StrokeNCT06049069
Factors Affecting Physical Activity in Stroke
An observational study of Stroke, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to examine the factors affecting the physical activity of individuals with stroke and to draw attention to the importance of these factors in interventions to improve the physical activity level of individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- physical activity in stroke
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2021to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Being 18 years or older, diagnosed with ischemic or hemorrhagic stroke, at least 4 weeks have passed since the stroke, no communication and cooperation problems (Mini Mental State Test total score ≥24), ability to walk with or without an assistive device.
Who cannot join
- Having received a warning about physical activity restriction by the specialist physician,having another orthopedic or neurological problem that will affect physical activity other than stroke (bone fracture, multiple sclerosis, Parkinson's, etc.),individuals with advanced cardiovascular disease and in whom mobilization is contraindicated were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Faktors Affecting the Level of Physical Activity in Patients With Stroke
The aim of our study is to examine the factors affecting the physical activity of individuals with stroke and to draw attention to the importance of these factors in interventions to improve the physical activity level of individuals with stroke.
Read the detailed description
Stroke is the leading cause of disability and disability in adults (1). While 30% of stroke patients die within a year, one third of the survivors continue their daily lives as dependents (2). The participation of stroke individuals in physical activity is significantly lower than the general population (3). There is strong evidence to support the benefits of physical activity for both people with and without a history of stroke (4). Adequate physical activity reduces the secondary harmful changes that develop after stroke, such as skeletal muscle wasting, changes in muscle structure, loss of bone mass, and decreased cardiorespiratory capacity. Physical activity also helps prevent recurrent strokes by improving control of stroke risk factors (eg, diabetes, hypertension, dyslipidemia). In addition to medical benefits, physical activity in stroke individuals is seen as an important tool in adapting to life after stroke and in reaching the physical and social goals of the person (5). Despite the known benefits of physical activity after stroke, many studies have shown that post-stroke survivors have low levels of physical activity and are even less active than older adults with chronic non-neurological conditions. However, it is unclear which factors affect physical activity after stroke(5). There is little evidence for modifiable factors affecting objectively measured physical activity and inactivity in the chronic phase of stroke (6).
In the first meta-analysis study (7) on the subject, it was emphasized that low physical activity was associated with decreased walking ability and aerobic condition, decreased balance and depression also affected physical activity, and no relationship was found between age or other demographic variables and physical activity level. In another study, it was stated that balance, walking speed, walking capacity, quality of life and depression affect physical activity level, but age and gender did not have a significant relationship with physical activity level (8). In the last meta-analysis (5), age, gender, physical function, fatigue, falling self-efficacy, balance self-efficacy, depression and quality of life were found to be significant with post-stroke physical activity. In another study, in which it was stated that fear of falling and fatigue were not significantly predictive factors of physical activity and inactivity, it was emphasized that in order to increase physical activity in stroke patients, perceived obstacles should also be taken into account instead of focusing only on walking speed (6).
When the literature is examined, it has been seen that the evidence regarding the factors affecting physical activity after stroke is variable.The effects of demographic data such as age, gender, comorbidities, and fear of falling and fatigue on post-stroke physical activity differ between studies.The effect of the time elapsed since the stroke and the stroke factors is not fully clear.Therefore, in order to increase the success of interventions for physical activity, it is important to investigate and determine the factors affecting physical activity and to make the intervention plan in accordance with these factors.
The aim of our study is to examine the factors affecting the physical activity of individuals with stroke and to draw attention to the importance of these factors in interventions to improve the physical activity level of individuals with stroke.
- Conditions
- Stroke
- Being tested
- physical activity in stroke
- Keywords
- physical activity, fear of falling, balance, sleep quality
- Medical subject headings
- Stroke, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity in strokeDiagnostic test
physical activity in stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Scale for the Physically Disabled (PASIPD)
PASIPD is a 13-item personal report form for classification purposes, covering activities of daily living , domestic activities and professional duties in the last seven days.For each item, individuals are asked to remember the number of days these activities were performed in the last 7 days and on average how many hours a day they did these activities.The PASIPD score is found by multiplying the item coefficient determined by the developers of the questionnaire for 2-13 items with the average daily hour.The total score of PASIPD is obtained by summing the PASIPD score obtained for each item.
Measured: 7 months
Secondary outcomes (6)
Exercise Benefits/Barriers Scale
Exercise Benefits/Barriers Scale consists of 43 items in total.The scale has four answers from (4 points) to (1 point).While the lowest score that can be obtained from the scale is 43, the highest score is 172. The higher the score, the higher the individual's level of belief in the benefit of exercise.
Measured: 7 months
Berg Balance Scale (BBS)
BBS is a 14-item scale that evaluates balance and fall risk of individuals.It measures the patient's ability to maintain balance while performing static or various functional movements over a period of time.Items are scored from 0 to 4. A score of 0 means that he could not do the activity at all, while a score of 4 means that he could complete the activity independently.The highest score that can be obtained from the scale is 56.A score between 0-20 indicates a balance disorder, a score between 21-40 indicates an acceptable balance, and a score between 41-56 indicates good balance.
Measured: 7 months
International Fall Effectiveness Scale (FES-I)
FES-I is a scale that evaluates the self-confidence of elderly individuals in daily living activities and shows the level of fear of falling.FES-I consists of 16 questions assessing the fear of falling during activities of daily living (house cleaning, going up and down stairs, walking, etc.).The scale is of 4-point Likert type, and each statement is scored between 1 and 4 (1: never, 2: sometimes, 3: often, and 4: always). The higher the score, the greater the fear of falling.
Measured: 7 months
Fatigue Severity Scale (FSS)
FSS inquires about the fatigue status of the last week, including the day it was filled.The scale consists of 9 items graded from 1 (strongly disagree) to 7 (strongly agree).The FSS score is obtained by adding the scores obtained from all questions and dividing by nine. Those with an FSS score of 4 or higher are considered tired.
Measured: 7 months
Beck Depression Inventory (BDI)
The BDI measures the vegetative, emotional, cognitive, and motivational symptoms of depression. The inventory consists of 21 items, each graded between 0 and 3 points. The highest score that can be obtained from the inventory is 63. The higher the score from the inventory, the higher the person's depression level.
Measured: 7 months
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report scale that assesses a person's sleep quality and disturbance over the past month. The scale consists of 24 questions, 19 questions are answered by the individual himself, and 5 questions are answered by the spouse or roommate. Questions answered by the spouse or roommate are not included in the scoring. 18 questions of the scale are included in the scoring. These questions are divided into 7 sections: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each section is scored between 0-3 and the total score of the scale is obtained by summing the scores of the 7 sections. If the total score is above 5, sleep quality is considered poor.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start22 Nov 2021
- Primary completion10 May 2022
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saniye Aydoğan Arslan, Kırıkkale University
- Investigators
- Saniye Aydoğan arslan, Assoc. Prof., Principal investigator, Kırıkkale UniversityŞeyma Nur Cellek, Pt, Principal investigator, Kırıkkale High Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049069
- Sponsor's protocol ID
- KirikkaleUniFtr4
- Status last verified
- Feb 2024
- First submitted
- 15 Sep 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Faktors Affecting the Level of Physical Activity in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06049069
- Acronym / sponsor ID
- KirikkaleUniFtr4
- Conditions
- Stroke
- Keywords
- physical activity, fear of falling, balance, sleep quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is to examine the factors affecting the physical activity of individuals with stroke and to draw attention to the importance of these factors in interventions to improve the physical activity level of individuals with stroke.
Detailed description
Stroke is the leading cause of disability and disability in adults (1). While 30% of stroke patients die within a year, one third of the survivors continue their daily lives as dependents (2). The participation of stroke individuals in physical activity is significantly lower than the general population (3). There is strong evidence to support the benefits of physical activity for both people with and without a history of stroke (4). Adequate physical activity reduces the secondary harmful changes that develop after stroke, such as skeletal muscle wasting, changes in muscle structure, loss of bone mass, and decreased cardiorespiratory capacity. Physical activity also helps prevent recurrent strokes by improving control of stroke risk factors (eg, diabetes, hypertension, dyslipidemia). In addition to medical benefits, physical activity in stroke individuals is seen as an important tool in adapting to life after stroke and in reaching the physical and social goals of the person (5). Despite the known benefits of physical activity after stroke, many studies have shown that post-stroke survivors have low levels of physical activity and are even less active than older adults with chronic non-neurological conditions. However, it is unclear which factors affect physical activity after stroke(5). There is little evidence for modifiable factors affecting objectively measured physical activity and inactivity in the chronic phase of stroke (6).
In the first meta-analysis study (7) on the subject, it was emphasized that low physical activity was associated with decreased walking ability and aerobic condition, decreased balance and depression also affected physical activity, and no relationship was found between age or other demographic variables and physical activity level. In another study, it was stated that balance, walking speed, walking capacity, quality of life and depression affect physical activity level, but age and gender did not have a significant relationship with physical activity level (8). In the last meta-analysis (5), age, gender, physical function, fatigue, falling self-efficacy, balance self-efficacy, depression and quality of life were found to be significant with post-stroke physical activity. In another study, in which it was stated that fear of falling and fatigue were not significantly predictive factors of physical activity and inactivity, it was emphasized that in order to increase physical activity in stroke patients, perceived obstacles should also be taken into account instead of focusing only on walking speed (6).
When the literature is examined, it has been seen that the evidence regarding the factors affecting physical activity after stroke is variable.The effects of demographic data such as age, gender, comorbidities, and fear of falling and fatigue on post-stroke physical activity differ between studies.The effect of the time elapsed since the stroke and the stroke factors is not fully clear.Therefore, in order to increase the success of interventions for physical activity, it is important to investigate and determine the factors affecting physical activity and to make the intervention plan in accordance with these factors.
The aim of our study is to examine the factors affecting the physical activity of individuals with stroke and to draw attention to the importance of these factors in interventions to improve the physical activity level of individuals with stroke.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (1 listed)
- Being 18 years or older, diagnosed with ischemic or hemorrhagic stroke, at least 4 weeks have passed since the stroke, no communication and cooperation problems (Mini Mental State Test total score ≥24), ability to walk with or without an assistive device.
Key exclusion criteria (1 listed)
- Having received a warning about physical activity restriction by the specialist physician,having another orthopedic or neurological problem that will affect physical activity other than stroke (bone fracture, multiple sclerosis, Parkinson's, etc.),individuals with advanced cardiovascular disease and in whom mobilization is contraindicated were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical activity in strokephysical activity in stroke | Diagnostic test | – |
Primary outcome
Physical Activity Scale for the Physically Disabled (PASIPD)
Time frame: 7 months
PASIPD is a 13-item personal report form for classification purposes, covering activities of daily living , domestic activities and professional duties in the last seven days.For each item, individuals are asked to remember the number of days these activities were performed in the last 7 days and on average how many hours a day they did these activities.The PASIPD score is found by multiplying the item coefficient determined by the developers of the questionnaire for 2-13 items with the average daily hour.The total score of PASIPD is obtained by summing the PASIPD score obtained for each item.
6 secondary outcomes
Exercise Benefits/Barriers Scale
Time frame: 7 months
Berg Balance Scale (BBS)
Time frame: 7 months
International Fall Effectiveness Scale (FES-I)
Time frame: 7 months
Fatigue Severity Scale (FSS)
Time frame: 7 months
Beck Depression Inventory (BDI)
Time frame: 7 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saniye Aydoğan arslan, Assoc. Prof. principal investigator
Kırıkkale University
Şeyma Nur Cellek, Pt principal investigator
Kırıkkale High Specialty Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Scale for the Physically Disabled (PASIPD) (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.