NCT04576598 Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program
| NCT ID | NCT04576598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Valencia |
| Condition | Stroke Sequelae |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2020-01-10 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2020-01-10 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stroke is the third leading cause of disability worldwide. Women present a higher incidence of this pathology and prevalence of its risk factors. Similarly, after stroke, women have a poorer functional outcome, higher rates of institutionalization and greater dependence on activities of daily living. People who have suffered a stroke are at increased risk of cardiovascular disease, with an estimated one-third of stroke survivors suffering a new event in the following 5 years. Current scientific literature recommends the promotion of physical activity (PA) and exercise for the prevention of stroke and its sequelae. However, stroke survivors are often insufficiently active. Therefore, changing their behavior with respect to PA and sedentary lifestyle is fundamental. Moreover, gender perspective, should also taken into account. Thus, our aims are to study whether there are differences in women with chronic stroke sequelae compared to men in: 1) the amount of sitting time and its context, as well as the time spent in different intensities of PA; 2) the reduction of sitting time and its effect on health after the completion of the PA self-management program and sedentary lifestyle developed in this project; 3) the presence of sarcopenia, osteoporosis and the state of frailty. To achieve these objectives, the lifestyle habits of 128 subjects (64 women) who live in the community and have chronic sequelae of stroke (≥ 6 months) will be evaluated. In addition, possible differences in the study variables will be verified with control people without sequelae of stroke. Moreover, in order to reduce the risks of stroke survivors, a program of self-management of PA and sedentary lifestyle will be developed. This program will be carried out through several sessions spread over six months that will incorporate: education, goal setting, identification of barriers, self-control and feedback. The feasibility of this intervention will be determined by examining compliance, duration, utility, and safety. At least 64 of the previously studied subjects will participate in this program, analyzing whether it favors the reduction of sitting time and its effect on health thanks to the measurement of different physical capacities. The differences between men and women in response to the program will be determined. Finally, we will explore whether the effect of the program is greater when it is implemented in the subacute than in the chronic phase.
Eligibility Criteria
Inclusion Criteria: * having sequelae after stroke of at least 6 months of evolution * being community-dwelling (minimum 2 months since the last stroke) * having the ability to walk around the house with or without technical aids but without requiring supervision from another person (FACHS ≥ 2) * having enough cognitive capacity to provide informed consent and to understand and answer the questions proposed Exclusion Criteria: * not having a strength deficit in the lower limbs or walking difficulties * having poor vital prognosis or suffering from other pathologies or disorders that may alter the development of the study (blindness, severe sensitivity alteration, musculoskeletal or cardiovascular conditions that contraindicate the performance of physical activity...)
Contact & Investigator
M.Luz Sánchez Sánchez, PhD
PRINCIPAL INVESTIGATOR
University of Valencia
Frequently Asked Questions
Who can join the NCT04576598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Stroke Sequelae. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04576598 currently recruiting?
Yes, NCT04576598 is actively recruiting participants. Contact the research team at M.Luz.Sanchez@uv.es for enrollment information.
Where is the NCT04576598 trial being conducted?
This trial is being conducted at Valencia, Spain, Valencia, Spain.
Who is sponsoring the NCT04576598 clinical trial?
NCT04576598 is sponsored by University of Valencia. The principal investigator is M.Luz Sánchez Sánchez, PhD at University of Valencia. The trial plans to enroll 128 participants.
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