Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000143820p
Ethics application status
Submitted, not yet approved
Date submitted
30/08/2020
Date registered
12/02/2021
Date last updated
12/02/2021
Date data sharing statement initially provided
12/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Instituting Graduated High intensity exercise Training for Parkinson Disease-FIGHT-PD
Scientific title
Feasibility of Instituting Graduated High intensity exercise Training for Parkinson Disease
Study one in a series of studies aimed at evaluating non- contact boxing exercise as an intervention for Parkinson disease
Secondary ID [1] 302180 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FIGHT-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 318847 0
Condition category
Condition code
Neurological 316851 316851 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention and duration: A supervised exercise program of non-contact boxing utilizing a boxing machine, with instruction by a professional boxing coach and neurological physiotherapist, and oversight by exercise physiologists and a neurologist. The program includes a detailed warm up to sequentially prepare the upper body, trunk, then legs with movements, stretching and balance exercises, and then a series of aerobic exercises.


The first warm up exercise is; "Raised elbows and arm extension, to the side and the front"; the subject stands and the arms are held in a T position with the feet parallel, the legs shoulder width apart; one arm remains extended, then the other is brought close to the head, with each side alternating. The arms are then positioned straight to the front, and alternately flexed and extended. This warms up shoulders, wrists and elbows, Key point is to fully extend the elbow, "locking it out"; this is to counter the rigid, flexed posture typically seen in PD.

A mid-body warm up exercise is "Finger Lock Hook Twists". The starting position is with feet parallel, legs just further than shoulder width apart, the fingers are locked together in a "monkey grip" with the elbows kept high. The body is twisted from side to side, rotating as far as possible. The aim of this is to enhance flexibility and trunk control.
Aerobic exercises include jogging on the spot star jumps and twist jumps.


This is followed by rounds of boxing using standardised sequences of punches and body movements utilising the machine. The attached document summarises the sequences, with the numbers representing the target numbers on the Fightmaster machine corresponding to the style of punch. The program will be administered in a groups of 4 in a large room at the Perron Institute which is also used as a Movement analysis laboratory, but will be functioning as a "gymnasium" for the purposes of this study.The 15 week program will include three, five weeks blocks. The first block will focus on development of boxing technique, with low intensity, approximately 8-10/20 on the Borg RPE scale. Exercise physiology students will quiz participants on their Borg RPE at regular intervals during each workout in order to measure in detail the demands of each component. A modified scale of cognitive demand (1-10) will also be used.The second block will escalate the intensity starting at approximately Borg RPE 12-13, ultimately building towards 18-19, as form and conditioning allow. The third block will consolidate the intensity level, adding in additional cognitive challenges to the physical workout. The cognitive challenges include; 1. Switching from "orthodox" right handed stance, to "Southpaw" (ie left handed), which requires the boxing sequence targets to be the mirror image. 2.Interruption of bimanual sequences by inserting sequences requiring several consecutive left or right punches; this is a surprisingly difficult "inhibitory" task. 3. Learning random sequences " on the fly", typically comprising of 4-7 different punches. Three workouts per week will be performed, ranging from 45-60 minutes duration. Each five week block will include a week with non-workout sessions allocated for assessments and review. Subjects will wear portable heart rate (Polar) monitors that will quantify heart rate during each workout. Subjects will rate their perceived level of physical and mental exertion using the Borg scale at multiple points during the workout. Subjects will complete a questionnaire in a logbook at the end of each workout, assessing the tolerability of each workout and documenting the development of any musculoskeletal pain or change in PD symptoms. The logbooks will provide a record of attendance. The Borg RPE will provide a standardised method of measuring the exertion, and will be correlated with heart rate recordings.
Intervention code [1] 318482 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324962 0
To measure the recruitment and retention of subjects and describe the logistical issues and details of the program.
All interested participant's details will be logged in a study database, together with reasons for exclusion. The number of participants fully completing the program will provide a measure of feasibility.
Timepoint [1] 324962 0
Adherence and retention to be measured at end of 15 week program.
Primary outcome [2] 325263 0
To determine the tolerability of the program. The rate of perceived exertion (RPE) using the Borg scale (6-20) and rate of perceived mental exertion (RPME), (1-10) will be recored. Standardised scales measuring fatigue an sleep and a visual analogue scale specifically measuring tolerability will be used.
Timepoint [2] 325263 0
At the end of the 15 week program; with data also collected at the end of each 5 week block, and then within each component of the workouts.
Primary outcome [3] 325264 0
To determine the safety of the program.
Timepoint [3] 325264 0
Body chart discomfort scale to be measured after each work out. Adverse events will be continuously monitored.


Monitoring for adverse events will be from the first to the last workout session at the completion of the 15 week program.
Secondary outcome [1] 386367 0
Quantification of heart rate response during each workout, expressed as total time, and time as a percentage component of the total workout, spent at each gentile of the predicted maximum heart rate, 50-100%. Subjects will wear Polar monitors to continuously record heart rate during each workout; see figure two in the Protocol which illustrates the automatically recored heart rate data expressed as absolute heart rate, and percentage of predicted maximum heart rate.
Timepoint [1] 386367 0
Heart rate to be recorded with each workout.

Eligibility
Key inclusion criteria

Inclusion criteria
1. Established diagnosis of Parkinson’s Disease made by a neurologist using the UK Brain Bank criteria.
2. Willingness to participate in an exercise program.
3. Hoehn and Yahr scale 1 and 2.
4. No significant abnormality on cardiac stress testing.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Exclusion criteria.
1. Cognitive impairment prohibiting ability to follow complex commands.
2. Poorly controlled cardiovascular or respiratory disease that impacts on exercise.
3. Uncontrolled hypertension > 160/90.
4. Use of negative chrontotropic medications (such as beta-blockers) that impact of heart rate response to exercise.
5. Musculoskeletal deformities of hands, wrists or spine that would be exacerbated or cause undue pain when boxing.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Safety
Statistical methods / analysis
The outcome measures and observations are all descriptive and will be presented in tabular form.
Heart rate data from each session for each subject will be collated and presented in tabular form, expressed as time spent in each centile of maximum heart rate between 50-100%.
A key data point will be to identify the workout that consistently produce heart rate >80% of maximum.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
30/10/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17372 0
Perron Institute for Neurological and Translational Science - Nedlands
Recruitment postcode(s) [1] 31101 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 306603 0
Charities/Societies/Foundations
Name [1] 306603 0
Perron Institute for neurological and translational science
Country [1] 306603 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Perron Institute for Neurological and Translational Science
Address
8 Verdun St Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 307135 0
None
Name [1] 307135 0
None
Address [1] 307135 0
Country [1] 307135 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306788 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 306788 0
Ethics committee country [1] 306788 0
Australia
Date submitted for ethics approval [1] 306788 0
20/10/2020
Approval date [1] 306788 0
Ethics approval number [1] 306788 0

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

Contacts
Principal investigator
Name 105026 0
Prof David Blacker
Address 105026 0
C/O Perron Institute for Neurological and Translational Science
8 Verdun St NEDLANDS WA 6009
Country 105026 0
Australia
Phone 105026 0
+61 86547 0200
Fax 105026 0
Email 105026 0
[email protected]
Contact person for public queries
Name 105027 0
David Blacker
Address 105027 0
C/O Perron Institute for Neurological and Translational Science
8 Verdun St NEDLANDS WA 6009
Country 105027 0
Australia
Phone 105027 0
+61 86547 0200
Fax 105027 0
Email 105027 0
[email protected]
Contact person for scientific queries
Name 105028 0
David Blacker
Address 105028 0
C/O Perron Institute for Neurological and Translational Science
8 Verdun St NEDLANDS WA 6009
Country 105028 0
Australia
Phone 105028 0
+61 86547 0200
Fax 105028 0
Email 105028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data will be available
When will data be available (start and end dates)?
Data should be available from approximately October 2021; no end date.
Available to whom?
To researchers in the field upon request
Available for what types of analyses?
For meta-analysis, other research projects, after discussion with the chief investigator
How or where can data be obtained?
From the chief investigator; e-mail [email protected]


What supporting documents are/will be available?




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.