NCT06011174

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

March 14, 2025

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

August 21, 2023

Last Update Submit

March 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The Barthel Activities of Daily Living Index (BADLI)

    5 minute

  • The Rivermead motor assessment (RMA)

    2 minute

Study Arms (1)

post-stroke patient

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

Other: survey application

Interventions

Participants will only be asked to fill out the questionnaires.

post-stroke patient

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A standard probability in their use of validity and reliability is unlikely. Generally, it states that at least 3 or 5-10 people should be recruited for each lime substance in lime studies (1,2). For this reason, since the Turkish version of the Post-Stroke Physical Activity Barriers Scale, which consists of 14 items, contains the validity and reliability, it is planned to enroll 70 people with stroke, whose item approach is 5 times higher. Patients coming to Kırıkkale University Faculty of Medicine Physical Therapy and Rehabilitation Hospital will be included in the study.

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University

Kırıkkale, Kırıkkale, 71450, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeSedentary Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research asistant

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

June 1, 2023

Primary Completion

December 15, 2023

Study Completion

February 5, 2024

Last Updated

March 14, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

Locations