Multiple Interventions to Accelerate the Return to the Pre-event Level of Functioning After a TIA and Minor Stroke
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
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedStudy Start
First participant enrolled
May 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 3, 2022
May 1, 2022
7 months
May 2, 2022
May 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
3 months
Secondary Outcomes (25)
Time of follow-up
3 months
Complete assessment of participants
3 months
Implemented sessions
3 months
Cognitive performance
3 months
Memory complaints
3 months
- +20 more secondary outcomes
Study Arms (2)
Non-pharmacological Intervention
EXPERIMENTALParticipants 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 INTERVENTIONControl group will receive the usual standard of care provided to these clinical diseases.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Saúde Pública da Universidade do Porto
Porto, 4050-600, Portugal
Related Publications (1)
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.
PMID: 37117001DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vítor Tedim Cruz, PhD
Instituto de Saude Publica da Universidade do Porto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2022
First Posted
May 11, 2022
Study Start
May 11, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
June 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share