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NCT Number: NCT06068036

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location status: Recruiting

Location contact

Christina Faria, PhD

CONTACT

[email protected]

+55 (31) 34097448

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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.

Telehealth intervention: HEARTS technical package

Behavioral

The same intervention as the experimental group, but without the additional use of the physical activity monitor (Smartwatch Mi Band 7®).

Primary outcomes

  1. Feasibility of recruitment

    Time frame: At enrolment and allocation.

    It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).

  2. Feasibility of intervention (retention)

    Time frame: At allocation and post-intervention (week-12).

    It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.

  3. Feasibility of intervention (follow-up of individuals)

    Time frame: At allocation, post-intervention (week-12), and one month after the end of the intervention (week-16).

    It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated.

  4. Feasibility of intervention (attendance)

    Time frame: At allocation and post-intervention (week-12).

    It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.

  5. Feasibility of intervention (safety)

    Time frame: During the intervention (12 weeks) and follow-up (4 weeks).

    It will be determined by the number and reasons of adverse events (e.g. pain, falls, hospitalization, and death) identified during the period of intervention and follow-up of the individual.

  6. Feasibility of intervention (perceived effectiveness)

    Time frame: At post-intervention (week-12).

    It will be determined by the following question: "Comparing how it was before you carried out the intervention and now, do you think that your ability to perform routine physical activity is: much worse, moderately worse, a little worse, the same, a little better, moderately better, or very better?".

  7. Feasibility of measurement

    Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).

    It will be determined by the percentage of clinical outcomes measured (ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured), and the percentage of participants who filled-out the diary (ratio between the number of individuals who filled-out the diary and the number of individuals who started the proposed intervention program).

Secondary outcomes

  1. Physical activity level

    Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).

    Human Activity Profile (HAP). One of the outcomes provided by the instrument is the Maximum Activity Score (MAS). From the MAS, the Adjusted Activity Score (AAS) can be found by subtracting from the MAS the number of activities that the individual provided as the answer "I stopped doing". Higher scores indicate better outcome.

  2. Number of post-stroke individuals who became physically active

    Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).

    Human Activity Profile (HAP). One of the measures provided by the questionnaire is the "Activity Rating", which provides an overall rating of the respondent's activity level into "Inactive", "Moderately active" and "Active".

  3. Systolic and diastolic blood pressure

    Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).

    Tycos® aneroid sphygmomanometer (WelchAllyn Inc., NY, USA, Model DS44) and stethoscope (Litmann Classic II SE 3M®, USA).

  4. Lifestyle-related energy consumption

    Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).

    Human Activity Profile (HAP). One of the measures provided by the questionnaire is the "Lifestyle-related energy consumption", which provides a measure of actual oxygen consumption estimated from the "Activity Adjusted Score" (AAS). This measure is operationalized in ml.kg-1.min-1. Higher scores indicate better outcome.

  5. Self-efficacy for physical activity

    Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).

    Self-efficacy for Physical Activity Scale. The scale has 10 items and has two response options: "Yes" is computed as 1 and "No" is computed as 0. The total score is defined by the sum of the scores for each item. The minimum total score is 0 and the maximum total score is 10. The higher the total score, the higher the self-efficacy for physical activity.

  6. Health-related quality of life

    Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).

    Stroke Specific Quality of Life Scale (SS-QOL). The scale has 49 items across 12 domains (items are rated on a 5-point Likert scale) and has three different sets of responses (indicated on the scale). The total score is defined by the sum of the scores for each item. The minimum total score is 49 and the maximum total score is 245. The higher the total score, the better the health-related quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Faria, PhD

CONTACT

[email protected]

+55 (31) 34097448

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do estado de Minas Gerais
  • Worldwide Universities Network

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 5, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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