Back to Normal - Multiple Non-pharmacological Interventions to Accelerate the Return to the Pre-event Level of Functioning After a Transient Ischemic Attack and Minor Stroke - a Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transient Ischemic Attack
- Sponsor
- Instituto de Saude Publica da Universidade do Porto
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Recruitment timeframe
- Last Updated
- 3 years ago
Overview
Brief Summary
The occurrence of a transient ischemic attack (TIA) or a minor stroke is frequently assumed as a temporary and non-disabling event. Nevertheless, patients can experience subtle but meaningful impairments, including a decreased performance in activities of daily living (ADLs), a high prevalence of depression, cognitive decline, physical deficits, hearing degeneration, with implications in returning to work, social relations and activities. Additionally, it has been described a higher risk of stroke among these patients, which highlights the importance of promoting secondary prevention, soon after these acute episodes. Therefore, this pilot randomized controlled trial (RCT) aims to evaluate the feasibility and the effectiveness of a three-month multidomain intervention program, composed of five non-pharmacological components which may contribute to accelerate the return to the pre-event level of functioning in patients with TIA and minor stroke. The results may guide future clinical practices and health policies aiming to reduce the overall burden of stroke.
Detailed Description
This is pragmatic non-pharmacological RCT, which will include patients diagnosed with a TIA or a minor stroke recruited at the emergency or neurology departments of the Hospital Pedro Hispano, located in Matosinhos, Portugal (n=70). Those who accept to participate will be randomly allocated to 2 groups (1:1): (a) Intervention - will receive a combined approach of cognitive training, physical exercise, nutrition education and psychoeducation sessions, during three-months, as well as assessment/correction of hearing loss; (b) Control - participants will not be subject to any intervention. Both groups will receive the usual standard of care provided to these types of clinical diseases. Data will be collected using different strategies. Trained interviewers will conduct face-to-face interviews, covering sociodemographic characteristics, lifestyles (including adherence to the mediterranean diet), health status, and will perform anthropometry and measure blood pressure as well as physical performance. The complete or partial recovery time of instrumental ADLs will be assessed using an adapted version of the Frenchay Activities Index. Disability and basic ADLs will be also evaluated (Modified Rankin Scale and Barthel Index, respectively). Cognitive function will be evaluated using the Montreal Cognitive Assessment and a self-administered web-based tool for remote longitudinal assessment (Brain on Track), if applicable. Symptoms of anxiety and depression, as well as quality of life, will be evaluated through self-administered instruments. Levels of glycated hemoglobin and 24-hour urinary sodium, potassium and creatinine excretions, as well as pH levels, will be also measured. All participants will be evaluated at 0 and 3 months after the beginning of the intervention. Electronic medical records will be assessed to obtain clinical data. Functionality recovery will be defined as a primary outcome and additional information regarding the feasibility, outcomes and sample size requirements of such programs will also be assessed, which is crucial to implement a large-scale RCT. This project was previously approved by the Local Ethics Committee and by the Data Protection Officer of the Institute of Public Health of the University of Porto. In this context, all procedures will be undertaken to guarantee compliance with ethical standards, as well as data protection and safety, considering national and international laws. This study will be developed as part of the project "Multiple Interventions to Prevent Cognitive Decline" (MIND-Matosinhos).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18-85 years old;
- •Clinical diagnosis of transient ischemic stroke or minor stroke as defined by the National Institute of Health Stroke Scale score ≤3;
- •Onset of symptoms within the last seven days;
- •First-time stroke or TIA;
- •Four or more years of education;
- •Discharged home without the need for inpatient rehabilitation;
- •Modified Rankin Scale 0 to 2, inclusive.
Exclusion Criteria
- •Unable to attend the face-to-face intervention sessions;
- •Previous diagnosis of Dementia or severe disability;
- •Contraindication for physical exercise;
- •Severe loss of hearing, vision, or communication skills;
- •Frailty, reduced life expectancy due to severe disease or need for regular treatments that compete with availability for intervention.
Outcomes
Primary Outcomes
Recruitment timeframe
Time Frame: 3 months
Proportion of participants recruited within the seven days post-onset of symptoms will be calculated as the number of participants recruited within the time frame divided by the total number of participants.
Dropout
Time Frame: 3 months
Proportion of participants who dropped out of the study, calculated as the number of participants who dropped out after attending at least one session divided by the total number of participants who attended at least one session.
Time to recovery in each instrumental activity of daily living
Time Frame: 3 months
Time to recovery in each instrumental activity of daily living measured by an adapted version of the Frenchay Activities Index.
Adherence to each component of the intervention
Time Frame: 3 months
Proportion of adherence to each component of the intervention and to different intervention modalities (remote/in person), calculated as the number of sessions attended divided by the total number of sessions implemented. For remote cognitive training the outcome will be the absolute number of sessions.
Secondary Outcomes
- Adherence to the Mediterranean diet(3 months)
- Aerobic endurance(3 months)
- Complete assessment of participants(3 months)
- Cognitive performance(3 months)
- Anxiety and depression(3 months)
- Agility 2(3 months)
- Lower body strength(3 months)
- Reported quality of life(3 months)
- Handgrip strength(3 months)
- Upper body flexibility(3 months)
- 24-hour urinary potassium excretion(3 months)
- Levels of glycated hemoglobin(3 months)
- Body mass index(3 months)
- Blood pressure(3 months)
- Time of follow-up(3 months)
- Implemented sessions(3 months)
- Memory complaints(3 months)
- Agility 1(3 months)
- Disability(3 months)
- Upper body strength(3 months)
- Lower body flexibility(3 months)
- Agility 3(3 months)
- Functional capacity to perform basic activities of daily living(3 months)
- Lower limb function(3 months)
- 24-hour urinary sodium excretion(3 months)