Back to resultsFluoxetine Opens Window to Improve Motor Recovery After Stroke (FLOW)
Primary Purpose
Stroke, Cerebrovascular Accident, Cerebral Infarction
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fluoxetine Hydrochloride
Placebo
Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Exercise, Fluoxetine, Randomized Control Trial, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- 25 years of age or older
- Days post stroke must be between 2 to 12 months when enrolled (i.e. day of consent)
- Patient-reported hemiparesis of the lower extremity
Exclusion Criteria:
- Patients with subarachnoid hemorrhage
- Pre-morbid modified Rankin score > 2
- Substantial premorbid disability or pre-existing deficit or language comprehension deficit that could interfere with assessments
- Diagnosis of major depressive disorder/anxiety disorder requiring antidepressant use within 6 weeks of enrolment
- Taking neuroleptic drugs, benzodiazepines, monoamine oxidase inhibitors within 30 days of enrolment
- Unstable serious medical condition (e.g., terminal cancer, renal or liver failure, congestive heart failure)
- Resting blood pressure exceeding 180/100mmHg
- Requires more than a one person assist for transfer
- Planned surgery that would affect participation in the trial
- Participating in another formal lower limbs exercise program more than one day per week
- History of QT prolongation or concomitant use of clearly identified potential QT prolonging drugs, at the investigators discretion (e.g. amiodarone, bepridil, dysopyramide, dofetilide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol, phenothiazines, pimozide, ziprasidone, TCAs, halofantrine, cisapride, and probucol)
- History of glaucoma
- Patients with a history of thrombocytopenia or clinically significant bleeding disorder or use of NSAID, ASA or other anticoagulants, at the investigators' discretion
- History of convulsive disorders
- Potential pregnancy (per screening algorithm)
- Patients with an ongoing history of illicit drug use and/or alcohol abuse
- Patient unwilling or unable to comply with trial requirements
- Patient unable to understand English or communicate with the study team with staff support or translation services
Sites / Locations
- University of Calgary
- University of British Columbia & GF Strong Centre
- Riverview Health Centre
- Memorial University of Newfoundland
- Dalhousie University
- Parkwood Institute
- Sunnybrook Health Sciences Centre
- Toronto Rehabilitation Institute - University Health Network
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fluoxetine Hydrochloride
Placebo
Arm Description
Fluoxetine (Prozac) will be administered to this group. A ramp up period of 3-5 weeks will take place where the patient takes 10mg of Prozac per day. After that, the participant will take the regular dose of 20mg for the duration of the exercise intervention (12 weeks).
An over-encapsulated placebo, or "sugar pill" (so it appears identical to the trial drug) will be administered to this group. During the 3-5 week ramp up period for the experimental group, these participants will take a placebo identical to the 10mg Prozac capsule. After that, the participant will take a placebo identical to the 20mg Prozac capsule for the duration of the exercise intervention (12 weeks).
Outcomes
Primary Outcome Measures
Fugl-Meyer Lower Extremity Score
Fugl-Meyer Lower Extremity Assessment assesses motor and sensorimotor impairment in the lower extremities. Total score is between 0 and 34. Sub-scales include: proximal (0-18), knee/ankle (0-10) and coordination/speed (0-6). Higher scores indicate better performance. Sub-scale scores are summed to calculate total score.
Secondary Outcome Measures
6 Minute Walk Test / 10 Meter Walk Test
Physical Measurement - Ambulatory Function
Knee Strength
Physical Measurement- Lower Limb Strength
Berg Balance Assessment
Physical Measurement - Balance Function
Grip Strength
Physical Measurement - Grip Strength
Waist-to-Hip Ratio
Physical Measurement - Health Measurement
Body Mass Index
Physical Measurement - Health Measurement
Stroke Impact Scale
Stroke-specific, self-report, health status measure. Assesses multiple domains on a 5-point Likert scale. Domains include: strength (4-20), hand function (5-25), activities of daily living/instrumental activities of daily living (10-50), mobility (9-45), communication (7-35), emotion (9-45), memory and thinking (7-35), and participation (8-40). An extra question asks that the patient rate on a scale from 0 - 100 how much they feel that he/she has recovered from his/her stroke. The 4 physical domains (strength, hand function, mobility and activities of daily living) can be summed together to create a single, physical dimension score (28-140) while all other domains should remain separate. Higher scores indicate better function.
Fugl-Meyer Lower Extremity Score
Impairment Measurement (see description above)
Fugl-Meyer Upper Extremity Score
Fugl-Meyer Upper Extremity Assessment assesses motor and sensorimotor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66), and sensation (0-4). Higher scores indicate better performance.
Patient Health Questionnaire (PHQ)-9
Depression Measurement
Simple and Choice Reaction Time Test
Cognitive Measurement
Trail Making Test - A & B
Cognitive Measurement
Montreal Cognitive Assessment (including 5 word recall and clock test)
Cognitive Measurement
Fasting Blood Draws
Biological Biomarker
Full Information
NCT ID
NCT03448159
First Posted
February 21, 2018
Last Updated
November 1, 2022
Sponsor
University Health Network, Toronto
Collaborators
University of British Columbia, Sunnybrook Health Sciences Centre, University of Calgary, Dalhousie University, Parkwood Hospital, London, Ontario, Riverview Health Centre Foundation, Memorial University of Newfoundland, Applied Health Research Centre, Brain Canada, Heart and Stroke Foundation Canadian Partnership for Stroke Recovery
1. Study Identification
Unique Protocol Identification Number
NCT03448159
Brief Title
Fluoxetine Opens Window to Improve Motor Recovery After Stroke
Acronym
FLOW
Official Title
FLOW Trial: Fluoxetine to Open the Critical Period Time Window to Improve Motor Recovery After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
University of British Columbia, Sunnybrook Health Sciences Centre, University of Calgary, Dalhousie University, Parkwood Hospital, London, Ontario, Riverview Health Centre Foundation, Memorial University of Newfoundland, Applied Health Research Centre, Brain Canada, Heart and Stroke Foundation Canadian Partnership for Stroke Recovery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The FLOW trial is a randomized placebo-controlled trial analyzing the effect of coupling an anti-depressant, fluoxetine (Prozac), and exercise to improve motor recovery following a stroke.
Detailed Description
FLOW Trial is a randomized, placebo-controlled, blinded phase II trial evaluating the efficacy of coupling antidepressant therapy (e.g., selective serotonin reuptake inhibitor - fluoxetine) with exercise rehabilitation across multiple Canadian sites in 176 stroke patients. 88 patients will be enrolled in each arm of the study. Both groups will receive an exercise program in addition to standard of care rehabilitation, but only one group (the intervention group) will receive the active drug fluoxetine.
Study participants will be evaluated at baseline, post-exercise program and 6-months post-exercise program. While enrolled in the study, participants will be required to take part in a 12 week, 3 times per week exercise program. Evaluators and patients will be blind to the treatment administered. The trial is constructed with randomization to remove selection and allocation biases and to ensure greater validity in observed differences in the outcome measures. The Applied Health Research Centre (AHRC) in Toronto will act as the coordinating and analysis center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
Keywords
Stroke, Exercise, Fluoxetine, Randomized Control Trial, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Intervention group (will receive the trial drug, fluoxetine, as well as an exercise intervention) Arm 2: Placebo group (will receive a placebo as well as an exercise intervention
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoxetine Hydrochloride
Arm Type
Experimental
Arm Description
Fluoxetine (Prozac) will be administered to this group. A ramp up period of 3-5 weeks will take place where the patient takes 10mg of Prozac per day. After that, the participant will take the regular dose of 20mg for the duration of the exercise intervention (12 weeks).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
An over-encapsulated placebo, or "sugar pill" (so it appears identical to the trial drug) will be administered to this group. During the 3-5 week ramp up period for the experimental group, these participants will take a placebo identical to the 10mg Prozac capsule. After that, the participant will take a placebo identical to the 20mg Prozac capsule for the duration of the exercise intervention (12 weeks).
Intervention Type
Drug
Intervention Name(s)
Fluoxetine Hydrochloride
Other Intervention Name(s)
Prozac
Intervention Description
Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
"Sugar" Pill
Intervention Description
Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.
Primary Outcome Measure Information:
Title
Fugl-Meyer Lower Extremity Score
Description
Fugl-Meyer Lower Extremity Assessment assesses motor and sensorimotor impairment in the lower extremities. Total score is between 0 and 34. Sub-scales include: proximal (0-18), knee/ankle (0-10) and coordination/speed (0-6). Higher scores indicate better performance. Sub-scale scores are summed to calculate total score.
Time Frame
Following completion of the 12-week exercise intervention
Secondary Outcome Measure Information:
Title
6 Minute Walk Test / 10 Meter Walk Test
Description
Physical Measurement - Ambulatory Function
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Knee Strength
Description
Physical Measurement- Lower Limb Strength
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Berg Balance Assessment
Description
Physical Measurement - Balance Function
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Grip Strength
Description
Physical Measurement - Grip Strength
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Waist-to-Hip Ratio
Description
Physical Measurement - Health Measurement
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Body Mass Index
Description
Physical Measurement - Health Measurement
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Stroke Impact Scale
Description
Stroke-specific, self-report, health status measure. Assesses multiple domains on a 5-point Likert scale. Domains include: strength (4-20), hand function (5-25), activities of daily living/instrumental activities of daily living (10-50), mobility (9-45), communication (7-35), emotion (9-45), memory and thinking (7-35), and participation (8-40). An extra question asks that the patient rate on a scale from 0 - 100 how much they feel that he/she has recovered from his/her stroke. The 4 physical domains (strength, hand function, mobility and activities of daily living) can be summed together to create a single, physical dimension score (28-140) while all other domains should remain separate. Higher scores indicate better function.
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Fugl-Meyer Lower Extremity Score
Description
Impairment Measurement (see description above)
Time Frame
6-months post-exercise intervention
Title
Fugl-Meyer Upper Extremity Score
Description
Fugl-Meyer Upper Extremity Assessment assesses motor and sensorimotor impairment in the upper extremities. There is no total score for this measure. Sub-scales include: upper extremity (0-36), wrist (0-10), hand (0-14), coordination/speed (0-6) (which can be combined to form a total motor function score out of 66), and sensation (0-4). Higher scores indicate better performance.
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Patient Health Questionnaire (PHQ)-9
Description
Depression Measurement
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Simple and Choice Reaction Time Test
Description
Cognitive Measurement
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Trail Making Test - A & B
Description
Cognitive Measurement
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Montreal Cognitive Assessment (including 5 word recall and clock test)
Description
Cognitive Measurement
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
Title
Fasting Blood Draws
Description
Biological Biomarker
Time Frame
Following completion of the 12-week exercise intervention and 6-months post-exercise intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
25 years of age or older
Days post stroke must be between 2 to 12 months when enrolled (i.e. day of consent)
Patient-reported hemiparesis of the lower extremity
Exclusion Criteria:
Patients with subarachnoid hemorrhage
Pre-morbid modified Rankin score > 2
Substantial premorbid disability or pre-existing deficit or language comprehension deficit that could interfere with assessments
Diagnosis of major depressive disorder/anxiety disorder requiring antidepressant use within 6 weeks of enrolment
Taking neuroleptic drugs, benzodiazepines, monoamine oxidase inhibitors within 30 days of enrolment
Unstable serious medical condition (e.g., terminal cancer, renal or liver failure, congestive heart failure)
Resting blood pressure exceeding 180/100mmHg
Requires more than a one person assist for transfer
Planned surgery that would affect participation in the trial
Participating in another formal lower limbs exercise program more than one day per week
History of QT prolongation or concomitant use of clearly identified potential QT prolonging drugs, at the investigators discretion (e.g. amiodarone, bepridil, dysopyramide, dofetilide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol, phenothiazines, pimozide, ziprasidone, TCAs, halofantrine, cisapride, and probucol)
History of glaucoma
Patients with a history of thrombocytopenia or clinically significant bleeding disorder or use of NSAID, ASA or other anticoagulants, at the investigators' discretion
History of convulsive disorders
Potential pregnancy (per screening algorithm)
Patients with an ongoing history of illicit drug use and/or alcohol abuse
Patient unwilling or unable to comply with trial requirements
Patient unable to understand English or communicate with the study team with staff support or translation services
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Bayley, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Courtney Pollock, PhD
Organizational Affiliation
University of British Columbia & GF Strong Rehab Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bradley MacIntosh, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Dukelow, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sepideh Pooyania, MD
Organizational Affiliation
Riverview Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Ploughman, PhD
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marilyn Mackay-Lyons, PhD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Teasell, MD
Organizational Affiliation
Parkwood Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of British Columbia & GF Strong Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 1E5
Country
Canada
Facility Name
Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3J5
Country
Canada
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto Rehabilitation Institute - University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2A2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Unused blood samples will be processed and centrally stored in cryovials in a minus 80 degrees freezer for future analyses under the supervision of Study Investigator, Dr. Sandra Black (Sunnybrook, M6 West, 2075 Bayview Avenue, Toronto). The intent is to make the stored frozen cryovials available to all Heart and Stroke Foundation Canadian Partnership of Stroke Recovery (CPSR) investigators to apply for access, but it is currently undecided if other researchers will be allowed to apply for access to the samples. Access will be controlled by a Subcommittee of CPSR Investigators who will review and approve requests and oversee access to the biobank. Stored cryovials will remain at Sunnybrook under the supervision of Dr. Sandra Black for a period of up to 10 years.
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Links:
URL
http://www.heartandstroke.ca/articles/research-breakthrough-to-revolutionize-stroke-treatment
Description
Research breakthrough to revolutionize stroke treatment
URL
http://www.phac-aspc.gc.ca/publicat/2009/cvd-avc/pdf/cvd-avs-2009-eng.pdf
Description
Tracking Heart Disease and Stroke in Canada
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Fluoxetine Opens Window to Improve Motor Recovery After Stroke
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