StrokeNCT04084002
Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke
An observational study of Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- physical activity measurement
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2019to 16 Nov 2019
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with stroke and their age and sex matched controls
Who may be able to join
- Patient group
- Patients with first ever, unilateral stroke
- Patients with stroke who can walk independently or with an assistive device
- Being at between the ages of 40-80 Control group
- 1. Being at between the ages of 40-80 and having not previously diagnosed with any neurologic disease
Who cannot join
- Patient group
- Having uncontrolled hypertension, cardiopulmonary disease
- Presence of neglect, dementia, apraxia
- Mini mental scale >24 or being able to complete study outcomes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, 34899
Naime Evrim Karadag Saygi, Prof, 00902166570606 ext. 1628
Esra G Giray, MD, 00902166570606 ext. 1628
About this study
Official title: Evaluation of Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke
The aim of this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population.
Read the detailed description
The aim of this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population. It is a fact that the physical activity levels of individuals decrease significantly after stroke. However, there is no study examining to what extent the physical activity is affected and the factors related to the decrease in the level of physical activity. The primary aim of stroke rehabilitation is to recognize and prevent complications, to minimize disturbances, to maximize functions. Secondary objectives; to prevent stroke recurrence. Physical activity has been shown to reduce the risk of stroke, stroke severity and other consequences. The risk of a reduction in physical capacity occurs over time and it is assumed that normal physical activity can prevent recurrent stroke. Therefore, it is necessary to continuously assess physical activity levels after stroke. In order to increase physical activity levels, it is important to identify people with low levels of physical activity and to understand the factors that may be associated. Therefore, in this study, we aimed to provide a comprehensive analysis by including most of the factors that may be related to physical activity in patients with stroke. In this study, unlike previous studies on physical activity in stroke, the relationships between physical activity and factors such as motor function, quality of life and cognitive skills as well as balance measurements and walking speed parameters which will be obtained from computerised posturography will be examined. In previous studies Physical Activity Scale for Elderly (PASE) questionnaire or the accelerometer device are used for the measurement of physical activity level. In this study, both of these tools will be used and the correlation between these two assessment tools will be demonstrated. In this study, patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday) for physical activity and Mini Mental test for cognitive function, Fugl Meyer Scale for motor function, Berg Balance Test and computerized posturography analysis for balance, Barthel Index for daily activities, Stroke Impact Scale for quality of life, Brunnstrom stage for motor recovery status. Each of the tests lasts about 5-10 minutes. Healthy control group will also be assessed via accelerometer and PASE questionnaire for physical activity and computerized posturography for balance.
With this study, physical activity which is protective for recurrent stroke, will be evaluated comprehensively and factors associated with physical activity will be revealed. Thus, in order to increase the physical activity, it will be concluded which factor should be treated or evaluated, and these results will be very helpful for further studies.
- Conditions
- Stroke
- Being tested
- physical activity measurement
- Keywords
- stroke, physical activity
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity measurementOther
Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)
| Study group | Role | What they receive |
|---|---|---|
| Patients with subacute chronic stroke | Patients with subacute chronic stroke Receives: Other: physical activity measurement | |
| Control group | Healthy control group age and sex matched Receives: Other: physical activity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACtotal
Total activity count (AC) obtained from accelerometer
Measured: Day 0
EEtotal
Total energy expenditure (EE) obtained from accelerometer
Measured: Day 0
PASE
Physical Activity Score for Elderly (PASE)
Measured: Day 0
Secondary outcomes (30)
AC moderate
activity counts derived from accelerometer during moderate physical activity
Measured: Day 0
EE moderate
energy expenditure obtained from accelerometer during moderate physical activity
Measured: Day 0
AC light
activity counts derived from accelerometer during light physical activity
Measured: Day 0
EE light
energy expenditure obtained from accelerometer during light physical activity
Measured: Day 0
AC vigorous
activity counts derived from accelerometer during vigorous physical activity
Measured: Day 0
EE vigorous
energy expenditure obtained from accelerometer during vigorous physical activity
Measured: Day 0
AC sedentary
activity counts derived from accelerometer during sedentary physical activity
Measured: Day 0
EE sedentary
energy expenditure obtained from accelerometer during sedentary physical activity
Measured: Day 0
step count
total step count obtained from accelerometer
Measured: Day 0
Stroke Impact Scale
Stroke Impact Scale
Measured: Day 0
Berg Balance Score
Berg Balance Score
Measured: Day 0
Barthel Index for Activities of Daily Living
Barthel Index for Activities of Daily Living
Measured: Day 0
FMA-UE
The Fugl-Meyer Assessment for upper extremity
Measured: Day 0
FMA-LE
The Fugl-Meyer Assessment for lower extremity
Measured: Day 0
FMA-total
The Fugl-Meyer Assessment total score
Measured: Day 0
Brunnstrom stage for proximal upper extremity
Brunnstrom stage for proximal upper extremity
Measured: Day 0
Brunnstrom stage for distal upper extremity
Brunnstrom stage for distal upper extremity
Measured: Day 0
Brunnstrom stage for lower extremity
Brunnstrom stage for lower extremity
Measured: Day 0
FAS stage
Functional Ambulation Scale (FAS) stage
Measured: Day 0
Mini Mental Test
Mini Mental Test
Measured: Day 0
stroke duration
stroke duration
Measured: Day 0
WA step width
Walk Across step width obtained from Neurocom forceplate
Measured: Day 0
WA step length
Walk Across step width obtained from Neurocom forceplate
Measured: Day 0
WA walking speed
Walk Across walking speed obtained from Neurocom forceplate
Measured: Day 0
Modified Clinical Test of Sensory Interaction on Balance
Modified Clinical Test of Sensory Interaction on Balance obtained from Neurocom forceplate
Measured: Day 0
LOS RT
Limits of Stability reaction time obtained from Neurocom forceplate
Measured: Day 0
LOS VL
Limits of Stability movement velocity obtained from Neurocom forceplate
Measured: Day 0
LOS EPE
Limits of Stability endpoint excursion obtained from Neurocom forceplate
Measured: Day 0
LOS MXE
Limits of Stability maximum excursion obtained from Neurocom forceplate
Measured: Day 0
LOS DCL
Limits of Stability directional control obtained from Neurocom forceplate
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start16 Sep 2019
- Primary completion15 Nov 2019 (estimated)
- Study completion16 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag Saygi, Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084002
- Sponsor's protocol ID
- 17.12.2018-242
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Danielsson A, Meirelles C, Willen C, Sunnerhagen KS. Physical activity in community-dwelling stroke survivors and a healthy population is not explained by motor function only. PM R. 2014 Feb;6(2):139-45. doi: 10.1016/j.pmrj.2013.08.593. Epub 2013 Aug 23.
PubMed 23978463Lacroix J, Daviet JC, Borel B, Kammoun B, Salle JY, Mandigout S. Physical Activity Level Among Stroke Patients Hospitalized in a Rehabilitation Unit. PM R. 2016 Feb;8(2):97-104. doi: 10.1016/j.pmrj.2015.06.011. Epub 2015 Jun 21.
PubMed 26107540
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke
- ClinicalTrials.gov ID
- NCT04084002
- Acronym / sponsor ID
- 17.12.2018-242
- Conditions
- Stroke
- Keywords
- stroke, physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 16 Nov 2019 (estimated)
- First posted
- 10 Sep 2019 (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 this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population.
Detailed description
The aim of this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population. It is a fact that the physical activity levels of individuals decrease significantly after stroke. However, there is no study examining to what extent the physical activity is affected and the factors related to the decrease in the level of physical activity. The primary aim of stroke rehabilitation is to recognize and prevent complications, to minimize disturbances, to maximize functions. Secondary objectives; to prevent stroke recurrence. Physical activity has been shown to reduce the risk of stroke, stroke severity and other consequences. The risk of a reduction in physical capacity occurs over time and it is assumed that normal physical activity can prevent recurrent stroke. Therefore, it is necessary to continuously assess physical activity levels after stroke. In order to increase physical activity levels, it is important to identify people with low levels of physical activity and to understand the factors that may be associated. Therefore, in this study, we aimed to provide a comprehensive analysis by including most of the factors that may be related to physical activity in patients with stroke. In this study, unlike previous studies on physical activity in stroke, the relationships between physical activity and factors such as motor function, quality of life and cognitive skills as well as balance measurements and walking speed parameters which will be obtained from computerised posturography will be examined. In previous studies Physical Activity Scale for Elderly (PASE) questionnaire or the accelerometer device are used for the measurement of physical activity level. In this study, both of these tools will be used and the correlation between these two assessment tools will be demonstrated. In this study, patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday) for physical activity and Mini Mental test for cognitive function, Fugl Meyer Scale for motor function, Berg Balance Test and computerized posturography analysis for balance, Barthel Index for daily activities, Stroke Impact Scale for quality of life, Brunnstrom stage for motor recovery status. Each of the tests lasts about 5-10 minutes. Healthy control group will also be assessed via accelerometer and PASE questionnaire for physical activity and computerized posturography for balance.
With this study, physical activity which is protective for recurrent stroke, will be evaluated comprehensively and factors associated with physical activity will be revealed. Thus, in order to increase the physical activity, it will be concluded which factor should be treated or evaluated, and these results will be very helpful for further studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with subacute chronic stroke | – | Other: physical activity measurementPatients with subacute chronic stroke |
| Control group | – | Other: physical activity measurementHealthy control group age and sex matched |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke and their age and sex matched controls
Key inclusion criteria (5 listed)
- Patient group
- Patients with first ever, unilateral stroke
- Patients with stroke who can walk independently or with an assistive device
- Being at between the ages of 40-80 Control group
- 1. Being at between the ages of 40-80 and having not previously diagnosed with any neurologic disease
Key exclusion criteria (4 listed)
- Patient group
- Having uncontrolled hypertension, cardiopulmonary disease
- Presence of neglect, dementia, apraxia
- Mini mental scale >24 or being able to complete study outcomes
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 measurementPhysical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly) | Other | Control group, Patients with subacute chronic stroke |
Primary outcome
ACtotal
Time frame: Day 0
Total activity count (AC) obtained from accelerometer
EEtotal
Time frame: Day 0
Total energy expenditure (EE) obtained from accelerometer
PASE
Time frame: Day 0
Physical Activity Score for Elderly (PASE)
30 secondary outcomes
AC moderate
Time frame: Day 0
EE moderate
Time frame: Day 0
AC light
Time frame: Day 0
EE light
Time frame: Day 0
AC vigorous
Time frame: Day 0
EE vigorous
Time frame: Day 0
AC sedentary
Time frame: Day 0
EE sedentary
Time frame: Day 0
step count
Time frame: Day 0
Stroke Impact Scale
Time frame: Day 0
Berg Balance Score
Time frame: Day 0
Barthel Index for Activities of Daily Living
Time frame: Day 0
FMA-UE
Time frame: Day 0
FMA-LE
Time frame: Day 0
FMA-total
Time frame: Day 0
Brunnstrom stage for proximal upper extremity
Time frame: Day 0
Brunnstrom stage for distal upper extremity
Time frame: Day 0
Brunnstrom stage for lower extremity
Time frame: Day 0
FAS stage
Time frame: Day 0
Mini Mental Test
Time frame: Day 0
stroke duration
Time frame: Day 0
WA step width
Time frame: Day 0
WA step length
Time frame: Day 0
WA walking speed
Time frame: Day 0
Modified Clinical Test of Sensory Interaction on Balance
Time frame: Day 0
LOS RT
Time frame: Day 0
LOS VL
Time frame: Day 0
LOS EPE
Time frame: Day 0
LOS MXE
Time frame: Day 0
LOS DCL
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Results publication: PubMed 23978463Danielsson A, Meirelles C, Willen C, Sunnerhagen KS. Physical activity in community-dwelling stroke survivors and a healthy population is not explained by motor function only. PM R. 2014 Feb;6(2):139-45. doi: 10.1016/j.pmrj.2013.08.593. Epub 2013 Aug 23.
- Results publication: PubMed 26107540Lacroix J, Daviet JC, Borel B, Kammoun B, Salle JY, Mandigout S. Physical Activity Level Among Stroke Patients Hospitalized in a Rehabilitation Unit. PM R. 2016 Feb;8(2):97-104. doi: 10.1016/j.pmrj.2015.06.011. Epub 2015 Jun 21.
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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.
Evrim Karadag Saygi, Prof study chair
Marmara University
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 Marmara 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esra Giray, MD (+905558134394, girayesra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACtotal (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084002, which also lists 2 linked publications.
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 17 Sep 2019.