Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000037303
Ethics application status
Approved
Date submitted
22/01/2008
Date registered
23/01/2008
Date last updated
5/12/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of exercise rehabilitation on mobility in home-dwelling patients with dementia - a randomized, controlled, intervention study
Scientific title
Dementia patients and their caregivers-exercise rehabilitation vs. usual care - mobility assessed with Guralnik tests
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 2737 0
Condition category
Condition code
Physical Medicine / Rehabilitation 2863 2863 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients allocated to intervention are randomized to receive geriatric physiotherapy and rehabilitation either individually by a physiotherapist at home (one hour twice a week for 12 months, to increase and improve muscular strength and control, mobility, gait control and balance), or as group therapy sessions in a day care center by phsyiotherapists (4 hour sessions twice a week for 12 months, to increase and improve muscular strength and control, mobility, gait control and balance)
Intervention code [1] 2490 0
Rehabilitation
Comparator / control treatment
Usual care involves all care and procedures which are available for dementia patients within the Finnish health care system
Control group
Active

Outcomes
Primary outcome [1] 3747 0
Mobility according to Guralnik tests
Timepoint [1] 3747 0
12 months
Secondary outcome [1] 6329 0
Physical function (Barthel index), institutionalization, behavioral symptoms, falls, caregiver burden, cost-effectiveness, total mortality
Timepoint [1] 6329 0
12 months

Eligibility
Key inclusion criteria
Diagnosis of Alzheimer's disease, home-dwelling with spouse,65 years or older,frail
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
terminal disease, hemiparesis, immobile

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 740 0
Finland
State/province [1] 740 0

Funding & Sponsors
Funding source category [1] 3003 0
Government body
Name [1] 3003 0
KELA
Country [1] 3003 0
Finland
Primary sponsor type
Government body
Name
KELA
Address
Nordenskioldinkatu 12 00250 Helsinki
Country
Finland
Secondary sponsor category [1] 2702 0
Charities/Societies/Foundations
Name [1] 2702 0
Vanhustyon keskusliitto
Address [1] 2702 0
Malmin kauppatie 26 00700 Helsinki
Country [1] 2702 0
Finland

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 28313 0
Address 28313 0
Country 28313 0
Phone 28313 0
Fax 28313 0
Email 28313 0
Contact person for public queries
Name 11470 0
Timo Strandberg
Address 11470 0
Aapistie 1, 90014 Oulun yliopisto
Country 11470 0
Finland
Phone 11470 0
+358405969285
Fax 11470 0
Email 11470 0
[email protected]
Contact person for scientific queries
Name 2398 0
Timo Strandberg
Address 2398 0
Aapistie 1 90014 Oulun yliopisto
Country 2398 0
Finland
Phone 2398 0
+358405969285
Fax 2398 0
Email 2398 0
timo,[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSeverity of frailty and the outcome of exercise intervention among participants with Alzheimer disease: A sub-group analysis of a randomized controlled trial.2016https://dx.doi.org/10.1016/j.eurger.2015.12.014
EmbaseEffect of exercise on drug-related falls among personswith alzheimer's disease: A secondary analysis of the finalex study.2018https://dx.doi.org/10.1007/s40266-018-0594-7
EmbaseRelationship of Neuropsychiatric Symptoms with Falls in Alzheimer's Disease - Does Exercise Modify the Risk?.2018https://dx.doi.org/10.1111/jgs.15614
Dimensions AIExercise rehabilitation on home-dwelling patients with Alzheimer's disease - a randomized, controlled trial. Study protocol2010https://doi.org/10.1186/1745-6215-11-92
N.B. These documents automatically identified may not have been verified by the study sponsor.