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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06535646




Registration number
NCT06535646
Ethics application status
Date submitted
11/07/2024
Date registered
2/08/2024
Date last updated
15/11/2024

Titles & IDs
Public title
Digital Health Technology for People With Mitochondrial Disease
Scientific title
MITO-VATION - Feasibility of a Technology-supported Structured Home Exercise Program in Mitochondrial Disease?
Secondary ID [1] 0 0
2024_ETH00250
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mitochondrial Diseases 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Home exercise program using Physitrack exercise program and a smart watch

Experimental: Home exercise program - All participants will be remotely monitored for 8-weeks, provided with a customised, structured home exercise program and activity monitor smart watch. Training volume will increase gradually. Participants will receive weekly, individualised emails supporting their exercise program, weekly telehealth coaching sessions and pre-programmed smart watch movement reminders.


Other interventions: Home exercise program using Physitrack exercise program and a smart watch
Participants wear a smart watch to monitor activity levels while using a web based exercise program to follow along for 8 weeks.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility - recruitment rate
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Feasibility - retention rate
Timepoint [2] 0 0
8 weeks
Primary outcome [3] 0 0
Feasibility - adherence to the exercise intervention
Timepoint [3] 0 0
8 weeks
Primary outcome [4] 0 0
Acceptability of platforms used
Timepoint [4] 0 0
8 weeks
Secondary outcome [1] 0 0
Physical performance test 1
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Physical performance test 2
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Physical performance test 3
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Physical performance test 4
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Physical performance test 5
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Subjective measure 1
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Subjective measure 2
Timepoint [7] 0 0
8 weeks

Eligibility
Key inclusion criteria
* =18 years of age
* Have a confirmed diagnosis of a PMD
* Be able to walk a minimum of 6 minutes with or without rest
* Provide written informed consent and
* Willingness and ability to comply with the study procedures
* Own a smart phone and be willing to download 2 apps
* internet access/telehealth app
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have atrial fibrillation or untreated symptomatic cardiac arrhythmia
* Non-English speaking
* Are pregnant
* Are wheelchair bound
* Have visual acuity less than 6/60 (Snellen Test)
* Other co-morbidities such as severe osteoarthritis, balance impairment, chronic obstructive pulmonary disease, cognitive impairment, depression and anything else that would impact on participant adherence, participant safety or interpretation of results.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Abstract: A lack of exercise combined with low levels of activity is prominent in people with Mitochondrial Disease (MD). Unfortunately, access to health professionals such as physiotherapists with experience in MD is difficult, especially in remote areas. The use of digital health technology (DHT) may be a feasible and acceptable way to remove access barriers while increasing participant compliance and self-efficacy with exercise. Given that the implementation of DHT to improve exercise compliance is scalable and inexpensive, it's important to test this intervention clinically. Objective: To determine the feasibility and acceptability of a structured home exercise program, supported by DHT, in people with MD. Methodology: Ten to 15 participants from the MD clinic at Neuroscience Research Australia will be recruited for this study. All participants will be remotely monitored for 8-weeks, provided with a customised, structured home exercise program and activity monitor smart watch. Training volume will increase gradually. Participants will receive weekly, individualised emails supporting their exercise program, weekly telehealth coaching sessions and pre-programmed smart watch movement reminders. Physical performance measures will be taken at week 0, pre-intervention and week 9, post-intervention. Questionnaires on fatigue, quality of life and acceptability of the program will also be administered. Results: Feasibility will be determined from the percentage of participants who enrol in the study from the eligible pool, percentage of dropouts over the study duration, and the percentage who adhere to the exercise program (defined as completing =75% of the regimen). Acceptability outcomes will be extracted from post-program questionnaires. Descriptive statistics of outcome measures (means and standard deviations) and any changes from pre to post will also be calculated. Conclusion: If shown to be feasible and acceptable, this intervention has the potential to deliver a significant impact on the lives of individuals with MD and the wider MD community.
Trial website
https://clinicaltrials.gov/study/NCT06535646
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carolyn M Sue, MBBS, PhD, FRACP
Address 0 0
Professor and Director, Kinghorn Chair, Neurodegeneration at NeuRA and Director of Neurosciences at POWH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jeremey T Horne, Physiotherapy
Address 0 0
Country 0 0
Phone 0 0
+61293991835
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06535646