NCT06466460

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 Few nursing homes have used this method, but a pilot project (unpublished) at nursing home for people with dementia, the investigators observed positive effects on the residents' quality of life.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. 1.Does virtual cycling contribute to an improved quality of life for older people with cognitive impairment?
  2. 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. 3.What experiences do residential staff and research assistants have regarding the opportunities and obstacles for implementing virtual cycling?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
44mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Sep 2024Dec 2029

First Submitted

Initial submission to the registry

June 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 20, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.3 years

First QC Date

June 7, 2024

Last Update Submit

January 8, 2026

Conditions

Keywords

interactive technologyquality of lifemotion basedintervention

Outcome Measures

Primary Outcomes (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.

    10 weeks

Secondary Outcomes (5)

  • Quality of life- EuroQol-5 Dimensions-5 Levels

    10 weeks

  • Behavioral and psychological symptoms- The Neuropsychiatric Inventory

    10 weeks

  • Physical test- The Timed Chair Stand Test

    10 weeks

  • Physical test- The Timed Up and Go

    10 weeks

  • Cognitive test- The Mini-Mental State Examination

    10 weeks

Other Outcomes (3)

  • Use of medication

    12 weeks

  • Health data- Body Mass Index

    10 weeks

  • Number of falls

    24 weeks

Study Arms (2)

Motion based intervention

EXPERIMENTAL

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

No intervention

NO INTERVENTION

no intervention for this group

Interventions

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

Motion based intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of behavioural, social and legal sciences

Örebro, 70182, Sweden

RECRUITING

Related Publications (12)

  • 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.

    PMID: 27012368BACKGROUND
  • 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.

    PMID: 28610686BACKGROUND
  • 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.

    PMID: 28077346BACKGROUND
  • 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.

    PMID: 32820955BACKGROUND
  • 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.

    PMID: 34102092BACKGROUND
  • 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.

    PMID: 34089262BACKGROUND
  • 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.

    PMID: 12818023BACKGROUND
  • 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.

    PMID: 11491192BACKGROUND
  • 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.

    PMID: 9153155BACKGROUND
  • 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.

    PMID: 1991946BACKGROUND
  • 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.

    PMID: 10380242BACKGROUND
  • 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.

    PMID: 1202204BACKGROUND

MeSH Terms

Conditions

DementiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Marie Matérne

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Matérne, PhD

CONTACT

Alexandra Björck, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 20, 2024

Study Start

September 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

We could share on other researchers request.

Locations