Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001334695
Ethics application status
Approved
Date submitted
28/11/2023
Date registered
19/12/2023
Date last updated
11/08/2024
Date data sharing statement initially provided
19/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and acceptability of practical, individualised, high intensity aerobic exercise in people with Parkinson's disease.
Scientific title
The feasibility and acceptability of pragmatic, individualised, high intensity aerobic exercise in people with Parkinson's disease.
Secondary ID [1] 311054 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 332173 0
Condition category
Condition code
Neurological 328890 328890 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 328892 328892 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will undertake individualised high intensity aerobic exercise 3 times per week for 6 to 12 months. The exercise will consist of one or a combination of the following:
• high intensity continuous aerobic exercise for 30 min at 75 to 85% HRmax or equivalent;
• high intensity interval training involving 4 x 4 min at 85 to 95% HRmax or equivalent, with 3 min active recovery between intervals;
• All exercise will include 5 to 10 mins of aerobic exercise warm-up and 5 mins of cool-down.

High intensity aerobic exercise will be delivered via different modalities (e.g., fast walking/jogging/running on a treadmill or overground, cycling, elliptical cross-training, rowing, stair climbing) and delivered at home and/or in the community (e.g., local park or gym) based on individual preferences and suitability. Participants may choose one or a combination of different aerobic exercises and change their exercise modality/delivery for the duration of the trial as long as they maintain compliance to the high intensity training prescription (i.e., remain in their high intensity training zone). Participants’ high intensity training prescription will be calculated using results from their graded exercise test as per routine practice for clinical exercise specialists. Compliance with exercise intensity during exercise (achieving and maintaining high intensity targets) will be via HR sensor (Polar H9 or equivalent) and perceived exertion using a Rating of Perceived Exertion scale regularly during their exercise.

A physiotherapist or exercise physiologist will visit participants in their homes and/or community at the start of the trial to set up their individualised, high intensity aerobic exercise program. The physiotherapist/exercise physiologist will supervise the participants, monitor their exercise responses, and progress the exercise until they meet their target training prescription and are safe to exercise independently. They will be provided with written and/or pictorial instructions for their exercise. Another visit will be performed at midway (month 3) to ensure participants are exercising appropriately. Participants may receive up to four home visits during the intervention period.

Participants will be remotely supervised via weekly phone/video calls for month 1, fortnightly for months 2 and 3, then monthly for months 4 to 6. A physiotherapist or exercise physiologist will also monitor participants’ adherence and progress with the aerobic exercise program using cloud-based applications (e.g., University of Sydney OneDrive, Polar app) shared between the physiotherapist/exercise physiologist and each participant. Participants will be asked to complete an exercise diary (digital or paper) documenting the number, duration, and intensity of exercise sessions completed.

Participants will also be provided with tailored health coaching by a physiotherapist or exercise physiologist during the phone/video calls, which incorporates behaviour change techniques to facilitate self-management and adherence to exercise. Behavioural change techniques may include education on the benefits of exercise in the management of PD, identifying and addressing barriers to exercise, goal setting, action planning, providing individualised feedback, reinforcement of behavioural progress, and facilitating self-monitoring of behaviour and outcomes.

Participant supervision and health coaching will be graded, i.e., frequent supervision and coaching at the start of the intervention which are gradually withdrawn as participants become familiar with exercise and develop self-management skills. During follow-up (month 7 to 12), participants will be asked to continue their high intensity aerobic exercise program using their most recently prescribed exercise plan from the end of the intervention period (month 6). Participants will not receive any health monitoring and coaching during follow-up.
Intervention code [1] 327500 0
Rehabilitation
Intervention code [2] 327501 0
Lifestyle
Intervention code [3] 327502 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336704 0
Feasibility
Timepoint [1] 336704 0
Baseline (month 0), post intervention (month 6 post baseline), and follow up (month 12 post baseline)
Primary outcome [2] 336705 0
Acceptability
Timepoint [2] 336705 0
Post intervention (month 6 post baseline) and follow up (month 12 post baseline)
Secondary outcome [1] 429372 0
Parkinson's disease severity and progression
Timepoint [1] 429372 0
Baseline (month 0), post intervention (month 6 post baseline), and follow up (month 12 post baseline)
Secondary outcome [2] 429373 0
Exercise self-efficacy
Timepoint [2] 429373 0
Baseline (month 0), post intervention (month 6 post baseline), and follow up (month 12 post baseline)
Secondary outcome [3] 429374 0
Physical activity
Timepoint [3] 429374 0
Baseline (month 0), post intervention (month 6 post baseline), and follow up (month 12 post baseline)
Secondary outcome [4] 429375 0
Impact of Parkinson's disease on activities of daily living
Timepoint [4] 429375 0
Baseline (month 0), post intervention (month 6 post baseline), and follow up (month 12 post baseline)
Secondary outcome [5] 429376 0
Aerobic capacity
Timepoint [5] 429376 0
Baseline (month 0), post intervention (month 6 post baseline), and follow up (month 12 post baseline)
Secondary outcome [6] 429377 0
Parkinson's disease severity and progression (for a subset of participants, n=2)
Timepoint [6] 429377 0
Baseline (month 0), post intervention (month 6 post baseline), and follow up (month 12 post baseline)

Eligibility
Key inclusion criteria
- Adults aged 40 years and over with mild idiopathic Parkinson's disease (Hoehn & Yahr less than or equal to 2), diagnosed for 5 years or less.
- Stable dopaminergic medication regimen for at least 4 weeks prior to commencement of study (if on medication).
- Able to walk independently without an aid.
- Lives in the Sydney metropolitan area.

There are no additional inclusion criteria for the subset of participants (n=2) who will undertake the Total Body PET/CT scans.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Medical conditions which would preclude or interfere with study safety and interpretation (e.g., uncontrolled cardiopulmonary, metabolic, musculoskeletal, orthopaedic, and/or psychiatric diseases; undergoing active treatment for cancer; coronary artery disease, myocardial infarction and/or surgery; Type I diabetes; recent stroke or transient ischaemic attack; neurological conditions other than idiopathic Parkinson's disease).
- On beta-blocker medications.
- Cognitive impairment (Telephone Interview for Cognitive Status – Modified less than 21).
- Currently reported performing 30 min or more of high intensity aerobic exercise per week.
- Receiving deep brain stimulation.

Additional exclusion criteria for a subset of participants (n=2) who will undertake the Total Body PET/CT scans:
- Women lactating, pregnant, or of childbearing age who are aiming to fall pregnant during the study
- History of glaucoma, retinal, and/or macular disease.
- Received anti-Vascular Endothelial Growth Factor monoclonal antibody therapy the 3 months prior to recruitment.
- On carbonic anhydrase inhibitors.
- Claustrophobia
- Morbid obesity with body weight over 227kg

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative outcomes will be explored descriptively using means (SD) or median (IQR) based on data distribution of continuous outcomes, and n (%) for discrete outcomes. Visual inspection of Total Body PET/CT will also be performed, along with parametric statistical analysis of quantitative parameters (standardised uptake value ratio (SUVR) and pharmacokinetic modelling parameters).

Qualitative data will be explored through inductive thematic analysis of the interview data. The interview data will also be used to help with interpretation of the quantitative results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
21/06/2024
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
14
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315311 0
University
Name [1] 315311 0
University of Sydney (New Academic Staff Support Package, Faculty of Medicine and Health)
Country [1] 315311 0
Australia
Funding source category [2] 315315 0
University
Name [2] 315315 0
University of Sydney (Total Body PET Pilot Seeding Funding Scheme, Sydney Imaging)
Country [2] 315315 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Western Avenue, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 317365 0
None
Name [1] 317365 0
Address [1] 317365 0
Country [1] 317365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314234 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314234 0
Ethics committee country [1] 314234 0
Australia
Date submitted for ethics approval [1] 314234 0
07/11/2023
Approval date [1] 314234 0
01/03/2024
Ethics approval number [1] 314234 0

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

Contacts
Principal investigator
Name 130886 0
Dr Lina Goh
Address 130886 0
University of Sydney, Level 7 East, D18 Susan Wakil Health Building, Western Avenue, Camperdown NSW 2050
Country 130886 0
Australia
Phone 130886 0
+61 2 9351 9566
Fax 130886 0
Email 130886 0
lina.goh@sydney.edu.au
Contact person for public queries
Name 130887 0
Lina Goh
Address 130887 0
University of Sydney, Level 7 East, D18 Susan Wakil Health Building, Western Avenue, Camperdown NSW 2050
Country 130887 0
Australia
Phone 130887 0
+61 2 9351 9566
Fax 130887 0
Email 130887 0
lina.goh@sydney.edu.au
Contact person for scientific queries
Name 130888 0
Lina Goh
Address 130888 0
University of Sydney, Level 7 East, D18 Susan Wakil Health Building, Western Avenue, Camperdown NSW 2050
Country 130888 0
Australia
Phone 130888 0
+61 2 9351 9566
Fax 130888 0
Email 130888 0
lina.goh@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.