Clinical trial NCT06068036: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Physical activity
Telehealth
Feasibility Study
Randomized controlled trial
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenaçao de Aperfeiçoamento de Pessoal de Nível Superior
name: Worldwide Universities Network
First posted: 2023-10-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: At enrolment and allocation.
measure: Feasibility of intervention (retention)
timeFrame: At allocation and post-intervention (week-12).
measure: Feasibility of intervention (follow-up of individuals)
timeFrame: At allocation, post-intervention (week-12), and one month after the end of the intervention (week-16).
measure: Feasibility of intervention (attendance)
timeFrame: At allocation and post-intervention (week-12).
measure: Feasibility of intervention (safety)
timeFrame: During the intervention (12 weeks) and follow-up (4 weeks).
measure: Feasibility of intervention (perceived effectiveness)
timeFrame: At post-intervention (week-12).
measure: Feasibility of measurement
timeFrame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Secondary outcomes:
measure: Physical activity level
timeFrame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
measure: Number of post-stroke individuals who became physically active
timeFrame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
measure: Systolic and diastolic blood pressure
timeFrame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
measure: Lifestyle-related energy consumption
timeFrame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
measure: Self-efficacy for physical activity
timeFrame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
measure: Health-related quality of life
timeFrame: At baseline, post-intervention (week-12), and one month after the end of the intervention (week-16).
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Christina Faria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.