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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

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
Assessment method [1] 0 0
A recruitment rate of at least 50% of the people screened will be deemed feasible.
Timepoint [1] 0 0
8 weeks
Primary outcome [2] 0 0
Feasibility - retention rate
Assessment method [2] 0 0
A retention rate of 80% of participants will be deemed feasible.
Timepoint [2] 0 0
8 weeks
Primary outcome [3] 0 0
Feasibility - adherence to the exercise intervention
Assessment method [3] 0 0
An adherence to the exercise intervention is set at 75% to be deemed feasible.
Timepoint [3] 0 0
8 weeks
Primary outcome [4] 0 0
Acceptability of platforms used
Assessment method [4] 0 0
Acceptability subjective questionnaires will explore the intervention in terms of instructions given, useability and desirability of platforms used.
Timepoint [4] 0 0
8 weeks
Secondary outcome [1] 0 0
Physical performance test 1
Assessment method [1] 0 0
10 Meter Walking Speed - meters per second.
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Physical performance test 2
Assessment method [2] 0 0
6-Minute Walk Test - distance walked in 6 minutes measured in meters over a 20 meter course.
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Physical performance test 3
Assessment method [3] 0 0
5 Time Sit to Stand - time in seconds taken to perform 5 sit to stands from a standard height chair.
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Physical performance test 4
Assessment method [4] 0 0
Grip Strength - isometric grip strength of both hands measured in kilograms.
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Physical performance test 5
Assessment method [5] 0 0
Berg Balance Test - 14-item scale measuring balance. Scored on a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion. A high score correlates to better balance.
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Subjective measure 1
Assessment method [6] 0 0
Fatigue Impact Scale - self-reported questionnaire on fatigue, 40 items, each scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. A high score equates to greater fatigue.
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Subjective measure 2
Assessment method [7] 0 0
Newcastle Mitochondrial Disease Adult Scale - monitors disease progression Section 1 - rates current function according to the patient, 10 questions rated 0 to 5 with 0 being normal and 5 unable to do. Section 2 - this 9 item section rates system specific involvement from 0 (no past history) to 5 (significant history) according to the patient interview, clinician's knowledge of the patient and the clinical notes. Section 3 - rates the patient's current status according to the examination performed by the rater. Scores are assigned according to the clinician's judgement. This 10 question section is rated 0 to 5 with 0 being none and 5 being severe. A final total score is calculated by simply summing the scores obtained for each section. The higher the score the more severe the disease. Total scores can range from 0 to 145.
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
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
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
Email 0 0
j.horne@neura.edu.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06535646