Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-22
Brief Title:
Modafinil and Exercise for Post Stroke Fatigue
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Modafinil and Exercise for Post Stroke Fatigue MODEX
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MODEX
Brief Summary:
A stroke happens when blood flow to the brain is stopped and the brain gets damaged At least half of people with a stroke have fatigue months and even years later A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life Though all the reasons for fatigue after stroke and how to best treat it are not fully understood the investigators think that fatigue results from the stroke changing the brain reducing physical fitness and decreasing muscle strength A stroke can also affect sleep and mood which can impact how people feel too It is also not known why women experience more fatigue than men after a stroke
Some studies have tested a drug called Modafinil for post stroke fatigue while other studies have tested exercise for it Yet there is unclear evidence for either treatment so this study has two main aims
1 Test if Exercise Program One is better than Exercise Program Two
2 Test if Modafinil is better than a Sugar Pill
As another aim the investigators will also look at if combining Modafinil with exercise has any benefits
This study will take place at 6 Canadian research sites to give a good representation of people after a stroke Each person will be tested on fatigue mood fitness thinking skills sleep and usual activity levels
Participants will be assigned at random like flipping a coin to 1 of 4 groups
1 Sugar Pill plus Exercise Program One
2 Sugar Pill plus Exercise Program Two
3 Modafinil plus Exercise Program One
4 Modafinil plus Exercise Program Two
The treatment will last 8 weeks The Modafinil or Sugar Pill will be taken once a day The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week Change in fatigue quality of life and other outcomes will be measured over 6 months
The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke
Some studies have tested a drug called Modafinil for post stroke fatigue while other studies have tested exercise for it Yet there is unclear evidence for either treatment so this study has two main aims
1 Test if Exercise Program One is better than Exercise Program Two
2 Test if Modafinil is better than a Sugar Pill
As another aim the investigators will also look at if combining Modafinil with exercise has any benefits
This study will take place at 6 Canadian research sites to give a good representation of people after a stroke Each person will be tested on fatigue mood fitness thinking skills sleep and usual activity levels
Participants will be assigned at random like flipping a coin to 1 of 4 groups
1 Sugar Pill plus Exercise Program One
2 Sugar Pill plus Exercise Program Two
3 Modafinil plus Exercise Program One
4 Modafinil plus Exercise Program Two
The treatment will last 8 weeks The Modafinil or Sugar Pill will be taken once a day The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week Change in fatigue quality of life and other outcomes will be measured over 6 months
The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke
Detailed Description:
Study Rationale
Post stroke fatigue PSF afflicts as many as 70 of the 400000 Canadians with stroke People with stroke endorse PSF as the most serious unmet research priority Pathological fatigue is not relieved by rest and is characterized by persistent or extreme tiredness exhaustion andor difficulty in initiating or sustaining voluntary activities PSF is an excellent exemplar to study as the cause of disabling PSF is unclear Systematic reviews confirm that PSF is multifactorial having both peripheral eg cardiovascular and neuromuscular and central eg alterations in brain function resulting in both physical and psychological symptoms components There are no evidence-based treatments for PSF however exercise and the dopaminergic medication Modafinil that targets the dopaminergic movement circuits in the brain have shown promise in alleviating symptoms in small studies
Study Design
This multicentre clinical trial will utilize a factorial design to quantify the effect of exercise or Modafinil 200 mg daily over 8 weeks on severity of fatigue symptoms It aims to recruit 224 participants into one of four arms It will also explore the interactions of Modafinil in combination with exercise and the effects of mood sleep stroke impairments activity level as measured by wearable devices sex and gender on outcomes
Study Population
Study participants must meet the inclusionexclusion criteria at the time of entry into the study In general participants will be 3 months post stroke onset ie intracerebral hemorrhage or ischemic stroke diagnosed by a physician at the time of consent into the study
Primary Hypothesis
There are two primary hypotheses based on outcomes at 8 weeks
1 Exercise Program One will improve fatigue symptom severity more than Exercise Program Two
2 Modafinil will improve fatigue symptom severity more than Placebo medication
Post stroke fatigue PSF afflicts as many as 70 of the 400000 Canadians with stroke People with stroke endorse PSF as the most serious unmet research priority Pathological fatigue is not relieved by rest and is characterized by persistent or extreme tiredness exhaustion andor difficulty in initiating or sustaining voluntary activities PSF is an excellent exemplar to study as the cause of disabling PSF is unclear Systematic reviews confirm that PSF is multifactorial having both peripheral eg cardiovascular and neuromuscular and central eg alterations in brain function resulting in both physical and psychological symptoms components There are no evidence-based treatments for PSF however exercise and the dopaminergic medication Modafinil that targets the dopaminergic movement circuits in the brain have shown promise in alleviating symptoms in small studies
Study Design
This multicentre clinical trial will utilize a factorial design to quantify the effect of exercise or Modafinil 200 mg daily over 8 weeks on severity of fatigue symptoms It aims to recruit 224 participants into one of four arms It will also explore the interactions of Modafinil in combination with exercise and the effects of mood sleep stroke impairments activity level as measured by wearable devices sex and gender on outcomes
Study Population
Study participants must meet the inclusionexclusion criteria at the time of entry into the study In general participants will be 3 months post stroke onset ie intracerebral hemorrhage or ischemic stroke diagnosed by a physician at the time of consent into the study
Primary Hypothesis
There are two primary hypotheses based on outcomes at 8 weeks
1 Exercise Program One will improve fatigue symptom severity more than Exercise Program Two
2 Modafinil will improve fatigue symptom severity more than Placebo medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MODEX2023 | OTHER | None | None |
| FRN183960 | OTHER_GRANT | None | None |
| CTO Project ID 4701 | OTHER | Clinical Trials Ontario | None |