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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Recruiting

CT.gov ID

NCT06068036

Collaborator

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

Enrollment

Location

Arms

15.1

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: Stroke secondary prevention guidelines point out that post-stroke individuals often present sedentary or inactive behavior and, therefore, should be encouraged to practice physical activity. Behavior change interventions, such as to encourage physical activity practice, must be theoretically informed and can be implemented remotely. However, systematic reviews about telehealth interventions do not consolidate evidence regarding the use of these interventions to promote physical activity with post-stroke individuals.

Objectives: The primary aim of this study is to investigate the effect of telehealth intervention involving the HEARTS technical package and the use of an activity monitor to promote physical activity with post-stroke individuals. The secondary aim of this study is to investigate the effect of the previously mentioned intervention in reducing systolic and diastolic blood pressure, increasing lifestyle-related energy consumption, improving self-efficacy for physical activity and health-related quality of life of post-stroke individuals.

Design: A randomized controlled trial 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 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. Measurements will be performed at baseline (week 0), after the end of the intervention program (week 12) and one month after the end of the intervention program (week 16).

Study Outcomes: Primary outcome is the physical activity level and the number of individuals post-stroke who became physically active. Secondary outcomes are systolic and diastolic blood pressure, lifestyle-related energy consumption, self-efficacy for physical activity and health-related quality of life.

Conclusion: The results of this trial will provide valuable new information on the effect of the previously mentioned intervention to promote physical activity with post-stroke individuals, as well in reducing systolic and diastolic blood pressure, increasing lifestyle-related energy consumption, improving self-efficacy for physical activity and health-related quality of life of these individuals.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Behavioral: Telehealth intervention: HEARTS technical package + activity monitor (Smartwatch Mi Band 7®) Behavioral: Telehealth intervention: HEARTS technical package	N/A

Detailed Description

Sample size calculation: Teixeira-Salmela et al. (1999) investigated the effect of muscle strengthening and physical conditioning to reduce impairment and disability in post-stroke individuals and used the Adjusted Activity Score (AAS) of the Human Activity Profile (HAP) to assess the physical activity level. Considering a significance level of 5%, a desired power of 80%, a difference in means post intervention between experimental e control group for AAS of 11.93 and a standard deviation of this outcome variable of 10.03, and an expected dropout rate of 30%, the minimum number of participants needed was 17 participants per group (total of 34).

Statistical analyzes: All statistical analyzes will be performed by an independent examiner, blinded to the group allocation. Each participant will assign with a unique code. All analyzes will be performed using SPSS (SPSS Inc., Chicago, IL, USA). The normality of data distribution will be performed for all continuous numeric variables. Descriptive statistics will be calculated for all outcomes. The effects of the interventions will be analyzed from the collected data using intention-to-treat. Data from the last available assessment will be used for missed sessions. Two-way ANOVA with repeated measures (2*3) will be used to evaluate the differences between groups, considering the time factor (considering baseline, post-intervention, and 4-week follow-up) for the variables of interest. The level of significance will be set at 5% and adjusted for multiple comparisons. The effect sizes will be calculated to determine the magnitude of the differences between the groups.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

The collection will be performed by a previously trained examiner, blinded to the allocation of groups. All participants will be instructed not to comment on information about the training received. All statistical analyzes will be performed by an independent examiner, blinded to all procedures performed in the study, including with regard to group allocation.

Primary Purpose:

Treatment

Official Title:

Effect of Telehealth Intervention Involving the HEARTS Technical Package and the Use of an Activity Monitor to Promote Physical Activity With Post-stroke Individuals: a Randomized Clinical Trial

Actual Study Start Date :

Sep 27, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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®).	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®).

Arm

Intervention/Treatment

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.

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

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®).

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®).

Outcome Measures

Primary Outcome Measures

Physical activity level [At baseline, post-intervention (after the 12-week intervention), and one month after the end of the intervention (16-week follow-up).]
Human Activity Profile (HAP). One of the measures provided by the questionnaire is the "Activity Adjusted Score" (AAS), which provides a best estimate of the respondent's average level of energy expended.
Number of post-stroke individuals who became physically active [At baseline, post-intervention (after the 12-week intervention), and one month after the end of the intervention (16-week follow-up).]
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".

Secondary Outcome Measures

Systolic and diastolic blood pressure [At baseline, post-intervention (after the 12-week intervention), and one month after the end of the intervention (16-week follow-up).]
Tycos® aneroid sphygmomanometer (WelchAllyn Inc., NY, USA, Model DS44) and stethoscope (Litmann Classic II SE 3M®, USA).
Lifestyle-related energy consumption [At baseline, post-intervention (after the 12-week intervention), and one month after the end of the intervention (16-week follow-up).]
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).
Self-efficacy for physical activity [At baseline, post-intervention (after the 12-week intervention), and one month after the end of the intervention (16-week follow-up).]
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.
Health-related quality of life [At baseline, post-intervention (after the 12-week intervention), and one month after the end of the intervention (16-week follow-up).]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.