NCT06068036 Telehealth Intervention Involving HEARTS Technical Package and Activity Monitor to Promote Physical Activity Post-stroke
| NCT ID | NCT06068036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Minas Gerais |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-09-27 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-09-27 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Christina Faria, PhD
PRINCIPAL INVESTIGATOR
Federal University of Minas Gerais
Frequently Asked Questions
Who can join the NCT06068036 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06068036 currently recruiting?
Yes, NCT06068036 is actively recruiting participants. Contact the research team at cdcmf@ufmg.br for enrollment information.
Where is the NCT06068036 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil.
Who is sponsoring the NCT06068036 clinical trial?
NCT06068036 is sponsored by Federal University of Minas Gerais. The principal investigator is Christina Faria, PhD at Federal University of Minas Gerais. The trial plans to enroll 24 participants.
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