StrokeNCT06068036
Telehealth Intervention Involving HEARTS Technical Package and Activity Monitor to Promote Physical Activity Post-stroke
A study testing Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®) and Telehealth intervention: HEARTS technical package in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®) and Telehealth intervention: HEARTS technical package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Sep 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke for more than six months;
- ≥18 years of age;
- Be rated as "Inactive" according to Human Activity Profile (HAP);
- Provide medical approval to practice physical activity.
Who cannot join
- Positive screening test for possible cognitive alterations;
- Pain or other adverse health condition that compromises the performance of the proposed intervention program, such as vestibular disorders, severe arthritis or any other diagnosis of disease of the nervous system.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
Christina Faria, PhD, +55 (31) 34097448, cdcmf@ufmg.br
About this study
Official title: Telehealth Intervention Involving the HEARTS Technical Package and the Use of an Activity Monitor to Increase Physical Activity Level Post-stroke: a Feasibility Randomized Controlled Trial
Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the parameters for conducting a fully powered RCT.
Design: A Phase 1 feasibility RCT study with blinded assessment will assign eligible participants to experimental or control group. Participants in both groups will undergo a theoretically informed telehealth intervention based on the HEARTS technical package (a face-to-face session and telephone call follow-up). The experimental group will have additional use of the Mi Band 7® Smartwatch activity monitor. For both groups, the intervention will last for 12 weeks. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting.
Read more
Study Outcomes: Feasibility of recruitment, intervention, and measurement, and clinical outcomes.
Conclusions: Results from this feasibility RCT study will inform on the design and sample required for a fully powered RCT with a similar aim.
Read the detailed description
Standard Operating Procedures: A non-probabilistic sample will be recruited from the community. Recruitment strategies include: referrals (e.g, phone numbers obtained from other research projects and university extension programs) and advertisements (e.g. physical folders distributed in public places, and electronic pamphlets published on social media). All subjects will be informed about the study procedures and will provide written consent. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting. Two independent examiners, blinded to the group allocation, will enter the data into a statistical software package, verify any missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. Analysis will be carried-out by a researcher, blinded to the group allocation. All individuals will receive an identification code to ensure anonymity.
Statistical analyzes: All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be calculated for all outcomes. The effect sizes will be calculated to determine the magnitude of within-groups and between-groups comparisons. The level of significance will be set at 5% and adjusted for multiple comparisons.
- Conditions
- Stroke
- Being tested
- Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®), Telehealth intervention: HEARTS technical package
- Keywords
- Stroke, Physical activity, Telehealth, Feasibility Study, Randomized controlled trial
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®)Behavioural
Telehealth intervention involving the HEARTS technical package and the use of Smartwatch Mi Band 7® activity monitor. The HEARTS technical package presents the 5As brief intervention (Ask, Advise, Assess, Assist, Arrange) to promote physical activity participation. Participants will receive a physical activity monitor (as instructed in the HEARTS technical package) and will be monitored by telephone call, once a week, in order to reinforce successes and identify solutions to difficulties (as instructed in the HEARTS technical package) to practice physical activity. These individuals will undertake a 12-week intervention program. In the first week, individuals will perform the first four steps of the 5As brief intervention in person, where they will be instructed on how to use the physical activity monitor, they will receive a diary of regular physical activity practice, will be guided on how to fill it out, and will schedule the best times to receive the weekly telephone call.
Telehealth intervention: HEARTS technical packageBehavioural
The same intervention as the experimental group, but without the additional use of the physical activity monitor (Smartwatch Mi Band 7®).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Telehealth intervention involving the HEARTS technical package and the use of Smartwatch Mi Band 7® activity monitor. The HEARTS technical package presents the 5As brief intervention (Ask, Advise, Assess, Assist, Arrange) to promote physical activity participation. Participants will receive a physical activity monitor (as instructed in the HEARTS technical package) and will be monitored by telephone call, once a week, in order to reinforce successes and identify solutions to difficulties (as instructed in the HEARTS technical package) to practice physical activity. These individuals will undertake a 12-week intervention program. In the first week, individuals will perform the first four steps of the 5As brief intervention in person, where they will be instructed on how to use the physical activity monitor, they will receive a diary of regular physical activity practice, will be guided on how to fill it out, and will schedule the best times to receive the weekly telephone call. Receives: Behavioral: Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®) |
| Control group | Active comparator | Participants will undergo the same intervention as the experimental group, but will not receive the physical activity monitor (Smartwatch Mi Band 7®). Receives: Behavioral: Telehealth intervention: HEARTS technical package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).
Measured: At enrolment and allocation.
Feasibility of intervention (retention)
It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.
Measured: At allocation and post-intervention (week-12).
Feasibility of intervention (follow-up of individuals)
It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated.
Measured: At allocation, post-intervention (week-12), and one month after the end of the intervention (week-16).
Feasibility of intervention (attendance)
It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.
Measured: At allocation and post-intervention (week-12).
Feasibility of intervention (safety)
It will be determined by the number and reasons of adverse events (e.g. pain, falls, hospitalization, and death) identified during the period of intervention and follow-up of the individual.
Measured: During the intervention (12 weeks) and follow-up (4 weeks).
Feasibility of intervention (perceived effectiveness)
It will be determined by the following question: "Comparing how it was before you carried out the intervention and now, do you think that your ability to perform routine physical activity is: much worse, moderately worse, a little worse, the same, a little better, moderately better, or very better?".
Measured: At post-intervention (week-12).
Feasibility of measurement
It will be determined by the percentage of clinical outcomes measured (ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured), and the percentage of participants who filled-out the diary (ratio between the number of individuals who filled-out the diary and the number of individuals who started the proposed intervention program).
Measured: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Secondary outcomes (6)
Physical activity level
Human Activity Profile (HAP). One of the outcomes provided by the instrument is the Maximum Activity Score (MAS). From the MAS, the Adjusted Activity Score (AAS) can be found by subtracting from the MAS the number of activities that the individual provided as the answer "I stopped doing". Higher scores indicate better outcome.
Measured: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Number of post-stroke individuals who became physically active
Human Activity Profile (HAP). One of the measures provided by the questionnaire is the "Activity Rating", which provides an overall rating of the respondent's activity level into "Inactive", "Moderately active" and "Active".
Measured: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Systolic and diastolic blood pressure
Tycos® aneroid sphygmomanometer (WelchAllyn Inc., NY, USA, Model DS44) and stethoscope (Litmann Classic II SE 3M®, USA).
Measured: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Lifestyle-related energy consumption
Human Activity Profile (HAP). One of the measures provided by the questionnaire is the "Lifestyle-related energy consumption", which provides a measure of actual oxygen consumption estimated from the "Activity Adjusted Score" (AAS). This measure is operationalized in ml.kg-1.min-1. Higher scores indicate better outcome.
Measured: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Self-efficacy for physical activity
Self-efficacy for Physical Activity Scale. The scale has 10 items and has two response options: "Yes" is computed as 1 and "No" is computed as 0. The total score is defined by the sum of the scores for each item. The minimum total score is 0 and the maximum total score is 10. The higher the total score, the higher the self-efficacy for physical activity.
Measured: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Health-related quality of life
Stroke Specific Quality of Life Scale (SS-QOL). The scale has 49 items across 12 domains (items are rated on a 5-point Likert scale) and has three different sets of responses (indicated on the scale). The total score is defined by the sum of the scores for each item. The minimum total score is 49 and the maximum total score is 245. The higher the total score, the better the health-related quality of life.
Measured: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start27 Sep 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Worldwide Universities Network
- Responsible party
- Principal investigator, Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
- Investigators
- Christina Faria, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068036
- Sponsor's protocol ID
- CAAE: 66980723.2.0000.5149
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gladstone DJ, Lindsay MP, Douketis J, Smith EE, Dowlatshahi D, Wein T, Bourgoin A, Cox J, Falconer JB, Graham BR, Labrie M, McDonald L, Mandzia J, Ngui D, Pageau P, Rodgerson A, Semchuk W, Tebbutt T, Tuchak C, van Gaal S, Villaluna K, Foley N, Coutts S, Mountain A, Gubitz G, Udell JA, McGuff R, Heran MKS, Lavoie P, Poppe AY; Canadian Stroke Consortium. Canadian Stroke Best Practice Recommendations: Secondary Prevention of Stroke Update 2020. Can J Neurol Sci. 2022 May;49(3):315-337. doi: 10.1017/cjn.2021.127. Epub 2021 Jun 18.
PubMed 34140063Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117Lynch EA, Jones TM, Simpson DB, Fini NA, Kuys SS, Borschmann K, Kramer S, Johnson L, Callisaya ML, Mahendran N, Janssen H, English C; ACTIOnS Collaboration. Activity monitors for increasing physical activity in adult stroke survivors. Cochrane Database Syst Rev. 2018 Jul 27;7(7):CD012543. doi: 10.1002/14651858.CD012543.pub2.
PubMed 30051462Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
PubMed 26978655Peniche PDC, Lennon O, Magalhaes JP, Dos Santos JM, Polese JC, Faria CDCM. Telehealth intervention involving the HEARTS Technical Package and the additional use of an activity monitor to increase physical activity level post-stroke: Protocol for a feasibility randomized controlled trial. PLoS One. 2025 Apr 4;20(4):e0320026. doi: 10.1371/journal.pone.0320026. eCollection 2025.
PubMed 40184417
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Intervention Involving the HEARTS Technical Package and the Use of an Activity Monitor to Increase Physical Activity Level Post-stroke: a Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06068036
- Acronym / sponsor ID
- CAAE: 66980723.2.0000.5149
- Conditions
- Stroke
- Keywords
- Stroke, Physical activity, Telehealth, Feasibility Study, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Worldwide Universities Network
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 Oct 2023 (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.
Objectives: The aim of this feasibility randomized controlled trial (RCT) study is to investigate whether the theoretically informed telehealth intervention involving the HEARTS Technical Package and the use of an activity monitor to increase physical activity level post-stroke is feasible and to estimate the parameters for conducting a fully powered RCT.
Design: A Phase 1 feasibility RCT study with blinded assessment will assign eligible participants to experimental or control group. Participants in both groups will undergo a theoretically informed telehealth intervention based on the HEARTS technical package (a face-to-face session and telephone call follow-up). The experimental group will have additional use of the Mi Band 7® Smartwatch activity monitor. For both groups, the intervention will last for 12 weeks. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting.
Study Outcomes: Feasibility of recruitment, intervention, and measurement, and clinical outcomes.
Conclusions: Results from this feasibility RCT study will inform on the design and sample required for a fully powered RCT with a similar aim.
Detailed description
Standard Operating Procedures: A non-probabilistic sample will be recruited from the community. Recruitment strategies include: referrals (e.g, phone numbers obtained from other research projects and university extension programs) and advertisements (e.g. physical folders distributed in public places, and electronic pamphlets published on social media). All subjects will be informed about the study procedures and will provide written consent. The feasibility outcomes will be identified considering the different phases of conducting the study. A trained researcher, blinded to the group allocation, will collect the sociodemographic, anthropometric, and clinical outcomes, in a university laboratory setting. Two independent examiners, blinded to the group allocation, will enter the data into a statistical software package, verify any missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. Analysis will be carried-out by a researcher, blinded to the group allocation. All individuals will receive an identification code to ensure anonymity.
Statistical analyzes: All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be calculated for all outcomes. The effect sizes will be calculated to determine the magnitude of within-groups and between-groups comparisons. The level of significance will be set at 5% and adjusted for multiple comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®)Telehealth intervention involving the HEARTS technical package and the use of Smartwatch Mi Band 7® activity monitor. The HEARTS technical package presents the 5As brief intervention (Ask, Advise, Assess, Assist, Arrange) to promote physical activity participation. Participants will receive a physical activity monitor (as instructed in the HEARTS technical package) and will be monitored by telephone call, once a week, in order to reinforce successes and identify solutions to difficulties (as instructed in the HEARTS technical package) to practice physical activity. These individuals will undertake a 12-week intervention program. In the first week, individuals will perform the first four steps of the 5As brief intervention in person, where they will be instructed on how to use the physical activity monitor, they will receive a diary of regular physical activity practice, will be guided on how to fill it out, and will schedule the best times to receive the weekly telephone call. |
| Control group | Active comparator | Behavioral: Telehealth intervention: HEARTS technical packageParticipants will undergo the same intervention as the experimental group, but will not receive the physical activity monitor (Smartwatch Mi Band 7®). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of stroke for more than six months;
- ≥18 years of age;
- Be rated as "Inactive" according to Human Activity Profile (HAP);
- Provide medical approval to practice physical activity.
Key exclusion criteria (2 listed)
- Positive screening test for possible cognitive alterations;
- Pain or other adverse health condition that compromises the performance of the proposed intervention program, such as vestibular disorders, severe arthritis or any other diagnosis of disease of the nervous system.
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 |
|---|---|---|
| Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®)Telehealth intervention involving the HEARTS technical package and the use of Smartwatch Mi Band 7® activity monitor. The HEARTS technical package presents the 5As brief intervention (Ask, Advise, Assess, Assist, Arrange) to promote physical activity participation. Participants will receive a physical activity monitor (as instructed in the HEARTS technical package) and will be monitored by telephone call, once a week, in order to reinforce successes and identify solutions to difficulties (as instructed in the HEARTS technical package) to practice physical activity. These individuals will undertake a 12-week intervention program. In the first week, individuals will perform the first four steps of the 5As brief intervention in person, where they will be instructed on how to use the physical activity monitor, they will receive a diary of regular physical activity practice, will be guided on how to fill it out, and will schedule the best times to receive the weekly telephone call. | Behavioural | Experimental group |
| Telehealth intervention: HEARTS technical packageThe same intervention as the experimental group, but without the additional use of the physical activity monitor (Smartwatch Mi Band 7®). | Behavioural | Control group |
Primary outcome
Feasibility of recruitment
Time frame: At enrolment and allocation.
It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).
Feasibility of intervention (retention)
Time frame: At allocation and post-intervention (week-12).
It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.
Feasibility of intervention (follow-up of individuals)
Time frame: At allocation, post-intervention (week-12), and one month after the end of the intervention (week-16).
It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated.
Feasibility of intervention (attendance)
Time frame: At allocation and post-intervention (week-12).
It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.
Feasibility of intervention (safety)
Time frame: During the intervention (12 weeks) and follow-up (4 weeks).
It will be determined by the number and reasons of adverse events (e.g. pain, falls, hospitalization, and death) identified during the period of intervention and follow-up of the individual.
Feasibility of intervention (perceived effectiveness)
Time frame: At post-intervention (week-12).
It will be determined by the following question: "Comparing how it was before you carried out the intervention and now, do you think that your ability to perform routine physical activity is: much worse, moderately worse, a little worse, the same, a little better, moderately better, or very better?".
Feasibility of measurement
Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
It will be determined by the percentage of clinical outcomes measured (ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured), and the percentage of participants who filled-out the diary (ratio between the number of individuals who filled-out the diary and the number of individuals who started the proposed intervention program).
6 secondary outcomes
Physical activity level
Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Number of post-stroke individuals who became physically active
Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Systolic and diastolic blood pressure
Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Lifestyle-related energy consumption
Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Self-efficacy for physical activity
Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Health-related quality of life
Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 34140063Gladstone DJ, Lindsay MP, Douketis J, Smith EE, Dowlatshahi D, Wein T, Bourgoin A, Cox J, Falconer JB, Graham BR, Labrie M, McDonald L, Mandzia J, Ngui D, Pageau P, Rodgerson A, Semchuk W, Tebbutt T, Tuchak C, van Gaal S, Villaluna K, Foley N, Coutts S, Mountain A, Gubitz G, Udell JA, McGuff R, Heran MKS, Lavoie P, Poppe AY; Canadian Stroke Consortium. Canadian Stroke Best Practice Recommendations: Secondary Prevention of Stroke Update 2020. Can J Neurol Sci. 2022 May;49(3):315-337. doi: 10.1017/cjn.2021.127. Epub 2021 Jun 18.
- Background: PubMed 34024117Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Background: PubMed 30051462Lynch EA, Jones TM, Simpson DB, Fini NA, Kuys SS, Borschmann K, Kramer S, Johnson L, Callisaya ML, Mahendran N, Janssen H, English C; ACTIOnS Collaboration. Activity monitors for increasing physical activity in adult stroke survivors. Cochrane Database Syst Rev. 2018 Jul 27;7(7):CD012543. doi: 10.1002/14651858.CD012543.pub2.
- Background: PubMed 26978655Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
- Derived from this study: PubMed 40184417Peniche PDC, Lennon O, Magalhaes JP, Dos Santos JM, Polese JC, Faria CDCM. Telehealth intervention involving the HEARTS Technical Package and the additional use of an activity monitor to increase physical activity level post-stroke: Protocol for a feasibility randomized controlled trial. PLoS One. 2025 Apr 4;20(4):e0320026. doi: 10.1371/journal.pone.0320026. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Christina Faria, PhD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®) and Telehealth intervention: HEARTS technical package in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Faria, PhD (+55 (31) 34097448, cdcmf@ufmg.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: At enrolment and allocation.). The study lists 7 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 NCT06068036, which also lists 5 linked publications.
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 27 Feb 2025.