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

NCT06068036 | Recruiting

• 1 other identifier: CAAE: 66980723.2.0000.5149
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Physical activity; Telehealth; Feasibility Study; Randomized controlled trial

Outcome Measures

Primary Outcomes (7)

• Feasibility of recruitment

  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).

  At enrolment and allocation.

• Feasibility of intervention (retention)

  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.

  At allocation and post-intervention (week-12).

• Feasibility of intervention (follow-up of individuals)

  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.

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

• Feasibility of intervention (attendance)

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

  At allocation and post-intervention (week-12).

• Feasibility of intervention (safety)

  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.

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

• Feasibility of intervention (perceived effectiveness)

  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?".

  At post-intervention (week-12).

• Feasibility of measurement

  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).

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

Secondary Outcomes (6)

• Physical activity level

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

• Number of post-stroke individuals who became physically active

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

• Systolic and diastolic blood pressure

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

• Lifestyle-related energy consumption

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

• Self-efficacy for physical activity

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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®)

Control group

ACTIVE COMPARATOR

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

Interventions

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.

Experimental group

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®).

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenaçao de Aperfeiçoamento de Pessoal de Nível Superior: collaborator
• Worldwide Universities Network: collaborator

Study Sites (1)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

RECRUITING

Related Publications (5)

• Gladstone DJ, Lindsay MP, Douketis J, Smith EE, Dowlatshahi D, Wein T, Bourgoin A, Cox J, Falconer JB, Graham BR, Labrie M, McDonald L, Mandzia J, Ngui D, Pageau P, Rodgerson A, Semchuk W, Tebbutt T, Tuchak C, van Gaal S, Villaluna K, Foley N, Coutts S, Mountain A, Gubitz G, Udell JA, McGuff R, Heran MKS, Lavoie P, Poppe AY; Canadian Stroke Consortium. Canadian Stroke Best Practice Recommendations: Secondary Prevention of Stroke Update 2020. Can J Neurol Sci. 2022 May;49(3):315-337. doi: 10.1017/cjn.2021.127. Epub 2021 Jun 18.

  PMID: 34140063 BACKGROUND

• Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.

  PMID: 34024117 BACKGROUND

• Abe H, Orita M, Arichi S. Erythrocyte deformability in aging. Mech Ageing Dev. 1984 Oct 31;27(3):383-90. doi: 10.1016/0047-6374(84)90060-5.

  PMID: 6513611 BACKGROUND

• Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.

  PMID: 26978655 BACKGROUND

• Peniche PDC, Lennon O, Magalhaes JP, Dos Santos JM, Polese JC, Faria CDCM. Telehealth intervention involving the HEARTS Technical Package and the additional use of an activity monitor to increase physical activity level post-stroke: Protocol for a feasibility randomized controlled trial. PLoS One. 2025 Apr 4;20(4):e0320026. doi: 10.1371/journal.pone.0320026. eCollection 2025.

  PMID: 40184417 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Christina Faria, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Faria, PhD

CONTACT

+55 (31) 34097448; cdcmf@ufmg.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 5, 2023
• Study Start: September 27, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)