Transient Ischemic AttackNCT05369637
Multiple Interventions to Accelerate the Return to the Pre-event Level of Functioning After a TIA and Minor Stroke
A study testing Cognitive training, Physical exercise and Behavioral: Nutrition education in people with Transient Ischemic Attack and Minor Stroke, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Transient Ischemic Attack, Minor Stroke
- What is being tested?
- Cognitive training, Physical exercise and Behavioral: Nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePortugal
- Study dates
- 11 May 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Instituto de Saúde Pública da Universidade do Porto
Porto, 4050-600
Ana Rute Costa, +351 22 206 1820
About this study
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
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.
Read the 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).
- Conditions
- Transient Ischemic Attack, Minor Stroke
- Being tested
- Cognitive training, Physical exercise, Behavioral: Nutrition education, Psychoeducation, Diagnosis and correction of hearing impairment
- Keywords
- Transient Ischemic Attack, Minor Stroke, Non-Pharmacological Interventions, Activities of Daily Living, Randomized Controlled Trial
- Medical subject headings
- Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingBehavioural
This component will comprise the following activities:
- 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 exerciseBehavioural
This component will be based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, supervised by a physical education teacher:
- 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 educationBehavioural
This component will be based on the following activities:
- 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).
PsychoeducationBehavioural
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 impairmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmacological Intervention | Experimental | 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. Receives: Behavioral: Cognitive training; Behavioral: Physical exercise; Behavioral: Behavioral: Nutrition education; Behavioral: Psychoeducation; Other: Diagnosis and correction of hearing impairment |
| Control group | No intervention | Control group will receive the usual standard of care provided to these clinical diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (25)
Time of follow-up
Number of days between the first and the last session attended by the participant.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 3 months
Handgrip strength
Variation of participant's handgrip strength, assessed using a dynamometer, between the baseline and the follow-up assessments.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 months
Upper body flexibility
Variation of participant's upper body flexibility assessed using the back-scratch test, from the Senior Fitness Test.
Measured: 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.
Measured: 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.
Measured: 3 months
Aerobic endurance
Variation of participant's aerobic endurance assessed using the 2-minute step test, from the Senior Fitness Test.
Measured: 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).
Measured: 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.
Measured: 3 months
Disability
Variation of participant's disability assessed via modified Rankin Scale, with scores ranging from 0 (perfect health) to 6 (dead).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Body mass index
Variation of participant's body mass index between the baseline and the follow-up assessments.
Measured: 3 months
Blood pressure
Variation of participant's systolic and diastolic blood pressure between the baseline and the follow-up assessments.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start11 May 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Saude Publica da Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vítor Tedim Cruz, PhD, Principal investigator, Instituto de Saude Publica da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369637
- Sponsor's protocol ID
- 75/CES/JAS/2021
- Status last verified
- May 2022
- First submitted
- 2 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goncalves M, Lima MJ, Fonseca A, Duque C, Costa AR, Cruz VT. Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial. BMJ Open. 2023 Apr 28;13(4):e069593. doi: 10.1136/bmjopen-2022-069593.
PubMed 37117001
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05369637
- Acronym / sponsor ID
- 75/CES/JAS/2021
- Conditions
- Transient Ischemic Attack, Minor Stroke
- Keywords
- Transient Ischemic Attack, Minor Stroke, Non-Pharmacological Interventions, Activities of Daily Living, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Instituto de Saude Publica da Universidade do PortoUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacological Intervention | Experimental | Behavioral: Cognitive training, Behavioral: Physical exercise, Behavioral: Behavioral: Nutrition education, Behavioral: Psychoeducation, Other: Diagnosis and correction of hearing impairmentParticipants 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. |
| Control group | No intervention | –Control group will receive the usual standard of care provided to these clinical diseases. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingThis 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). | Behavioural | Non-pharmacological Intervention |
| Physical exerciseThis 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. | Behavioural | Non-pharmacological Intervention |
| Behavioral: Nutrition educationThis 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). | Behavioural | Non-pharmacological Intervention |
| PsychoeducationThis 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. | Behavioural | Non-pharmacological Intervention |
| Diagnosis and correction of hearing impairmentThis 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. | Other | Non-pharmacological Intervention |
Primary outcome
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.
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.
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.
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.
25 secondary outcomes
Time of follow-up
Time frame: 3 months
Complete assessment of participants
Time frame: 3 months
Implemented sessions
Time frame: 3 months
Cognitive performance
Time frame: 3 months
Memory complaints
Time frame: 3 months
Adherence to the Mediterranean diet
Time frame: 3 months
Anxiety and depression
Time frame: 3 months
Reported quality of life
Time frame: 3 months
Handgrip strength
Time frame: 3 months
Agility 1
Time frame: 3 months
Agility 2
Time frame: 3 months
Upper body strength
Time frame: 3 months
Lower body strength
Time frame: 3 months
Upper body flexibility
Time frame: 3 months
Lower body flexibility
Time frame: 3 months
Agility 3
Time frame: 3 months
Aerobic endurance
Time frame: 3 months
Lower limb function
Time frame: 3 months
Functional capacity to perform basic activities of daily living
Time frame: 3 months
Disability
Time frame: 3 months
24-hour urinary sodium excretion
Time frame: 3 months
24-hour urinary potassium excretion
Time frame: 3 months
Levels of glycated hemoglobin
Time frame: 3 months
Body mass index
Time frame: 3 months
Blood pressure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Derived from this study: PubMed 37117001Goncalves M, Lima MJ, Fonseca A, Duque C, Costa AR, Cruz VT. Study protocol for a pilot randomised controlled trial evaluating the feasibility and effectiveness of non-pharmacological interventions to recover functionality after a transient ischaemic attack or a minor stroke: the 'Back to Normal' trial. BMJ Open. 2023 Apr 28;13(4):e069593. doi: 10.1136/bmjopen-2022-069593.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vítor Tedim Cruz, PhD principal investigator
Instituto de Saude Publica da Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training, Physical exercise and Behavioral: Nutrition education in people with Transient Ischemic Attack and Minor Stroke, run by Instituto de Saude Publica da Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Rute Costa, PhD (+351 22 206 1820, arcosta@ispup.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery in each instrumental activity of daily living (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.