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Trial registered on ANZCTR


Registration number
ACTRN12605000566639
Ethics application status
Approved
Date submitted
30/09/2005
Date registered
30/09/2005
Date last updated
30/09/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Strength training for people with Parkinson's disease
Scientific title
Evaluation of a randomized trial of community-based progressive strength training for people with Parkinson's disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 692 0
Condition category
Condition code
Neurological 767 767 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 10-week program of progressive resistance strength training based upon the recommendations of the American College of Sports Medicine (American College of Sport Medicine ACSM Position Stand 2002). The resistance exercise program is based on the Strong for Life protocol described by Jette et al. (1999). A physiotherapist will assess the participants' ability to complete the exercise program as described and will modify the exercises as appropriate. Participants will attend an exercise group twice per week for 10-weeks. In addition, the participants will be asked to complete a set progressive resistance strengthening program once per week in their own hom
Intervention code [1] 690 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 972 0
Muscle Strength
Maximum force generated during an isometric muscle contraction will be measured using a hand-held dynamometer to assess the strength of the muscle group: plantar flexors.
Timepoint [1] 972 0
Primary outcome [2] 973 0
Muscle Strength
Maximum force generated during an isometric muscle contraction will be measured using a hand-held dynamometer to assess the strength of the following muscle groups: knee extensors.
Timepoint [2] 973 0
Primary outcome [3] 974 0
Muscle Strength
Maximum force generated during an isometric muscle contraction will be measured using a hand-held dynamometer to assess the strength of the following muscle groups: elbow flexors.
Timepoint [3] 974 0
Primary outcome [4] 975 0
Muscle Strength
Maximum force generated during an isometric muscle contraction will be measured using a hand-held dynamometer to assess the strength of the following muscle groups: elbow extensors.
Timepoint [4] 975 0
Primary outcome [5] 976 0
The maximum weight that can be lifted for a single repetition will also be used as a measure of the maximum isokinetic force that can be generated. Maximum force will be measured for a seated chest press and seated leg extension.
Timepoint [5] 976 0
Secondary outcome [1] 1846 0
Footstep patterns
Footstep patterns will be measured using the GAITRite® instrumented walkway system. The following footstep parameters will be measured: walking speed, step length, cadence, step width and double limb support time as a percentage of the gait cycle.
Timepoint [1] 1846 0
Secondary outcome [2] 1847 0
Walking endurance
Walking endurance will be measured using the six-minute walk test (6mwt) (Lipkin, Scriven et al. 1986), which is a sub-maximal test of endurance. The test requires the participant to walk as far as possible during the test period although participants are allowed to sit down to rest as required.
Timepoint [2] 1847 0
Secondary outcome [3] 1848 0
Upper extremity function
The Upper Extremity Functional Index (Stratford, Binkley et al. 2001) is a self-rated questionnaire that requires the participants to rate the level of difficulty in performing 20 upper limb tasks on a 5 point Likert Scale. The questions require the participant to evaluate their performance in tasks such as vacuuming, sweeping, using tools or appliances and lifting a bag of groceries.
Timepoint [3] 1848 0
Secondary outcome [4] 1849 0
Measure of participation
Participation restrictions will be measured using the London Handicap Scale (LHS) (Harwood, Gompertz et al. 1994), which is a self-rated measure of disadvantage associated with chronic disease. The scale assesses six domains related to participation: mobility, physical independence, occupation, social integration, orientation and economic self-sufficiency.
Timepoint [4] 1849 0
Secondary outcome [5] 1850 0
Adverse events
Adverse events that may be related to participation in the progressive resistance strength training program will be recorded by the physiotherapist who is supervising the program. The physiotherapist will ask each participant at the beginning and the end of each group training session if they have noticed any injuries or other problems that may be related to the training program. All reports of injuries or problems will be recorded in detail using an incident report form.
Timepoint [5] 1850 0

Eligibility
Key inclusion criteria
i. Diagnosis of Pari. Diagnosis of Parkinson's disease confirmed using the United Kingdom Brain Bank Parkinson's disease criteria; ii. Medical clearance to participate in a strength training program;iii. Rated between Grade I and Grade IV on the Hoehn & Yahr staging of Parkinson's disease. This will include people whose disease severity is not so severe that it would prevent them from participating in a group exercise training program; and iv. Able to walk without physical assistance for at least 14 meters (this is because one of the aims of this investigation is to improve walking ability and requires the assessment of walking). Kinson's disease confirmed using the United Kingdom Brain Bank Parkinson's disease criteria; ii. Medical clearance to participate in a strength training program; iii. Rated between Grade I and Grade IV on the Hoehn & Yahr staging of Parkinson's disease. This will include people whose disease severity is not so severe that it would prevent them from participating in a group exercise training program; and iv. Able to walk without physical assistance for at least 14 meters (this is because one of the aims of this investigation is to improve walking ability and requires the assessment of walking).
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Rated Grade V -VI on the Hoehn & Yahr staging of Parkinson's disease. This will exclude people who would be unlikely to have the physical capacity to participate in the progressive strength training program due to severe symptoms of PD;ii. Significant cognitive impairment (less than 16 on the Mini Mental Status Examination) and therefore unlikely to be able to follow instructions used in the implementation of the training program; andiii. Unable to travel to the Ballarat Community Health Centre to participate in the exercise program.

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)
Prior to participant recruitment, a set of opaque sealed envelopes numbered 1-15 will be prepared for each stratum (disease severity I -II and III - IV). The envelopes will be prepared by Associate Professor K. Dodd who will not be involved in enrolling participants into the study, assessment or intervention. The research co-ordinator who will not be involved in either enrolling the participants or generating the allocation sequence will assign each participant in each stratum a number that is determined by their order of assessment. The participants name will be written on the envelop that matches their number and then the envelop will be opened to reveal if the participant has been allocated to the intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will then be randomly allocated to the intervention or control group using stratification for disease severity. Stratification will be based upon the Hoehn & Yahr disease severity classification and will be used to assist in the allocation of equal numbers of people with disease severity I or II and III or IV in each group. A block randomization list will be produced for disease severity I -II and III - IV. The allocation sequences will be generated using blocks to minimise the risk of unequal group sizes. For each block, there are six possible allocation sequences. The allocation sequences will be generated using a random digit table, where an odd number will indicate intervention group and an even number will indicate control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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] 847 0
Charities/Societies/Foundations
Name [1] 847 0
Ballarat Community Health Centre
Address [1] 847 0
Country [1] 847 0
Australia
Funding source category [2] 848 0
Hospital
Name [2] 848 0
Ballarat Health Services
Address [2] 848 0
Country [2] 848 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Ballarat Community Health Centre
Address
Country
Australia
Secondary sponsor category [1] 714 0
Hospital
Name [1] 714 0
Ballarat Health Services
Address [1] 714 0
Country [1] 714 0
Australia
Secondary sponsor category [2] 715 0
University
Name [2] 715 0
University of Ballarat
Address [2] 715 0
Country [2] 715 0
Australia
Secondary sponsor category [3] 716 0
University
Name [3] 716 0
La Trobe University
Address [3] 716 0
Country [3] 716 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2111 0
Ballarat Health Services
Ethics committee address [1] 2111 0
Ethics committee country [1] 2111 0
Australia
Date submitted for ethics approval [1] 2111 0
Approval date [1] 2111 0
Ethics approval number [1] 2111 0
Ethics committee name [2] 2112 0
University of Ballarat
Ethics committee address [2] 2112 0
Ethics committee country [2] 2112 0
Australia
Date submitted for ethics approval [2] 2112 0
Approval date [2] 2112 0
Ethics approval number [2] 2112 0
Ethics committee name [3] 2113 0
La Trobe University
Ethics committee address [3] 2113 0
Ethics committee country [3] 2113 0
Australia
Date submitted for ethics approval [3] 2113 0
Approval date [3] 2113 0
Ethics approval number [3] 2113 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36010 0
Address 36010 0
Country 36010 0
Phone 36010 0
Fax 36010 0
Email 36010 0
Contact person for public queries
Name 9879 0
Dr Belinda Bilney
Address 9879 0
Ballarat Health Services
Queen Elizabeth Centre
102 Ascot St
Ballarat VIC 3350
Country 9879 0
Australia
Phone 9879 0
+61 3 53203994
Fax 9879 0
Email 9879 0
belindab@bhs.org.au
Contact person for scientific queries
Name 807 0
Dr Belinda Bilney
Address 807 0
Ballarat Health Services
Queen Elizabeth Centre
102 Ascot St
Ballarat VIC 3350
Country 807 0
Australia
Phone 807 0
+61 3 53203994
Fax 807 0
Email 807 0
belindab@bhs.org.au

No information has been provided regarding IPD availability
Summary results
No Results