Sedentarism of Stroke Survivors in the Valencian Community and Development of a Self-management Program

Not Applicable

Recruiting

• Conditions: Stroke Sequelae
• Interventions: Other: Self-management program to increase physical activity levels; Other: Education information

• Registration Number: NCT04576598
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-10
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-06
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-26
• Last Update Posted: 2022-12-28
• Primary Completion: 2025-12-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management group to increase physical activity levels	Self-management program to increase physical activity levels	This group will perform a self-management program along 6 months. This program will aim to increase the level of physical activity and adherence to healthier lifestyle habits and will be carried out through several sessions that will incorporate: education, goal setting, identification of barriers, self-control and feedback.
Control group	Education information	This group will participate in the initial educational session and will be given a leaflet with recommendations for physical activity to follow throughout the six months.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Physical activity level at a year	1 year	International Physical Activity Questionnaire (IPAQ)
Change from Baseline Sedentary time at a year	1 year	ActiGraph wGT3X-BT accelerometers

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Functional Mobility at a year	1 year	Timed Up and Go Test
Change from Baseline Lower extremity functioning at a year	1 year	Short Physical Performance Battery (SPPB)
Change from Baseline Postural stability in standing at a year	1 year	Posturography with the Wii Balance Board
Change from Baseline Frailty at a year	1 year	Fried's frailty phenotype
Change from Baseline Sarcopenia at a year	1 year	Bioimpedance with Tanita BC-418MA
Change from Baseline Bone mineral density at a year	1 year	Ultrasound bone densitometry with Sonost3000
Change from Baseline Motion analysis at a year	1 year	Inertial sensors based motion capture system Xsens-DOT

Trial Locations

Locations (2)

Department of Physiotherapy. University of Valencia; 🇪🇸 Valencia, Spain

University of Valencia; 🇪🇸 Valencia, Spain