Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000303347
Ethics application status
Approved
Date submitted
13/06/2008
Date registered
20/06/2008
Date last updated
23/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise to prevent falls in people with Parkinson's disease
Scientific title
Exercise therapy for prevention of falls in people with Parkinson's disease: a randomised controlled trial
Secondary ID [1] 578 0
Nil
Universal Trial Number (UTN)
Trial acronym
PD_FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 3252 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3415 3415 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will undertake a 40-60 min program of home-based balance and leg strength exercises three times a week for six months. Evidence-based cueing strategies will be used to assist patients to manage freezing. In addition, participants can choose to participate in a once a month exercise class (for six months) conducted by a physiotherapist in association with their local Parkinson’s NSW/ACT Support Group or hospital.

Participants will be provided with a booklet containing safety precautions, instructions and photographs of exercises for use in exercise sessions at home, as well as information sheets detailing strategies for managing freezing. In addition, they will be provided with a logbook for recording exercises completed and any adverse effects of exercise (eg, muscle soreness).

Participants will also receive standardised falls prevention advice and will be provided with a falls diary for recording falls.
Intervention code [1] 2827 0
Rehabilitation
Comparator / control treatment
The control group will have standardised falls prevention advice and will be provided with a falls diary for recording falls.
Control group
Active

Outcomes
Primary outcome [1] 4125 0
Falls: Falls will be assessed by comparing the number and rate of falls in intervention and control groups. The proportion of fallers in each group will also be compared.
Timepoint [1] 4125 0
Falls diary will be returned to the researchers monthly for 6 months using pre-paid envelopes and will be followed up by a phone call to verify the falls details.
Secondary outcome [1] 6948 0
Parkinson's Disease Falls Risk Score: Falls risk status will be determined using the Parkinson's disease-specific algorithm validated in a recent large prospective cohort study (Latt 2006)
Timepoint [1] 6948 0
At baseline and at the end of the six months intervention period
Secondary outcome [2] 6949 0
Knee extension (quadriceps) muscle strength: Strength of each leg will be measured using a spring gauge.
Timepoint [2] 6949 0
At baseline and at the end of the six months intervention period.
Secondary outcome [3] 6950 0
Balance in standing: measured using the coordinated stability tests and maximal balance range in standing tests. The step test compoenent from the Berg Balance Scale will be performed and timed.
Timepoint [3] 6950 0
At baseline and at the end of the six months intervention period
Secondary outcome [4] 6951 0
Short Physical Performance Battery (SPPB): including tests of walking, balanced standing and sit to stand.
Timepoint [4] 6951 0
At baseline and at the end of the six months intervention period
Secondary outcome [5] 6952 0
Freezing of Gait: measured using the Freezing of Gait Questionnaire (FOGQ)
Timepoint [5] 6952 0
At baseline and at the end of the six months intervention period
Secondary outcome [6] 6953 0
Fear of falls: measured using the Falls Efficacy Scale International (FES-I)questionnaire
Timepoint [6] 6953 0
At baseline and at the end of the six months intervention period
Secondary outcome [7] 6954 0
Quality of life: measured using Parkinson's Disease Questionnaire-39 (PDQ-39), a Parkinson's disease specific quality of life questionnaire
Timepoint [7] 6954 0
At baseline and at the end of the six months intervention period
Secondary outcome [8] 6955 0
Habitual physical activity levels: measured using a habitual physical activity levels questionnaire
Timepoint [8] 6955 0
At baseline and at the end of the six months intervention period
Secondary outcome [9] 6956 0
Health and Well-being: measured using the SF-12v2(TM) Health Survey
Timepoint [9] 6956 0
At baseline and at the end of the six months intervention period
Secondary outcome [10] 6957 0
Positive and Negative Affect: measured using the Positive and Negative Affect Schedule (PANAS)
Timepoint [10] 6957 0
At baseline and at the end of the six months intervention period
Secondary outcome [11] 7288 0
Total cost: including the cost of the program and the cost of subsequent health care services utilization
Timepoint [11] 7288 0
Data will be collected monthly for six months

Eligibility
Key inclusion criteria
(1) Have a diagnosis of idiopathic Parkinson’s disease

(2) Have adapted to their current anti-Parkinsonian medication for at least 2 weeks

(3) Are aged 40 years or over

(4) Are able to walk independently (with or without a walking aid)

(5) Have a history of falls (at least one fall in the previous 12 months) or are at risk of falls
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Have a Mini-Mental State Examination score of < 24

(2) Suffer from unstable cardiovascular disease or other uncontrolled chronic conditions that would interfere with the safety and conduct of the training and testing protocol or interpretation of the results

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After the baseline assessment, participants will be stratifed according to falls history (0-10 falls in past 12 months/>10 falls in past 12 months) then allocated randomly to the intervention group or the control group. Randomisation will be performed centrally by a staff member not involved in recruitment or assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be ahieved using computer generated random numbers and randomly permuted blocks.
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
11/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3338 0
Government body
Name [1] 3338 0
National Health and Medical Research Counicl
Country [1] 3338 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Clinical and Rehabilitation Sciences Research Group, The University of Sydney, PO Box 170, Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 2983 0
None
Name [1] 2983 0
Address [1] 2983 0
Country [1] 2983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5362 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 5362 0
Room 313A, Old Teachers College A22
The University of Sydney
NSW 2006
Ethics committee country [1] 5362 0
Australia
Date submitted for ethics approval [1] 5362 0
Approval date [1] 5362 0
30/11/2007
Ethics approval number [1] 5362 0
11-2007/10487

Summary
Brief summary
100,000 Australians have Parkinson’s disease (PD) at any one time and up to 68% of these people will fall each year. Reduced balance, reduced leg muscle strength and freezing of gait have been identified as risk factors for falls in people with PD. This project will test the efficacy and cost-effectiveness of an exercise program in reducing falls in people with PD. Participants will be randomly allocated to an exercise group or a control group. Both groups will receive standardized falls prevention advice and will keep a falls diary. The exercise group will also participate in a home-based balance and leg strengthening exercise program for 6 months, with the option of attending a once a month support-group based exercise class. Evidence-based cueing strategies will be used to assist participants to manage freezing. The study has been designed using the criteria developed by the Cochrane database and the Physiotherapy Evidence Database (PEDro) for best practice in the conduct of randomized controlled trials. The effect of the program on frequency of falls, lower limb strength, balance, fear of falling and quality of life will be investigated as well as the cost-effectiveness of the program. Any reduction in the frequency of falls for people with PD will reduce the personal and financial costs to individuals with PD, their families, health care resources and the community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28551 0
Address 28551 0
Country 28551 0
Phone 28551 0
Fax 28551 0
Email 28551 0
Contact person for public queries
Name 11708 0
Dr Colleen Canning
Address 11708 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO BOX 170
LIDCOMBE NSW 1825
Country 11708 0
Australia
Phone 11708 0
+61 2 9351 9263
Fax 11708 0
+61 2 9351 9278
Email 11708 0
[email protected]
Contact person for scientific queries
Name 2636 0
Dr Colleen Canning
Address 2636 0
Discipline of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO BOX 170
LIDCOMBE NSW 1825
Country 2636 0
Australia
Phone 2636 0
+61 2 9351 9263
Fax 2636 0
+61 2 9351 9278
Email 2636 0
[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
EmbaseExercise for falls prevention in Parkinson disease: A randomized controlled trial.2015https://dx.doi.org/10.1212/WNL.0000000000001155
EmbaseEconomic evaluation of a falls prevention exercise program among people With Parkinson's disease.2016https://dx.doi.org/10.1002/mds.26420
N.B. These documents automatically identified may not have been verified by the study sponsor.