Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600438
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Slowing Parkinsons Early Through Exercise Dosage - United Kingdom
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Slowing Parkinsons Early Through Exercise Dosage - United Kingdom
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Slow-SPEED-UK
Brief Summary:
Parkinsonamp39s disease PD is a condition in which parts of the brain become progressively damaged over many years The main symptoms of PD disease are involuntary shaking of parts of the body tremor stiffness and slow movement However research shows that people can also experience a range of other symptoms such as smell loss hyposmia sleep problems constipation depression and anxiety These features can be mild and generally occur many years before a person notices a change to their movement
Currently there is no proven way of preventing PD However it is possible that regular exercise might keep the symptoms at bay for a number of years This is because exercise can help protect brain cells from damage Regular movement also helps our brains adapt or rewire if one part becomes affected by disease This could mean living symptom-free for longer
Researchers in The Netherlands have developed a smartphone app known as the Slow-SPEED app It works by encouraging people to gradually increase their exercise level over a number of years Hopefully this will promote long-term changes to a persons lifestyle However the app has not yet been tested in a large enough group of people to say for certain whether it works
Queen Mary University of London is testing the Slow-SPEED app in a group of participants that have been recently diagnosed with PD The app is also being tested in people who do not have PD but may be at an increased risk of developing it in the future
Three groups of people are being recruited
1 Diagnosed with PD within the last three years
2 A reduced sense of smell known as hyposmia or anosmia diagnosed by a smell test
3 A condition called REM-sleep behavioural disorder diagnosed at a sleep clinic
Study participants will be asked to use the Slow-SPEED app for 3 years During this time information about their movement will be collected by a smartwatch Fitbit which is linked to the app in their smartphone Periodically health information will be collected through questionnaires movement tests eg tapping tests on a smartphone and smell tests Some participants will be invited to have blood tests but this is not necessary for everyone Most of these tests can be performed at home In addition there is an in-person visit at the beginning and end of study Combined these tests should give a comprehensive picture of how exercise might impact the early features of PD
Aims of the study
To test whether the Slow-SPEED app can successfully motivate people to increase their exercise level over several years
To determine whether exercise can prevent or reduce the early subtle changes associated with PD
Currently there is no proven way of preventing PD However it is possible that regular exercise might keep the symptoms at bay for a number of years This is because exercise can help protect brain cells from damage Regular movement also helps our brains adapt or rewire if one part becomes affected by disease This could mean living symptom-free for longer
Researchers in The Netherlands have developed a smartphone app known as the Slow-SPEED app It works by encouraging people to gradually increase their exercise level over a number of years Hopefully this will promote long-term changes to a persons lifestyle However the app has not yet been tested in a large enough group of people to say for certain whether it works
Queen Mary University of London is testing the Slow-SPEED app in a group of participants that have been recently diagnosed with PD The app is also being tested in people who do not have PD but may be at an increased risk of developing it in the future
Three groups of people are being recruited
1 Diagnosed with PD within the last three years
2 A reduced sense of smell known as hyposmia or anosmia diagnosed by a smell test
3 A condition called REM-sleep behavioural disorder diagnosed at a sleep clinic
Study participants will be asked to use the Slow-SPEED app for 3 years During this time information about their movement will be collected by a smartwatch Fitbit which is linked to the app in their smartphone Periodically health information will be collected through questionnaires movement tests eg tapping tests on a smartphone and smell tests Some participants will be invited to have blood tests but this is not necessary for everyone Most of these tests can be performed at home In addition there is an in-person visit at the beginning and end of study Combined these tests should give a comprehensive picture of how exercise might impact the early features of PD
Aims of the study
To test whether the Slow-SPEED app can successfully motivate people to increase their exercise level over several years
To determine whether exercise can prevent or reduce the early subtle changes associated with PD
Detailed Description:
Slow-SPEED-UK is a randomised controlled trial investigating the effects of an app-based exercise programme in earlyprodromal Parkinsons Disease PD The trial aims to recruit a total of 300 participants from the following cohorts i PD diagnosed in previous 3 years ii smell loss or iii REM-sleep behaviour disorder Participants will be identified and recruited from a large online observational trial known as PREDICT-PD
PREDICT-PD members meeting the inclusionexclusion criteria will be contacted via email or telephone The trial will be explained in detail and written information provided Interested participants will be sent an electronic consent form This only covers the first 4 weeks of the trial known as the baseline period Once consented a Welcome Pack is sent to the participants home address This contains instructions on installation of the Slow-SPEED app to their personal smartphone A Fitbit smartwatch is also provided
Participants are then asked to wear the Fitbit smartwatch for 4 weeks during which the step count is measured as they go about their normal activities Once completed those taking an average of more than 10000 stepsday will be excluded This is because it might not be safe to encourage highly active people to increase their exercise level
Eligible participants will be invited for a 3 hour in-person baseline visit where a second consent form covering the main study period will be issued A trained investigator will then review the medical history measure blood pressure and administer questionnaires covering a variety of early PD features Cognitive testing and smell testing are performed A subgroup of participants will also undergo blood draws For participants who are co-enrolled in the Parkinsonamp39s Progression Markers Initiative PPMI annual MRI data collected as part of this observational study will be reviewed
Participants can then begin using the app in their daily life Depending on their allocation to the treatment or active control arm they will be motivated to increase their exercise level by 100 or 10 respectively The encourages a gradual stepwise increase in physical activity Participants are welcome to partake in their preferred form of exercise Over the 3-year study period researchers will have access to continuous data recorded through their Fitbit including app usage heart rate step count and sleep quality A number of other assessments will be administered listed below
1 Movement tests - every 6 weeks participants complete a series of tests on their smartphone eg finger tapping shape drawing reaction time tasks 15 minutes in total
2 Questionnaires - participants are emailed an annual set of questionnaires regarding earlyprodromal PD symptoms
3 Axivity AX 6 - a wrist-worn accelerometer will be posted out annually Participants will wear it for 7-day bursts It records detailed information a participants movement
After 3 years subjects are invited for a second in-person visit All of the tests performed at the first visit will be repeated Participants are asked for feedback on the Slow-SPEED app At this point the study will be completed
Primarily Slow-SPEED-UK is a feasibility study aiming to determine whether participants will regularly and sustainably engage with a remote exercise programme irrespective of their symptom burden For our secondary outcomes the trial will generate a wealth of data collected regarding prodromalearly PD features These include measures of physical fitness eg resting heart rate non-motor features eg blood pressure constipation neuropsychiatric symptoms sleep quality smell loss motor deficits bradykinesia rigidity and tremor quality of life blood-based biomarkers and neuroimaging biomarkers where applicable The overarching hypothesis is that increasing exercise level will delay or slow the progression of these subtle early PD features
PREDICT-PD members meeting the inclusionexclusion criteria will be contacted via email or telephone The trial will be explained in detail and written information provided Interested participants will be sent an electronic consent form This only covers the first 4 weeks of the trial known as the baseline period Once consented a Welcome Pack is sent to the participants home address This contains instructions on installation of the Slow-SPEED app to their personal smartphone A Fitbit smartwatch is also provided
Participants are then asked to wear the Fitbit smartwatch for 4 weeks during which the step count is measured as they go about their normal activities Once completed those taking an average of more than 10000 stepsday will be excluded This is because it might not be safe to encourage highly active people to increase their exercise level
Eligible participants will be invited for a 3 hour in-person baseline visit where a second consent form covering the main study period will be issued A trained investigator will then review the medical history measure blood pressure and administer questionnaires covering a variety of early PD features Cognitive testing and smell testing are performed A subgroup of participants will also undergo blood draws For participants who are co-enrolled in the Parkinsonamp39s Progression Markers Initiative PPMI annual MRI data collected as part of this observational study will be reviewed
Participants can then begin using the app in their daily life Depending on their allocation to the treatment or active control arm they will be motivated to increase their exercise level by 100 or 10 respectively The encourages a gradual stepwise increase in physical activity Participants are welcome to partake in their preferred form of exercise Over the 3-year study period researchers will have access to continuous data recorded through their Fitbit including app usage heart rate step count and sleep quality A number of other assessments will be administered listed below
1 Movement tests - every 6 weeks participants complete a series of tests on their smartphone eg finger tapping shape drawing reaction time tasks 15 minutes in total
2 Questionnaires - participants are emailed an annual set of questionnaires regarding earlyprodromal PD symptoms
3 Axivity AX 6 - a wrist-worn accelerometer will be posted out annually Participants will wear it for 7-day bursts It records detailed information a participants movement
After 3 years subjects are invited for a second in-person visit All of the tests performed at the first visit will be repeated Participants are asked for feedback on the Slow-SPEED app At this point the study will be completed
Primarily Slow-SPEED-UK is a feasibility study aiming to determine whether participants will regularly and sustainably engage with a remote exercise programme irrespective of their symptom burden For our secondary outcomes the trial will generate a wealth of data collected regarding prodromalearly PD features These include measures of physical fitness eg resting heart rate non-motor features eg blood pressure constipation neuropsychiatric symptoms sleep quality smell loss motor deficits bradykinesia rigidity and tremor quality of life blood-based biomarkers and neuroimaging biomarkers where applicable The overarching hypothesis is that increasing exercise level will delay or slow the progression of these subtle early PD features
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