physical activity and sleep patterns among older people with dementia living in long-term care facilities: A 24-h snapshot. Maturitas. 2017 Aug;102:62-68. doi: 10.1016/j.maturitas.2017.05.015. Epub 2017 May 30.

    PubMed 28610686
  • Dove E, Astell AJ. The Use of Motion-Based Technology for People Living With Dementia or Mild Cognitive Impairment: A Literature Review. J Med Internet Res. 2017 Jan 11;19(1):e3. doi: 10.2196/jmir.6518.

    PubMed 28077346
  • D'Cunha NM, Isbel ST, Frost J, Fearon A, McKune AJ, Naumovski N, Kellett J. Effects of a virtual group cycling experience on people living with dementia: A mixed method pilot study. Dementia (London). 2021 Jul;20(5):1518-1535. doi: 10.1177/1471301220951328. Epub 2020 Aug 21.

    PubMed 32820955
  • Marinus N, Hansen D, Feys P, Meesen R, Timmermans A, Spildooren J. Cycling: how can we activate care-dependent older adults with a mild cognitive impairment? Disabil Rehabil Assist Technol. 2023 Aug;18(6):896-903. doi: 10.1080/17483107.2021.1936665. Epub 2021 Jun 8.

    PubMed 34102092
  • Zorz S, Dellaire S, Reilly K, Wilson-Sanchez J, Rodriguez RA, Campbell TM. Reminiscence-tied cycling technology in long-term care: A feasibility study. J Am Geriatr Soc. 2021 Oct;69(10):2987-2990. doi: 10.1111/jgs.17307. Epub 2021 Jun 5. No abstract available.

    PubMed 34089262
  • Weiner MF, Martin-Cook K, Svetlik DA, Saine K, Foster B, Fontaine CS. The quality of life in late-stage dementia (QUALID) scale. J Am Med Dir Assoc. 2000 May-Jun;1(3):114-6.

    PubMed 12818023
  • Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

    PubMed 11491192
  • Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

    PubMed 9153155
  • Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

    PubMed 1991946
  • Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.

    PubMed 10380242
  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

Questions about this trial

What is this clinical trial studying?

A study testing Motion based - Virtual cycling in people with Dementia and Cognitive Impairment, run by Marie Matérne at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie Matérne, PhD (+46707961388, marie.materne@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life- Quality of Life in Late-Stage Dementia (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06466460, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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