NCT03001232

Brief Summary

The purpose of this study is to determine whether movement-oriented dementia care has a positive effect on quality of life and independence in activities of daily living (ADL) in nursing-home residents with dementia. It was hypothesized that movement-oriented dementia care has a positive effect on quality of life and independence in ADL, as well as on mood, behavior, cognition and physical functioning, in comparison to regular care.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2016

Completed
Last Updated

February 3, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

December 20, 2016

Last Update Submit

February 2, 2017

Conditions

Keywords

Movement-oriented Dementia CareQoLADLNursing Home

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Activities of Daily Living (ADL), measured with the Barthel Index.

    The Barthel Index is a survey consisting of 10 performance items (e.g. toilet use, dressing) rated on an ordinal scale (two-point, three-point or four-point scale), indicating the level of help needed. Scores range from 0 to 20, with higher scores representing a higher level of functional independence.

    baseline and 3, 6, 9 and 12 months after baseline assessment

  • Change from Baseline in Quality of Life (QoL), measured with the Qualidem

    The Qualidem is a questionnaire with 40 items of observable behaviour rated on a four-point rating scale, ranging from 1 (never) to 4 (often). There is no total score; scores can only be obtained for the nine subscales. For each subscale, a higher score represented a better quality of life.

    baseline and 3, 6, 9 and 12 months after baseline assessment

Secondary Outcomes (7)

  • Change from Baseline in general cognitive functions, measured with the Severe Impairment Battery 8 (SIB-8).

    baseline and 3, 6, 9 and 12 months after baseline assessment.

  • Change from Baseline in mood, measured with the Cornell Scale for Depression in Dementia (CSDD).

    baseline and 3, 6, 9 and 12 months after baseline assessment

  • Change from Baseline in behaviour, measured with the Apathy Evaluation Scale-10 (AES-10).

    baseline and 3, 6, 9 and 12 months after baseline assessment.

  • Change from Baseline in behaviour, measured with the Cohen-Mansfield Agitation Inventory (CMAI).

    baseline and 3, 6, 9 and 12 months after baseline assessment.

  • Change from Baseline in aerobic fitness, measured with the two minute walking test (2mWT).

    baseline and 3, 6, 9 and 12 months after baseline assessment

  • +2 more secondary outcomes

Other Outcomes (1)

  • Degree of implementation of MDC at each ward measured with process evaluations.

    3, 6, 9 and 12 months of intervention.

Study Arms (2)

Movement-oriented Dementia Care

EXPERIMENTAL

The experimental group received movement-oriented dementia care for a period of twelve months.Movement-oriented dementia care is a multidisciplinary approach in which all involved disciplines focus on stimulating physical activity and independence as much as possible. This way physical activity is stimulated at all times for the participants.

Behavioral: Movement-oriented Dementia Care

Care as usual

NO INTERVENTION

The control group received care as usual

Interventions

The intervention is a new multidisciplinary approach that focuses on optimizing physical activity and independence in daily care and activities. MDC intended to incorporate all persons surrounding the patients. The nursing staff was intensively trained by an expert in MDC, and played a central role in continuously stimulating patients to function as independently as possible. Geriatric physicians and physiotherapists advised the nursing staff about participants' medical and physical limitations to ensure safe stimulation. Consequently, a plan was created for each resident to determine the daily routines they were capable of performing themselves. Caregivers and volunteers were informed about the benefits of an active lifestyle during several open meetings.

Movement-oriented Dementia Care

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of dementia (based on medical charts)
  • Living in a psychogeriatric ward of Solis for at least three weeks
  • years of age or older

You may not qualify if:

  • Very bad vision
  • Psychotic symptoms
  • A palliative care protocol
  • A score on the Mini-Mental State Examination (MMSE) of 25 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Ballard C, O'Brien J, James I, Mynt P, Lana M, Potkins D, Reichelt K, Lee L, Swann A, Fossey J. Quality of life for people with dementia living in residential and nursing home care: the impact of performance on activities of daily living, behavioral and psychological symptoms, language skills, and psychotropic drugs. Int Psychogeriatr. 2001 Mar;13(1):93-106. doi: 10.1017/s1041610201007499.

    PMID: 11352339BACKGROUND
  • Blankevoort CG, van Heuvelen MJ, Boersma F, Luning H, de Jong J, Scherder EJ. Review of effects of physical activity on strength, balance, mobility and ADL performance in elderly subjects with dementia. Dement Geriatr Cogn Disord. 2010;30(5):392-402. doi: 10.1159/000321357. Epub 2010 Oct 28.

    PMID: 20980758BACKGROUND
  • Edwards N, Gardiner M, Ritchie DM, Baldwin K, Sands L. Effect of exercise on negative affect in residents in special care units with moderate to severe dementia. Alzheimer Dis Assoc Disord. 2008 Oct-Dec;22(4):362-8. doi: 10.1097/WAD.0b013e31818ecbbc.

    PMID: 18978600BACKGROUND
  • Burge E, Kuhne N, Berchtold A, Maupetit C, von Gunten A. Impact of physical activity on activity of daily living in moderate to severe dementia: a critical review. Eur Rev Aging Phys Act. 2012 Apr;9(1):27-39. doi: 10.1007/s11556-011-0092-y. Epub 2011 Dec 15.

    PMID: 22639696BACKGROUND
  • Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.

    PMID: 20101011BACKGROUND
  • Kemoun G, Thibaud M, Roumagne N, Carette P, Albinet C, Toussaint L, Paccalin M, Dugue B. Effects of a physical training programme on cognitive function and walking efficiency in elderly persons with dementia. Dement Geriatr Cogn Disord. 2010;29(2):109-14. doi: 10.1159/000272435. Epub 2010 Feb 11.

    PMID: 20150731BACKGROUND
  • Morris JN, Fiatarone M, Kiely DK, Belleville-Taylor P, Murphy K, Littlehale S, Ooi WL, O'Neill E, Doyle N. Nursing rehabilitation and exercise strategies in the nursing home. J Gerontol A Biol Sci Med Sci. 1999 Oct;54(10):M494-500. doi: 10.1093/gerona/54.10.m494.

    PMID: 10568531BACKGROUND
  • Wetzels RB, Zuidema SU, de Jonghe JF, Verhey FR, Koopmans RT. Determinants of quality of life in nursing home residents with dementia. Dement Geriatr Cogn Disord. 2010;29(3):189-97. doi: 10.1159/000280437. Epub 2010 Mar 6.

    PMID: 20215750BACKGROUND
  • Galik E, Resnick B, Hammersla M, Brightwater J. Optimizing function and physical activity among nursing home residents with dementia: testing the impact of function-focused care. Gerontologist. 2014 Dec;54(6):930-43. doi: 10.1093/geront/gnt108. Epub 2013 Oct 3.

    PMID: 24092822BACKGROUND
  • Henskens M, Nauta IM, Scherder EJA, Oosterveld FGJ, Vrijkotte S. Implementation and effects of Movement-oriented Restorative Care in a nursing home - a quasi-experimental study. BMC Geriatr. 2017 Oct 23;17(1):243. doi: 10.1186/s12877-017-0642-x.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Marinda Henskens, Msc

    VU University of Amsterdam

    PRINCIPAL INVESTIGATOR
  • Erik JA Scherder, Prof. Dr.

    VU University of Amsterdam

    PRINCIPAL INVESTIGATOR
  • Susan Vrijkotte, Msc

    Zorggroep Solis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

December 20, 2016

First Posted

December 22, 2016

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 3, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share