FLOW Trial: Fluoxetine to Open the Critical Period Time Window to Improve Motor Recovery After Stroke
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 8
- 主要终点
- Fugl-Meyer Lower Extremity Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Fluoxetine Hydrochloride
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).
干预措施: Fluoxetine Hydrochloride (Drug)
Fluoxetine Hydrochloride
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).
干预措施: Exercise Program (Behavioral)
Placebo
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).
干预措施: Placebo (Other)
Placebo
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).
干预措施: Exercise Program (Behavioral)
结局指标
主要结局
Fugl-Meyer Lower Extremity Score
时间窗: Following completion of the 12-week exercise intervention
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.
次要结局
- Trail Making Test - A & B(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Grip Strength(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Waist-to-Hip Ratio(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Fugl-Meyer Upper Extremity Score(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Simple and Choice Reaction Time Test(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Berg Balance Assessment(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Stroke Impact Scale(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Patient Health Questionnaire (PHQ)-9(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- 6 Minute Walk Test / 10 Meter Walk Test(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Knee Strength(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Body Mass Index(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Fugl-Meyer Lower Extremity Score(6-months post-exercise intervention)
- Montreal Cognitive Assessment (including 5 word recall and clock test)(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)
- Fasting Blood Draws(Following completion of the 12-week exercise intervention and 6-months post-exercise intervention)