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

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ClinicalTrials.gov Identifier: NCT04576598
Recruitment Status : Unknown
Verified September 2020 by M Luz Sanchez, University of Valencia.
Recruitment status was:  Recruiting
First Posted : October 6, 2020
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
Generalitat Valenciana
Information provided by (Responsible Party):
M Luz Sanchez, 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.


Condition or disease Intervention/treatment Phase
Stroke Sequelae Other: Self-management program to increase physical activity levels Other: Education information Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576598


Contacts
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Contact: M.Luz Sánchez Sánchez, PhD 0034963983853 M.Luz.Sanchez@uv.es

Locations
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Spain
Department of Physiotherapy. University of Valencia Recruiting
Valencia, Spain, 46010
Contact: M.Luz Sánchez-Sánchez, PhD    0034963983853    M.Luz.Sanchez@uv.es   
Sub-Investigator: M.Arantzazu Ruescas-Nicolau, PhD         
Sub-Investigator: Sofia Pérez-Alenda, PhD         
Sub-Investigator: Gemma V. Espí-López, PhD         
University of Valencia Recruiting
Valencia, Spain, 46010
Contact: Sánchez-Sánchez ML    0034-963 98 38 55    M.Luz.Sanchez@uv.es   
Contact: Ruescas-Nicolau A    0034-963 98 38 55    Arancha.Ruescas@uv.es   
Sponsors and Collaborators
University of Valencia
Generalitat Valenciana
Investigators
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Principal Investigator: M.Luz Sánchez Sánchez, PhD University of Valencia
Publications:

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Responsible Party: M Luz Sanchez, PhD, University of Valencia
ClinicalTrials.gov Identifier: NCT04576598    
Other Study ID Numbers: GV/2019/161
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases