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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
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Scientific title
MITO-VATION - Feasibility of a Technology-supported Structured Home Exercise Program in Mitochondrial Disease?
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Secondary ID [1]
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2024_ETH00250
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mitochondrial Diseases
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Condition category
Condition code
Metabolic and Endocrine
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility - recruitment rate
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Assessment method [1]
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A recruitment rate of at least 50% of the people screened will be deemed feasible.
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Timepoint [1]
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8 weeks
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Primary outcome [2]
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Feasibility - retention rate
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Assessment method [2]
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A retention rate of 80% of participants will be deemed feasible.
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Timepoint [2]
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8 weeks
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Primary outcome [3]
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Feasibility - adherence to the exercise intervention
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Assessment method [3]
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An adherence to the exercise intervention is set at 75% to be deemed feasible.
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Timepoint [3]
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8 weeks
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Primary outcome [4]
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Acceptability of platforms used
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Assessment method [4]
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Acceptability subjective questionnaires will explore the intervention in terms of instructions given, useability and desirability of platforms used.
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Timepoint [4]
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8 weeks
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Secondary outcome [1]
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Physical performance test 1
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Assessment method [1]
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10 Meter Walking Speed - meters per second.
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Timepoint [1]
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8 weeks
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Secondary outcome [2]
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Physical performance test 2
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Assessment method [2]
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6-Minute Walk Test - distance walked in 6 minutes measured in meters over a 20 meter course.
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Timepoint [2]
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8 weeks
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Secondary outcome [3]
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Physical performance test 3
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Assessment method [3]
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5 Time Sit to Stand - time in seconds taken to perform 5 sit to stands from a standard height chair.
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Timepoint [3]
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8 weeks
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Secondary outcome [4]
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Physical performance test 4
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Assessment method [4]
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Grip Strength - isometric grip strength of both hands measured in kilograms.
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Timepoint [4]
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8 weeks
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Secondary outcome [5]
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Physical performance test 5
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Assessment method [5]
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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.
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Timepoint [5]
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8 weeks
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Secondary outcome [6]
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Subjective measure 1
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Assessment method [6]
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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.
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Timepoint [6]
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8 weeks
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Secondary outcome [7]
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Subjective measure 2
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Assessment method [7]
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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.
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Timepoint [7]
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8 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/09/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/02/2025
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Neuroscience Research Australia - Sydney
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Recruitment postcode(s) [1]
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2031 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Neuroscience Research Australia
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT06535646
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Carolyn M Sue, MBBS, PhD, FRACP
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Address
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Professor and Director, Kinghorn Chair, Neurodegeneration at NeuRA and Director of Neurosciences at POWH
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jeremey T Horne, Physiotherapy
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Address
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Country
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Phone
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+61293991835
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Fax
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Email
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[email protected]
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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
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