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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06011174
Other study ID # Gurbuz03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date February 5, 2024

Study information

Verified date August 2023
Source Kirikkale University
Contact Alper K Gürbüz, master
Phone +905364014402
Email alperkemal4@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Stroke is one of the leading causes that negatively affects quality of life. The benefits of regular physical activity are well recognized. Physical activity after stroke may prevent disability and recurrence of stroke. Physical impairments seen after stroke may prevent exercise and limit subsequent recovery. According to a 2016 systematic review updated and published in the Cochrane Library, physical activity programs have positive effects on disability, physical abilities, quality of life, mood and cardiovascular. However, these effects tend to diminish unless the individual's physical activity level is maintained. Therefore, individuals who have had a stroke should be encouraged to exercise. However, it has been reported that most of the patients do not participate in exercise programs as recommended after stroke and there is a decrease in physical activity level. Previous studies have reported that approximately 77% of patients with stroke are sedentary or have low levels of physical activity and also reduced frequency of physical activity. This may be a consequence of the reduced movement speed seen due to severe motor impairments. Interestingly, even those with mild motor impairments, i.e. those walking at speeds above 0.8 m/s and able to participate in community-based exercises, were found to have low levels of physical activity. Therefore, environmental and personal factors can also be barriers to exercise. Research supports the use of the theoretical model of behavior change developed by Prochaska et al. in physical activity promotion. Individuals are thought to progress through the stages of change at different rates. The concepts of self-efficacy and decision balance (perceived benefits and barriers) are particularly salient for individuals in the pre-thinking and thinking stages. Therefore, identifying and understanding perceived barriers to engaging in physical activity is an important step in creating change in physical activity behaviors. The International Classification of Functioning, Disability and Health defines functioning and disability as multidimensional concepts in which activity, especially physical activity, is influenced by organic and contextual factors. These dimensions often change after stroke and create multiple barriers that may prevent the patient from returning to a physically active lifestyle. Previous studies on barriers to physical activity in stroke survivors have used open-ended questionnaires. When we look at the scales examining exercise and physical activity barriers in the literature, it is seen that they were developed to measure physical activity barriers in the general population and in individuals with chronic conditions. Therefore, the Barriers to Physical Activity After Stroke (BAPAS) scale was developed by Drigny et al. in 2019 to help physicians and therapists identify potential targets for future interventions and optimize clinical follow-up in stroke patients and to assess barriers to physical activity after stroke. The original scale is in French and there is also an English version. Since the scale was recently developed, there is no Turkish version and no version in other languages.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date February 5, 2024
Est. primary completion date December 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 1. Being 18 years of age or older, 2. being diagnosed with hemorrhagic or ischemic stroke, 3. No cooperation and communication problems 4. Being able to walk independently Exclusion Criteria: - 1. Having another neurological or orthopedic problem other than stroke that may affect functionality, ambulation and balance 2. Individuals with advanced cardiovascular disease that may prevent physical activity and contraindications for mobilization will not be included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
survey application
Participants will only be asked to fill out the questionnaires.

Locations

Country Name City State
Turkey Kirikkale University Kirikkale

Sponsors (1)

Lead Sponsor Collaborator
Kirikkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary the Barriers to Physical Activity After Stroke (BAPAS) SCALE The necessary permissions were obtained from the authors of the BAPAS, whose validity and reliability features were to be tested, and the questionnaire was finalized by completing the translation process into Turkish. What is essential in the use of special tools such as scales is to prove the usability of the tool in the sample group to which it will be applied. The first step for this is the translation from the original language to the other language. At this stage, it is ideal to have a good knowledge of the structure of the target language and the original language.
is to have competent and experienced people do the translation
10 minute
Secondary The Barthel Activities of Daily Living Index (BADLI) SURVEY 5 minute
Secondary The Rivermead motor assessment (RMA) SURVEY 2 minute
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