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Telehealth Intervention Involving HEARTS Technical Package and Activity Monitor to Promote Physical Activity Post-stroke

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 27, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Sep 30, 2024 to Jul 2025
    • Study completion date: Dec 31, 2024 to Jul 2025
    • Collaborators reordered
    v3
  2. Notable Primary endpoints: 2 to 7v2 Show 4 more changesShow less
    • Enrollment target: 34 to 24
    • Secondary endpoints: 4 to 6
    • Study description shortened, about 34 words
    • Publications: 4 to 5
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06068036
Lead Sponsor Federal University of Minas Gerais
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
Conditions
(from sponsor)
Stroke
Related terms Motor Activity, Stroke
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov