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
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Universidade Federal de Minas Gerais
RECRUITING
Belo Horizonte
Contact Information
Primary
Christina Faria, PhD
cdcmf@ufmg.br
+55 (31) 34097448
Time Frame
Start Date: 2023-09-27
Estimated Completion Date: 2025-07
Participants
Target number of participants: 24
Treatments
Experimental: Experimental group
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.
Active_comparator: Control group
Participants will undergo the same intervention as the experimental group, but will not receive the physical activity monitor (Smartwatch Mi Band 7®).
Related Therapeutic Areas
Sponsors
Collaborators: Coordenaçao de Aperfeiçoamento de Pessoal de Nível Superior, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Worldwide Universities Network, Fundação de Amparo à Pesquisa do estado de Minas Gerais
Leads: Federal University of Minas Gerais

This content was sourced from clinicaltrials.gov