MITO-VATION - Feasibility of a Technology-supported Structured Home Exercise Program in Mitochondrial Disease?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Feasibility - recruitment rate
Study Overview
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.
Detailed Description
Feasibility study
Baseline measurements taken at: week 0 = pre-intervention, Outcome measurements taken at: week 9 = post-intervention assessment
Feasibility outcomes:
- the percentage of participants who enrol in the study from the eligible pool
- percentage of dropouts over the study duration
- Compliance to the exercise program and use of DHT:
- daily step count goal met from Garmin smart watch data over 56 days expressed as a percentage.
- weekly intensity minute's goal met from Garmin smart watch over 8 weeks expressed as a percentage.
- Strength training adherence (from exercise diary) expressed as a percentage of the prescription (3 sessions per week over 8 weeks or 24 planned sessions).
- Participation in telehealth sessions, expressed as a percentage of the overall prescription (8 telehealth sessions over the 8-week intervention).
- Wearing of the smart watch (Garmin) for 8 consecutive weeks (56 days), expressed as a percentage of total wear time (24 hours a day, 7 days a week (excluding showering and recharging of device).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
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.
Intervention: Home exercise program using Physitrack exercise program and a smart watch (Other)
Outcomes
Primary Outcomes
Feasibility - recruitment rate
Time Frame: 8 weeks
A recruitment rate of at least 50% of the people screened will be deemed feasible.
Feasibility - retention rate
Time Frame: 8 weeks
A retention rate of 80% of participants will be deemed feasible.
Feasibility - adherence to the exercise intervention
Time Frame: 8 weeks
An adherence to the exercise intervention is set at 75% to be deemed feasible.
Acceptability of platforms used
Time Frame: 8 weeks
Acceptability subjective questionnaires will explore the intervention in terms of instructions given, useability and desirability of platforms used.
Secondary Outcomes
- Physical performance test 3(8 weeks)
- Physical performance test 1(8 weeks)
- Physical performance test 2(8 weeks)
- Physical performance test 5(8 weeks)
- Subjective measure 1(8 weeks)
- Physical performance test 4(8 weeks)
- Subjective measure 2(8 weeks)