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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Transient Ischemic Attack Minor Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non-pharmacological Intervention

Participants in the intervention group will receive a multidomain non-pharmacological program, including cognitive training, physical exercise, nutrition education, psychoeducation, and diagnosis and correction of hearing impairment.

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

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).

Physical exercise

Intervention Type BEHAVIORAL

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: Nutrition education

Intervention Type BEHAVIORAL

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).

Psychoeducation

Intervention Type BEHAVIORAL

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.

Diagnosis and correction of hearing impairment

Intervention Type OTHER

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.

Control group

Control group will receive the usual standard of care provided to these clinical diseases.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type 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.

Intervention Type 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).

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No