NCT06068036

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
BEHAVIORAL	Telehealth intervention: HEARTS technical package	The same intervention as the experimental group, but without the additional use of the physical activity monitor (Smartwatch Mi Band 7®).

Timeline

• Start date: 2023-09-27
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-10-05
• Last updated: 2025-02-27

Locations

1 site across 1 country: Brazil