Digital Health Technology for People With Mitochondrial Disease

NCT06535646 | Completed

• 1 other identifier: 2024_ETH00250
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Diseases

Outcome Measures

Primary Outcomes (4)

• Feasibility - recruitment rate

  A recruitment rate of at least 50% of the people screened will be deemed feasible.

  8 weeks

• Feasibility - retention rate

  A retention rate of 80% of participants will be deemed feasible.

  8 weeks

• Feasibility - adherence to the exercise intervention

  An adherence to the exercise intervention is set at 75% to be deemed feasible.

  8 weeks

• Acceptability of platforms used

  Acceptability subjective questionnaires will explore the intervention in terms of instructions given, useability and desirability of platforms used.

  8 weeks

Secondary Outcomes (7)

• Physical performance test 1

  8 weeks

• Physical performance test 2

  8 weeks

• Physical performance test 3

  8 weeks

• Physical performance test 4

  8 weeks

• Physical performance test 5

  8 weeks

Study Arms (1)

Home exercise program

EXPERIMENTAL

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: Home exercise program using Physitrack exercise program and a smart watch

Interventions

Home exercise program using Physitrack exercise program and a smart watch OTHER

Participants wear a smart watch to monitor activity levels while using a web based exercise program to follow along for 8 weeks.

Home exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuroscience Research Australia: lead

Study Sites (1)

Neuroscience Research Australia

Sydney, New South Wales, 2031, Australia

Location

Related Publications (1)

• https://pmc.ncbi.nlm.nih.gov/articles/PMC12944747/

  RESULT

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carolyn M Sue, MBBS, PhD, FRACP

  Professor and Director, Kinghorn Chair, Neurodegeneration at NeuRA and Director of Neurosciences at POWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 2, 2024
• Study Start: August 9, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)