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

December 26, 2022 updated by: M Luz Sanchez, University of Valencia

Assessment of the Level of Physical Activity and Sedentarism of Stroke Survivors in the Valencian Community and Development of a Specific 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Recruiting
        • University of Valencia
        • Contact:
        • Contact:
      • Valencia, Spain, 46010
        • Recruiting
        • Department of Physiotherapy. University of Valencia
        • Contact:
        • Sub-Investigator:
          • M.Arantzazu Ruescas-Nicolau, PhD
        • Sub-Investigator:
          • Sofia Pérez-Alenda, PhD
        • Sub-Investigator:
          • Gemma V. Espí-López, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-management group 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.
Other: Self-management program to increase physical activity levels
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
Active Comparator: Control group
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.
Other: Education information
Education on the importance of active lifestyle habits post-stroke.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Physical activity level at a year
Time Frame: 1 year
International Physical Activity Questionnaire (IPAQ)
1 year
Change from Baseline Sedentary time at a year
Time Frame: 1 year
ActiGraph wGT3X-BT accelerometers
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Generalitat Valenciana

Investigators

  • Principal Investigator: M.Luz Sánchez Sánchez, PhD, University of Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Anticipated)

December 20, 2025

Study Completion (Anticipated)

December 20, 2026

Study Registration Dates

First Submitted

September 10, 2020

First Submitted That Met QC Criteria

September 29, 2020

First Posted (Actual)

October 6, 2020

Study Record Updates

Last Update Posted (Actual)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 26, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV/2019/161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke Sequelae

Clinical Trials on Self-management program to increase physical activity levels

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe