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NCT Number: NCT04576598

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

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.

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiotherapy. University of Valencia, Valencia, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Self-management program to increase physical activity levels

Other

Information and Communication Technologies will be used to carry out various remote sessions. The sessions will address important issues to promote self-management of sedentary lifestyle by stroke survivors. Additionally, a peer support group will be created in order to improve adherence to the program.

Other names: Physiotherapy, Physical therapy, Physical exercise program

Education information

Other

Education on the importance of active lifestyle habits post-stroke.

Primary outcomes

  1. Change from Baseline Physical activity level at a year

    Time frame: 1 year

    International Physical Activity Questionnaire (IPAQ)

  2. Change from Baseline Sedentary time at a year

    Time frame: 1 year

    ActiGraph wGT3X-BT accelerometers

Secondary outcomes

  1. Change from Baseline Functional Mobility at a year

    Time frame: 1 year

    Timed Up and Go Test

  2. Change from Baseline Lower extremity functioning at a year

    Time frame: 1 year

    Short Physical Performance Battery (SPPB)

  3. Change from Baseline Postural stability in standing at a year

    Time frame: 1 year

    Posturography with the Wii Balance Board

  4. Change from Baseline Frailty at a year

    Time frame: 1 year

    Fried's frailty phenotype

  5. Change from Baseline Sarcopenia at a year

    Time frame: 1 year

    Bioimpedance with Tanita BC-418MA

  6. Change from Baseline Bone mineral density at a year

    Time frame: 1 year

    Ultrasound bone densitometry with Sonost3000

  7. Change from Baseline Motion analysis at a year

    Time frame: 1 year

    Inertial sensors based motion capture system Xsens-DOT

Study contacts

Contact information is provided by the study sponsor or research team.

M.Luz Sánchez Sánchez, PhD

CONTACT

[email protected]

0034963983853

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Generalitat Valenciana

Registry information

Official study title

Assessment of the Level of Physical Activity and Sedentarism of Stroke Survivors in the Valencian Community and Development of a Specific Self-management Program

Acronym: SEDMA_Stroke

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Oct 6, 2020
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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