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

Official 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

Overview

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.

Interventions

• 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 ins
• 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®).

Primary outcome measures

• Feasibility of recruitment [Time frame: At enrolment and allocation.]
• Feasibility of intervention (retention) [Time frame: At allocation and post-intervention (week-12).]
• 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).]
• Feasibility of intervention (attendance) [Time frame: At allocation and post-intervention (week-12).]
• Feasibility of intervention (safety) [Time frame: During the intervention (12 weeks) and follow-up (4 weeks).]
• Feasibility of intervention (perceived effectiveness) [Time frame: At post-intervention (week-12).]
• Feasibility of measurement [Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).]

Secondary outcome measures (6)

• Physical activity level [Time frame: 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 [Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).]
• Systolic and diastolic blood pressure [Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).]
• Lifestyle-related energy consumption [Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).]
• Self-efficacy for physical activity [Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).]
• Health-related quality of life [Time frame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Universidade Federal de Minas Gerais — Belo Horizonte

Publications

• 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 PMID 34140063
• 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 Ass PMID 34024117
• Lynch EA, Jones TM, Simpson DB, Fini NA, Kuys SS, Borschmann K, Kramer S, Johnson L, Callisaya ML, Mahendran N, Janssen H, English C; ACTIOnS Collaboration. Activity monitors for increasing physical activity in adult stroke survivors. Cochrane Database Syst Rev. 2018 Jul 27;7(7):CD012543. doi: 10.1002/14651858.CD012543.pub2. PMID 30051462
• 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
• 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

Identifiers

NCT: NCT06068036 · CAAE: 66980723.2.0000.5149

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗