Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001290280p
Ethics application status
Not yet submitted
Date submitted
7/07/2018
Date registered
31/07/2018
Date last updated
31/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Spinning to help manage your Parkinson's Disease
Scientific title
High Cadence, low resistance spinning increasing functioning and quality of life in Parkinsons Disease in Christchurch, New Zealand; a pilot study.
Secondary ID [1] 295459 0
Nil known
Universal Trial Number (UTN)
U1111-1216-9122
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
parkinsons 308713 0
Condition category
Condition code
Neurological 307653 307653 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 307730 307730 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment Appointment:
- 30 min appointment with medical doctor at Forte Sports
- Assessment of pre exercise questionnaire and clearance to exercise
- AHA/ACSM Health/ Fitness Facility Pre-participation Screening Questionnaire
- Baseline testing including:
- Timed Up and Go Test : measure of mobility and bradykinesia during walking.
This involves standing up from a chair and walking a distance of 3m then turning
around and walking back to the chair and sitting down. Average of 3 trials will be
recorded.
- Blood Pressure
- Calculation of HR reserve (Max HR - resting HR)
- Unified Parkinson’s Disease Rating Scale
Exercise Intervention:
12 week program
3 sessions per week
Monday, Wednesday, Friday 0930 am.
First Session: (allow an extra ten minutes).
- Orientation to gym facility
- Bike set up
Each Session:
- 5 min warm up (self paced but 40-50 rpm)
- 30 mins of cycling at 75-85 rpm low resistance, HR of 50-80% HR reserve
- 5 mins cool down ( self paced but 40-50 rpm).
- Virtual instructor to follow on the screen or a screen based ride in the countryside.
Supervision:
- Attendance marked off at start of session
- Medical Doctor present for all sessions
- Instructor (trained fitness professional) present for all sessions
3 sessions:
- During the first, half way through and last session the doctor will record your cadence
and heart rate at 10min intervals during the session.
Assessment at 6 weeks:
- Timed Up and Go Test
- Blood Pressure
- Unified Parkinson’s Disease Rating Scale
Assessment at 12 weeks:
- Timed Up and Go Test- Blood Pressure
- Unified Parkinson’s Disease Rating Scale
Session attendance checklist for each session will be marked off.
Intervention code [1] 301770 0
Lifestyle
Intervention code [2] 301836 0
Rehabilitation
Intervention code [3] 301837 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306641 0
TImed up and Go Test
Timepoint [1] 306641 0
Baseline, 6 weeks and 12 weeks post commencement of intervention.
Primary outcome [2] 306642 0
Unified Parkinson’s Disease Rating Scale
Timepoint [2] 306642 0
Baseline, 6 weeks and 12 weeks post commencement of intervention
Secondary outcome [1] 349344 0
Blood Pressure - manually assessed using sphygmomanometer.
Timepoint [1] 349344 0
Baseline, 6 weeks and 12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Diagnosis of Parkinsons Disease

Assessed as safe to exercise
Minimum age
50 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Surgery for Parkinsons Disease
Recent AMI in last 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study to show ability to apply previous research to our population.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2018
Actual
Date of last participant enrolment
Anticipated
31/10/2018
Actual
Date of last data collection
Anticipated
30/01/2019
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 10625 0
New Zealand
State/province [1] 10625 0
Canterbury

Funding & Sponsors
Funding source category [1] 300050 0
Self funded/Unfunded
Name [1] 300050 0
Eloise Matthews
Country [1] 300050 0
New Zealand
Primary sponsor type
Individual
Name
Eloise Matthews
Address
Forte sports
Level 1
Forte 2
132 Peterborough St
Christchurch
8014
Country
New Zealand
Secondary sponsor category [1] 299444 0
None
Name [1] 299444 0
Address [1] 299444 0
Country [1] 299444 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300896 0
Health and Disability Ethics Committee
Ethics committee address [1] 300896 0

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 300896 0
New Zealand
Date submitted for ethics approval [1] 300896 0
20/08/2018
Approval date [1] 300896 0
Ethics approval number [1] 300896 0

Summary
Brief summary
We aim to get members of the parkinsons community enjoying an exercise program on spin bikes. Studies in America have shown increased quality of life and reduced parkinsons symptoms with high cadence cycling and we aim to bring these benefits to the Christchurch community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85198 0
Dr Eloise Matthews
Address 85198 0
Forte Sports
Level 1,
132 Peterborough Street
Christchurch
8014
Country 85198 0
New Zealand
Phone 85198 0
+6421464974
Fax 85198 0
Email 85198 0
eloise.matthews@fortesports.co.nz
Contact person for public queries
Name 85199 0
Dr Eloise Matthews
Address 85199 0
Forte Sports
Level 1,
132 Peterborough Street
Christchurch
8014
Country 85199 0
New Zealand
Phone 85199 0
+64 3 384 2690
Fax 85199 0
Email 85199 0
eloise.matthews@fortesports.co.nz
Contact person for scientific queries
Name 85200 0
Dr Eloise Matthews
Address 85200 0
Forte Sports
Level 1,
132 Peterborough Street
Christchurch
8014
Country 85200 0
New Zealand
Phone 85200 0
+64 3 384 2690
Fax 85200 0
Email 85200 0
eloise.matthews@fortesports.co.nz

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
No additional documents have been identified.