Multiple Interventions to Accelerate the Return to the Pre-event Level of Functioning After a TIA and Minor Stroke

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.

Conditions

• Transient Ischemic Attack
• Minor Stroke

Interventions

BEHAVIORAL

Cognitive training

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).

BEHAVIORAL

Physical exercise

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.

BEHAVIORAL

Behavioral: Nutrition education

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).

BEHAVIORAL

Psychoeducation

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.

OTHER

Diagnosis and correction of hearing impairment

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.

Sponsors & Collaborators

• Instituto de Saude Publica da Universidade do Porto

  lead OTHER

Principal Investigators

• Vítor Tedim Cruz, PhD · Instituto de Saude Publica da Universidade do Porto

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-11

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Portugal

Study Locations