Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535646
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Digital Health Technology for People With Mitochondrial Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MITO-VATION - Feasibility of a Technology-supported Structured Home Exercise Program in Mitochondrial Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 its 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
1 the percentage of participants who enrol in the study from the eligible pool
2 percentage of dropouts over the study duration
3 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 minutes 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
Compliance is defined as having met 75 or greater of prescribed activity Acceptability outcomes will be extracted from post-program questionnaires
Secondary outcomes
10 Meter Walking Speed - assesses walking speed in meters per second over a short duration
6-Minute Walk Test - walking endurance distance walked in meters over 6 minutes
5 Time Sit to Stand - lower limb strength time in seconds taken to perform 5 sit to stands from a standard height chair 43 to 45cm
Grip Strength - hand isometric grip strength contraction held for 3-5 seconds measuring grip strength in kilograms
Berg Balance Test - 14-item scale designed to measure balance scored out of 56
Fatigue Impact Scale - self-reported questionnaire evaluating the effect of fatigue on three domains of daily life cognitive functioning physical functioning and psychosocial functioning 40 items each scored 0 no problem to 4 extreme problem providing a continuous scale of 0-160
Newcastle Mitochondrial Disease Adult Scale - rating scale to monitor the progression of a PMD Sections 1 2 are self-rated while section 3 is rated by a neurologist
Home Exercise Program All participants will be provided with a structured home exercise program which is customised according to the participants baseline activity measures obtained from smart watch data over 1 week pre-intervention week 0 This home exercise program is undertaken using the supplied smart watch Garmin Physitrack app and elastic bands An education session on how to use the training equipment will be conducted week 1- start of intervention appointment at Neuroscience Research Australia NeuRA A narrated video of the exercise program will also be sent to participants via email through the Physitrack app A hard copy version of the exercise program will be supplied to participants along with an exercise diary at the week 1 start of intervention appointment
The home exercise intervention will last 8 weeks and consist of
1 A daily step target goal
2 A weekly intensity minutes target goal
3 Major muscle group strengthening using the supplied equipment
Daily step target
Participants will attempt to increase their daily step count by 10 each week from baseline until an increase of 50 is achieved at week 5 This volume will be then maintained or increased as tolerated for the remaining 3 weeks until the intervention ends The means by which daily step count is achieved is up to the participant ie planned walk or increased habitual walking activity Participants will be able to view live on their smart watch or via Garmin Connect app how many steps they have taken at any time to help them meet their daily step target
Intensity minutes target goal
Intensity minutes are earned based on a participants current heart rate when compared to their average resting heart rate Intensity minutes are earned once increased activity is detected by the smart watch Participants age weight height and resting heart rate calculated by the Garmin device also factor into intensity minutes Participants will attempt to increase their weekly intensity minutes score by 10 each week from baseline until an increase of 50 is achieved at week 5 This volume will be then maintained or increased as tolerated for the remaining 3 weeks until the intervention ends
Strength training
Each home strength training session 3 per week will start with a short warm up ie 5-min walk to be followed by 6 stretching exercises targeting the lower limb upper limb and spine
Once warmed up participants will perform a circuit of 8 exercises with the help of the Physitrack app or hard-copy exercise program It will involve large muscle groups in the following order ie alternating arm and leg exercises to minimise muscle soreness and fatigue
1 Lunges
2 Row
3 Sit to stand
4 Chest press
5 Hip abduction
6 Trunk rotation
7 Hip extension
8 Heel raise
Sets and repetitions for each participant along with training intensity ie elastic band resistance will be determined using pre-intervention assessment baseline data during the face-to-face meeting at the beginning of week 1 The modified Borg rating of perceived exertion scale 1 to 10 will be used where a score of 6 ie able to speak 3 to 5 words comfortably being the starting level Once a score of 5 ie able to speak more than 5 words comfortably or less is perceived the band resistance will be raised to the next level The circuit of 8 exercises will consist of 1 to 3 rounds of single sets 10 to 20 repetitions to allow full muscle group recovery in between The speed of repetitions will focus on having a controlled concentriceccentric portion of the movement The training volume sets x reps x band resistance will be increased by 10 per week for 5 weeks and then maintained or increased as tolerated for a further 3 weeks The volume targets will be emailed to participants weekly through the Physitrack app Targets will also be discussed at the weekly telehealth session
Participants will complete a supplied daily exercise diary for monitoring of adherence to the prescribed exercise program
Telehealth coaching sessions
Eight weekly telehealth meetings will take place at a time that is suitable for the study participant starting week 1 and continue through to week 8 of the study Each session will last 10 to 20 minutes via phone using the Physi app or through an email link to a home computer The aim of each meeting will be to monitor participant progress and troubleshoot any barriers or unforeseen difficulties that may arise across the week to maintain motivation for exercise Health coaching strategies will be used such as
use of a health coaching log form
setting clear goals
establishing a trusting relationship
using active listening and questioning techniques
providing constructive feedback
support to encourage independence in exercising
adaptability and flexibility to tailor the session to meet the needs and preferences of each individual participant In instances where technical difficulties prevent a participant from being able to log in to a telehealth session it may still be conducted over the phone
Physitrack health coaching email messages Physitrack is an exercise prescription app which allows remote contact between therapists and their patients Participants will need to download the Physitrack app onto their phones to be able to receive weekly emails and participate in weekly telehealth meetings Personalised emails will be sent from Physitrack to participants at the beginning of each week and consist of encouraging messages and reminders of the benefits of exercise They will also include fully narrated exercise videos so participants will have a clear understanding of their exercise program and goals each week They will be scheduled to be sent to the participants email each Monday morning between weeks 2 and 8 of the study In the case of week 1 the email will be sent after the activity data has been downloaded and reviewed by the investigator at the week 1 start of intervention meeting that will occur in-person
Activity monitoring
All participants will have their activity monitored 24 hours a day 7 days a week excluding showering and device recharging for 8 weeks using a smart watch Garmin The smart watch will record activity during and outside of the personalised home exercise program Participants will be provided with the smart watch at the conclusion of the pre-intervention meeting week 0 to wear for one week to determine baseline activity levels This data will be downloaded at the study visits at the beginning of week 1 start of intervention meeting and post-intervention assessment at the beginning of week 9 Participants will download the Garmin Connect app onto their smartphone and transfer data daily to avoid any potential loss of information The metrics downloaded will include
Steps taken per day
Average heart rate
Intensity minutes
Hours of sleep per day
A brief 5 minute training session will be held at the end of the pre-intervention visit to teach the participants how to wear charge and operate the smart watch A more detailed training session will be held at the week 1 start-intervention visit to NeuRA Participants will be taught how to use the smart watch and Garmin Connect app to self-monitor their daily activity levels and work toward meeting their daily and weekly activity goals
STUDY GROUPS
Single group pre-post feasibility study Participants will be those with a primary diagnosis of PMD who attend the PMD clinic at Neuroscience Research Australia NeuRA Participants will attend 3 study appointments at the following time points
Pre-intervention - week 0 for initial assessment of baseline objective and subjective measures provision of a smart watch Garmin education on its use and downloading of the Garmin Connect app onto participants phones The watch is worn continuously for 1 week before returning for the next face to face meeting where baseline activity data will be downloaded for review
Start-intervention - beginning of week 1 for downloading of 1 week of pre-intervention activity data to set exercise targets Education on performing the prescribed home exercise program including use of supplied equipment smart watch elastic bands exercise diary The home exercise program will be provided both electronically using the Physitrack app downloaded onto participants phones and in hard copy via an exercise diary for participants to fill in as required
Post-intervention - beginning of week 9 for reassessment of measures conducted at the pre-intervention assessment week 0 Downloading of 8 weeks of participant activity data from their Garmin Connect app Gain feedback on program acceptability from participants via questionnaires which will contain questions regarding the home exercise experience smart watch telehealth and Physitrack use
NUMBER OF PARTICIPANTS This study will recruit 10 participants with a PMD over a 5-month period
NUMBER OF CENTRES
This study will be conducted at a single site NeuRA Randwick NSW
This study will be completed over a 1-year period 5-months recruitment a 5-month trial period and 2-months to analyse and report the results The expected start date is July 2024
Baseline measurements taken at week 0 pre-intervention Outcome measurements taken at week 9 post-intervention assessment
Feasibility outcomes
1 the percentage of participants who enrol in the study from the eligible pool
2 percentage of dropouts over the study duration
3 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 minutes 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
Compliance is defined as having met 75 or greater of prescribed activity Acceptability outcomes will be extracted from post-program questionnaires
Secondary outcomes
10 Meter Walking Speed - assesses walking speed in meters per second over a short duration
6-Minute Walk Test - walking endurance distance walked in meters over 6 minutes
5 Time Sit to Stand - lower limb strength time in seconds taken to perform 5 sit to stands from a standard height chair 43 to 45cm
Grip Strength - hand isometric grip strength contraction held for 3-5 seconds measuring grip strength in kilograms
Berg Balance Test - 14-item scale designed to measure balance scored out of 56
Fatigue Impact Scale - self-reported questionnaire evaluating the effect of fatigue on three domains of daily life cognitive functioning physical functioning and psychosocial functioning 40 items each scored 0 no problem to 4 extreme problem providing a continuous scale of 0-160
Newcastle Mitochondrial Disease Adult Scale - rating scale to monitor the progression of a PMD Sections 1 2 are self-rated while section 3 is rated by a neurologist
Home Exercise Program All participants will be provided with a structured home exercise program which is customised according to the participants baseline activity measures obtained from smart watch data over 1 week pre-intervention week 0 This home exercise program is undertaken using the supplied smart watch Garmin Physitrack app and elastic bands An education session on how to use the training equipment will be conducted week 1- start of intervention appointment at Neuroscience Research Australia NeuRA A narrated video of the exercise program will also be sent to participants via email through the Physitrack app A hard copy version of the exercise program will be supplied to participants along with an exercise diary at the week 1 start of intervention appointment
The home exercise intervention will last 8 weeks and consist of
1 A daily step target goal
2 A weekly intensity minutes target goal
3 Major muscle group strengthening using the supplied equipment
Daily step target
Participants will attempt to increase their daily step count by 10 each week from baseline until an increase of 50 is achieved at week 5 This volume will be then maintained or increased as tolerated for the remaining 3 weeks until the intervention ends The means by which daily step count is achieved is up to the participant ie planned walk or increased habitual walking activity Participants will be able to view live on their smart watch or via Garmin Connect app how many steps they have taken at any time to help them meet their daily step target
Intensity minutes target goal
Intensity minutes are earned based on a participants current heart rate when compared to their average resting heart rate Intensity minutes are earned once increased activity is detected by the smart watch Participants age weight height and resting heart rate calculated by the Garmin device also factor into intensity minutes Participants will attempt to increase their weekly intensity minutes score by 10 each week from baseline until an increase of 50 is achieved at week 5 This volume will be then maintained or increased as tolerated for the remaining 3 weeks until the intervention ends
Strength training
Each home strength training session 3 per week will start with a short warm up ie 5-min walk to be followed by 6 stretching exercises targeting the lower limb upper limb and spine
Once warmed up participants will perform a circuit of 8 exercises with the help of the Physitrack app or hard-copy exercise program It will involve large muscle groups in the following order ie alternating arm and leg exercises to minimise muscle soreness and fatigue
1 Lunges
2 Row
3 Sit to stand
4 Chest press
5 Hip abduction
6 Trunk rotation
7 Hip extension
8 Heel raise
Sets and repetitions for each participant along with training intensity ie elastic band resistance will be determined using pre-intervention assessment baseline data during the face-to-face meeting at the beginning of week 1 The modified Borg rating of perceived exertion scale 1 to 10 will be used where a score of 6 ie able to speak 3 to 5 words comfortably being the starting level Once a score of 5 ie able to speak more than 5 words comfortably or less is perceived the band resistance will be raised to the next level The circuit of 8 exercises will consist of 1 to 3 rounds of single sets 10 to 20 repetitions to allow full muscle group recovery in between The speed of repetitions will focus on having a controlled concentriceccentric portion of the movement The training volume sets x reps x band resistance will be increased by 10 per week for 5 weeks and then maintained or increased as tolerated for a further 3 weeks The volume targets will be emailed to participants weekly through the Physitrack app Targets will also be discussed at the weekly telehealth session
Participants will complete a supplied daily exercise diary for monitoring of adherence to the prescribed exercise program
Telehealth coaching sessions
Eight weekly telehealth meetings will take place at a time that is suitable for the study participant starting week 1 and continue through to week 8 of the study Each session will last 10 to 20 minutes via phone using the Physi app or through an email link to a home computer The aim of each meeting will be to monitor participant progress and troubleshoot any barriers or unforeseen difficulties that may arise across the week to maintain motivation for exercise Health coaching strategies will be used such as
use of a health coaching log form
setting clear goals
establishing a trusting relationship
using active listening and questioning techniques
providing constructive feedback
support to encourage independence in exercising
adaptability and flexibility to tailor the session to meet the needs and preferences of each individual participant In instances where technical difficulties prevent a participant from being able to log in to a telehealth session it may still be conducted over the phone
Physitrack health coaching email messages Physitrack is an exercise prescription app which allows remote contact between therapists and their patients Participants will need to download the Physitrack app onto their phones to be able to receive weekly emails and participate in weekly telehealth meetings Personalised emails will be sent from Physitrack to participants at the beginning of each week and consist of encouraging messages and reminders of the benefits of exercise They will also include fully narrated exercise videos so participants will have a clear understanding of their exercise program and goals each week They will be scheduled to be sent to the participants email each Monday morning between weeks 2 and 8 of the study In the case of week 1 the email will be sent after the activity data has been downloaded and reviewed by the investigator at the week 1 start of intervention meeting that will occur in-person
Activity monitoring
All participants will have their activity monitored 24 hours a day 7 days a week excluding showering and device recharging for 8 weeks using a smart watch Garmin The smart watch will record activity during and outside of the personalised home exercise program Participants will be provided with the smart watch at the conclusion of the pre-intervention meeting week 0 to wear for one week to determine baseline activity levels This data will be downloaded at the study visits at the beginning of week 1 start of intervention meeting and post-intervention assessment at the beginning of week 9 Participants will download the Garmin Connect app onto their smartphone and transfer data daily to avoid any potential loss of information The metrics downloaded will include
Steps taken per day
Average heart rate
Intensity minutes
Hours of sleep per day
A brief 5 minute training session will be held at the end of the pre-intervention visit to teach the participants how to wear charge and operate the smart watch A more detailed training session will be held at the week 1 start-intervention visit to NeuRA Participants will be taught how to use the smart watch and Garmin Connect app to self-monitor their daily activity levels and work toward meeting their daily and weekly activity goals
STUDY GROUPS
Single group pre-post feasibility study Participants will be those with a primary diagnosis of PMD who attend the PMD clinic at Neuroscience Research Australia NeuRA Participants will attend 3 study appointments at the following time points
Pre-intervention - week 0 for initial assessment of baseline objective and subjective measures provision of a smart watch Garmin education on its use and downloading of the Garmin Connect app onto participants phones The watch is worn continuously for 1 week before returning for the next face to face meeting where baseline activity data will be downloaded for review
Start-intervention - beginning of week 1 for downloading of 1 week of pre-intervention activity data to set exercise targets Education on performing the prescribed home exercise program including use of supplied equipment smart watch elastic bands exercise diary The home exercise program will be provided both electronically using the Physitrack app downloaded onto participants phones and in hard copy via an exercise diary for participants to fill in as required
Post-intervention - beginning of week 9 for reassessment of measures conducted at the pre-intervention assessment week 0 Downloading of 8 weeks of participant activity data from their Garmin Connect app Gain feedback on program acceptability from participants via questionnaires which will contain questions regarding the home exercise experience smart watch telehealth and Physitrack use
NUMBER OF PARTICIPANTS This study will recruit 10 participants with a PMD over a 5-month period
NUMBER OF CENTRES
This study will be conducted at a single site NeuRA Randwick NSW
This study will be completed over a 1-year period 5-months recruitment a 5-month trial period and 2-months to analyse and report the results The expected start date is July 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None