Digital Health Technology for People With Mitochondrial Disease
NCT Number: NCT06535646
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mitochondrial Diseases
Interventions: OTHER: Home exercise program using Physitrack exercise program and a smart watch
Sponsor: Neuroscience Research Australia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-24
Completion Date: 2025-01-24

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.

Primary Outcome Measures: 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 intervention, An adherence to the exercise intervention is set at 75% to be deemed feasible., 8 weeks|Acceptability, Acceptability questionnaires will explore the intervention., 8 weeks
Secondary Outcome Measures: Physical performance test 1, 10 Meter Walking Speed - meters per second., 8 weeks|Physical performance test 2, 6-Minute Walk Test - distance walked in 6 minutes measured in meters over a 20 meter course., 8 weeks|Physical performance test 3, 5 Time Sit to Stand - time in seconds taken to perform 5 sit to stands from a standard height chair., 8 weeks|Physical performance test 4, Grip Strength - isometric grip strength of both hands measured in kilograms., 8 weeks|Physical performance test 5, 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., 8 weeks|Subjective measure 1, 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., 8 weeks|Subjective measure 2, 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., 8 weeks