Clinical trial NCT05369637: Multiple Interventions to Accelerate the Return to the Pre-event Level of Functioning After a TIA and Minor Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transient Ischemic Attack
Minor Stroke
Keywords: Transient Ischemic Attack
Minor Stroke
Non-Pharmacological Interventions
Activities of Daily Living
Randomized Controlled Trial
Lead sponsor: Instituto de Saude Publica da Universidade do Porto
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Time to recovery in each instrumental activity of daily living
timeFrame: 3 months
measure: Recruitment timeframe
timeFrame: 3 months
measure: Adherence to each component of the intervention
timeFrame: 3 months
measure: Dropout
timeFrame: 3 months
Secondary outcomes:
measure: Time of follow-up
timeFrame: 3 months
measure: Complete assessment of participants
timeFrame: 3 months
measure: Implemented sessions
timeFrame: 3 months
measure: Cognitive performance
timeFrame: 3 months
measure: Memory complaints
timeFrame: 3 months
measure: Adherence to the Mediterranean diet
timeFrame: 3 months
measure: Anxiety and depression
timeFrame: 3 months
measure: Reported quality of life
timeFrame: 3 months
measure: Handgrip strength
timeFrame: 3 months
measure: Agility 1
timeFrame: 3 months
measure: Agility 2
timeFrame: 3 months
measure: Upper body strength
timeFrame: 3 months
measure: Lower body strength
timeFrame: 3 months
measure: Upper body flexibility
timeFrame: 3 months
measure: Lower body flexibility
timeFrame: 3 months
measure: Agility 3
timeFrame: 3 months
measure: Aerobic endurance
timeFrame: 3 months
measure: Lower limb function
timeFrame: 3 months
measure: Functional capacity to perform basic activities of daily living
timeFrame: 3 months
measure: Disability
timeFrame: 3 months
measure: 24-hour urinary sodium excretion
timeFrame: 3 months
measure: 24-hour urinary potassium excretion
timeFrame: 3 months
measure: Levels of glycated hemoglobin
timeFrame: 3 months
measure: Body mass index
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto de Saúde Pública da Universidade do Porto
Study officials:
affiliation: Instituto de Saude Publica da Universidade do Porto
name: Vítor Tedim Cruz, PhD
role: PRINCIPAL_INVESTIGATOR
References: