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Trial registered on ANZCTR


Registration number
ACTRN12612000658819
Ethics application status
Approved
Date submitted
19/06/2012
Date registered
19/06/2012
Date last updated
19/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of foot massage on agitation in people with dementia living in residential care.
Scientific title
The effect of foot massage on agitation in people with dementia living in residential care: a randomized control trial.
Secondary ID [1] 280616 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Agitated behaviours in people with dementia 286629 0
Condition category
Condition code
Mental Health 286910 286910 0 0
Other mental health disorders
Neurological 286974 286974 0 0
Dementias
Alternative and Complementary Medicine 286975 286975 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foot massage involving long gliding, rhythmical strokes of the entire foot and ankle, and light pressure massage by a certified therapist in the privacy of the participant's bedroom. The intervention consists of 5 minutes massage for each foot, 5 times a week (Mon-Fri) from 1pm-4pm (at a standardized time for each individual) for a period of 3 weeks. After completion of the first treatment arm of the study and after a wash out period of three weeks, participants will then be exposed to the opposite treatment arm and the protocol repeated, that is, those in the first foot massage condition will then move to the quiet presence condition and vice versa.
Intervention code [1] 285015 0
Behaviour
Intervention code [2] 285058 0
Treatment: Other
Comparator / control treatment
Participants in the control arm (quiet presence) will not receive foot massage but will instead have an research assistant sit with them in quiet presence, i.e., close to the resident but not in direct skin to skin contact and no deliberate communication. This activity will also be conducted in participating residents’ bedrooms for 10-minutes, five times a week (Mon-Fri), from 1pm-4pm (at a standardized time for each individual), for a period of three weeks.
Control group
Active

Outcomes
Primary outcome [1] 287266 0
Measure of Agitation using Pittsburgh Agitation Scale (PAS) and Cohen-Mansfield Agitation Inventory (CMAI).
Timepoint [1] 287266 0
a) Pre-massage/quiet presence intervention period (baseline)
b) Post-massage/quiet presence intervention period (before cross over/wash-out)
c) Post-cross over treatment
Secondary outcome [1] 297795 0
Measure of Depression using the Geriatric Depression Scale (GDS)
Timepoint [1] 297795 0
a) Pre-massage/quiet presence intervention period (baseline)
b) Post-massage/quiet presence intervention period (before cross over/wash-out)
c) Post-cross over treatment
Secondary outcome [2] 297796 0
Measure of Emotion and Discomfort using Observed Emotion Rating Scale (OERS) and Discomfort Scale for Dementia of the Alzheimer's Type (DSD).
Timepoint [2] 297796 0
a) Pre-massage/quiet presence intervention period (baseline)
b) Post-massage/quiet presence intervention period (before cross over/wash-out)
c) Post-cross over treatment
Secondary outcome [3] 297797 0
Measure of physiologic stress by monitoring blood pressure and heart rate using an Omron HEM-7070 electronic sphygmomanometer and body temperature using a No Touch Temporal Artery Thermometer.
Timepoint [3] 297797 0
Pre- and post- each massage intervention and quiet presence

Eligibility
Key inclusion criteria
1) informed consent (i.e., authority received from resident’s themselves and/or relatives and health attorneys to join the research)
2) permanent residence in one of the four chosen residential care facilities in the Brisbane area of South East Queensland for at least 2 months
3) two feet, excluding artificial legs
4) no specific medical-related contraindications (e.g., recent surgery to the area, vessel embolism, peripheral neuropathy, painful bunions or acute illness)
5) a diagnosis of dementia, or met the criteria for probable dementia of Alzheimer’s type as per DSM-IV
6) a Mini Mental State Exam (MMSE) score of < 18 indicating moderate to severe dementia
7) a documented history of agitation on nursing or medical records within the previous two weeks
8) a score of >3 points on the PAS 30 during each day over a period of one week. (the screening component of the PAS is used here and the full observation is used in the data collection)
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) consent unobtainable
2) those that are not residents of the care facilities chosen for this trial
3) not having two feet
4) those that have specific medical-related contraindications (e.g., recent surgery to the area, vessel embolism, peripheral neuropathy, painful bunions or acute illness)
5) no diagnosis of dementia, or not met the criteria for probable dementia of Alzheimer’s type as per DSM-IV
6) a Mini Mental State Exam (MMSE) score of > 18
7) a score of <3 points on the PAS 30 during each day over a period of one week.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Under the guidance of a biostatistician, an RA not associated with data collection will conduct the randomization process using a computer-generated program and prepare sequentially numbered sealed opaque envelopes that will outline the different ordering of treatments for each participant. Randomisation will be blocked to ensure that there are equal numbers of participants receiving the intervention and the control activities.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
For staff to remain blind to the participants’ group assignments all participants will have their feet exposed regardless of which the group they are allocated to. Staff will be requested to refrain from attending participants’ rooms during the intervention, a do not disturb sign will be placed on the door and staff will be informed that the intervention requires participants to be given quiet, undisturbed time.

Data collection research assistants will also be blinded to the purpose of the study and the type and timing of the intervention with data collection taking place outside of the time given to the intervention, i.e., before the intervention, end of intervention and post intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285378 0
Government body
Name [1] 285378 0
National Health and Medical Research Council (NHMRC) Dementia Research Grants Program
Address [1] 285378 0
Level 1
16 Marcus Clarke Street
Canberra
ACT 2601
Country [1] 285378 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 284273 0
None
Name [1] 284273 0
Address [1] 284273 0
Country [1] 284273 0
Other collaborator category [1] 276868 0
Other
Name [1] 276868 0
Churches of Christ Residential Aged Care
Address [1] 276868 0
41 Brookfield Road
Kenmore
QLD 4069
Country [1] 276868 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287396 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287396 0
170 Kessels Road,
Nathan
QLD 4111
Ethics committee country [1] 287396 0
Australia
Date submitted for ethics approval [1] 287396 0
Approval date [1] 287396 0
30/04/2009
Ethics approval number [1] 287396 0
NRS/08/08/HREC

Summary
Brief summary
Behavioural changes including agitation occur to a significant degree in up to 90% of people with dementia. This experimental, within-subjects, crossover design study with nursing home residents aims to compare the effects of foot massage and quiet presence on agitated behaviours in people living with moderate to severe dementia in residental care settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34265 0
Address 34265 0
Country 34265 0
Phone 34265 0
Fax 34265 0
Email 34265 0
Contact person for public queries
Name 17512 0
Professor Wendy Moyle
Address 17512 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 17512 0
Australia
Phone 17512 0
+61 (0) 7 3735 5526
Fax 17512 0
Email 17512 0
w.moyle@griffith.edu.au
Contact person for scientific queries
Name 8440 0
Professor Wendy Moyle
Address 8440 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 8440 0
Australia
Phone 8440 0
+61 (0) 7 3735 5526
Fax 8440 0
Email 8440 0
w.moyle@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary