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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
70
This component will comprise the following activities: i. In-person group training (monthly): 60-minute sessions, supervised by a psychologist; ii. Home individual training (≥5 times per week): unsupervised 30-minutes remote sessions, using the COGWEB® online platform or paper/pencil exercises (for those participants without computer/internet or who do not use one autonomously).
This component will be based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher: i. In-person group training (monthly); ii. In-person group training or remote synchronous training or provision of education booklets with photos and exercise instructions to be performed individually (twice weekly), depending on the evolution of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic.
This component will be based on the following activities: i. In-person group 120-minute sessions (monthly), guided by a nutritionist, comprising: presentation and discussion of healthy and easy to cook recipes by the nutritionist and preparation of healthy meals by the participants; ii. In-person individual appointment with a nutritionist (monthly).
This component will be based on in-person group sessions (monthly; 60-minute) supervised by a psychologist, aiming to promote the acquisition of important knowledge about secondary prevention and support people understanding, exploring, and self-managing their emotions and impairments.
This component will be based on a evaluation session conducted by otolaryngologists and audiologists, who will evaluate previous hearing problems and use of hearing aids, and include an otoscopy and an audiogram.
Instituto de Saúde Pública da Universidade do Porto
Porto, Portugal
RECRUITINGTime to recovery in each instrumental activity of daily living
Time to recovery in each instrumental activity of daily living measured by an adapted version of the Frenchay Activities Index.
Time frame: 3 months
Recruitment timeframe
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.
Time frame: 3 months
Adherence to each component of the intervention
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.
Time frame: 3 months
Dropout
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 frame: 3 months
Time of follow-up
Number of days between the first and the last session attended by the participant.
Time frame: 3 months
Complete assessment of participants
For each study outcome, proportion of participants with complete information, calculated at baseline and follow-up, as the number of participants with complete information divided by the total number of participants evaluated.
Time frame: 3 months
Implemented sessions
Proportion of sessions implemented, calculated as the number of sessions that the research team was able to implement divided by the total number of sessions planned.
Time frame: 3 months
Cognitive performance
Variation of participant's cognitive performance assessed using the Montreal Cognitive Assessment, between the baseline and the follow-up assessments. This scale varies from 0 (worst cognitive performance) to 30 points (best cognitive performance).
Time frame: 3 months
Memory complaints
Variation of the self-reported memory complaints, assessed using the Subjective Memory Complaints Scale, between the baseline and follow-up assessments. This scale varies from 0 (best score) to 21 points (worst score). Scores over three points indicate the presence of self-reported memory complaints.
Time frame: 3 months
Adherence to the Mediterranean diet
Variation of participant's self-reported adherence to the Mediterranean diet, assessed using the Mediterranean food pattern (MEDAS) scale, between the baseline and the follow-up assessments. This scale varies from 0 (lowest adherence to the Mediterranean diet) to 14 points (highest adherence to the Mediterranean diet). A score over 10 points indicates good adherence to the Mediterranean diet.
Time frame: 3 months
Anxiety and depression
Variation of the anxiety and depression scores, assessed using the Hospital Anxiety and Depression Scale (HADS), between the baseline and the follow-up assessments. This scale varies from 0 (best score) to 21 points (worst score).
Time frame: 3 months
Reported quality of life
Variation of participant's quality of life, assessed using the EuroQol Group scale - 5 dimensions (EQ-5D) scale, between the baseline and the follow-up assessments. This scale is subdivided in two subscales: a) five multiple choice questions, with five response possibilities, which produce a score that varies from 5 (best score) to 25 points (worst score); b) visual analogic scale, that varies from 0 (worst score) to 100 (best score).
Time frame: 3 months
Handgrip strength
Variation of participant's handgrip strength, assessed using a dynamometer, between the baseline and the follow-up assessments.
Time frame: 3 months
Agility 1
Variation of participant's agility and balance, assessed using the Timed Up and Go Test scale, between the baseline and the follow-up assessments. This is measured in time units (seconds) and varies from 0 (best score) to infinite (worst score).
Time frame: 3 months
Agility 2
Variation of participant's agility and balance, assessed using the Unipedal Stance Test, between the baseline and the follow-up assessments. This is measured in time units (seconds) and varies from 0 (best score) to infinite (worst score).
Time frame: 3 months
Upper body strength
Variation of participant's upper body strength assessed using the 30-second arm curl test, from the Senior Fitness Test.
Time frame: 3 months
Lower body strength
Variation of participant's lower body strength assessed using the 30-second chair stand test, from the Senior Fitness Test.
Time frame: 3 months
Upper body flexibility
Variation of participant's upper body flexibility assessed using the back-scratch test, from the Senior Fitness Test.
Time frame: 3 months
Lower body flexibility
Variation of participant's lower body flexibility assessed using the chair sit-and-reach test, from the Senior Fitness Test.
Time frame: 3 months
Agility 3
Variation of participant's agility and dynamic balance assessed using the 8-foot distance test (2,44 meters), from the Senior Fitness Test.
Time frame: 3 months
Aerobic endurance
Variation of participant's aerobic endurance assessed using the 2-minute step test, from the Senior Fitness Test.
Time frame: 3 months
Lower limb function
Variation of participant's lower limb function, assessed using the Short Physical Performance Battery (SPPB), which tests 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Time frame: 3 months
Functional capacity to perform basic activities of daily living
Variation of participant's independence on performing basic activities of daily living, using the Barthel Index, which ranges from 0 to 20 and higher scores represent increased functionality and independence.
Time frame: 3 months
Disability
Variation of participant's disability assessed via modified Rankin Scale, with scores ranging from 0 (perfect health) to 6 (dead).
Time frame: 3 months
24-hour urinary sodium excretion
Variation of participant's urinary sodium excretion, between the baseline and the follow-up assessments. This parameter will be measured through a laboratory analysis of participants' 24-hour urinary samples and will be analyzed as a proxy of dietary salt intake.
Time frame: 3 months
24-hour urinary potassium excretion
Variation of participant's urinary potassium excretion, between the baseline and the follow-up assessments. This parameter will be measured through a laboratory analysis of participants' 24-hour urinary samples and will be analyzed as a proxy of dietary potassium intake.
Time frame: 3 months
Levels of glycated hemoglobin
Variation of participant's levels of glycated hemoglobin, between the baseline and the follow-up assessments. This parameter will be measured through a laboratory analysis of participants' blood sample and will be used to analyze glycemic control.
Time frame: 3 months
Body mass index
Variation of participant's body mass index between the baseline and the follow-up assessments.
Time frame: 3 months
Blood pressure
Variation of participant's systolic and diastolic blood pressure between the baseline and the follow-up assessments.
Time frame: 3 months
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