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

Last updated: February 25, 2025
Sponsor: Federal University of Minas Gerais
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Treatment

Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®)

Telehealth intervention: HEARTS technical package

Clinical Study ID

NCT06068036
CAAE: 66980723.2.0000.5149
  • Ages > 18
  • All Genders

Study 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

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

Exclusion Criteria:

  • Positive screening test for possible cognitive alterations;

  • Pain or other adverse health condition that compromises the performance of theproposed intervention program, such as vestibular disorders, severe arthritis or anyother diagnosis of disease of the nervous system.

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®)
Phase:
Study Start date:
September 27, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais 31270-901
    Brazil

    Active - Recruiting

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