Cerebrovascular StrokeNCT06255145
Assessment of Body Composition, Fatigue, Mobility and Functional Status in Post-Stroke Individuals
A study testing Bioelectrical Impedance Analysis in people with Cerebrovascular Stroke and Body Composition, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled trial is to evaluate body composition, fatigue, mobility level, functional status in with stroke individuals. The main questions it aims to answer are: How is body composition affected in individuals with stroke? How is the level of fatigue affected in individuals with stroke?… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Stroke, Body Composition
- What is being tested?
- Bioelectrical Impedance Analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Dec 2021to 5 Jul 2022
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Volunteering to participate in the study
- Having a score of 25 or above on the Mini Mental Test
- Getting a score between 0-3 on the Modified Rankin Scale
- Being between the ages of 30-65
- Volunteering to participate in the study
- Not having any neurological, orthopedic, rheumatologic and metabolic problems
- Having a score of 25 or above on the Mini Mental Test
Who cannot join
- Having cardiac insufficiency
- Being morbid obesity
- Having pacemaker
- Being pregnant
- Participating in any fat burning diet program
- Exercising regularly
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this randomized controlled trial is to evaluate body composition, fatigue, mobility level, functional status in with stroke individuals. The main questions it aims to answer are:
How is body composition affected in individuals with stroke? How is the level of fatigue affected in individuals with stroke? How is the mobility level affected in individuals with stroke? How is functional status affected in individuals with stroke? In this study, we included 21 patients with stroke and 21 healthy controls. The body composition of the participants was evaluated by Bioelectrical Impedance Analysis (BIA), fatigue level by Fatigue Severity Scale (FSS), mobility level by Rivermead Mobility Index (RMI), and functional status by Functional Independence Scale (FIM).
Read the detailed description
As defined by the World Health Organization, stroke is "a clinical condition that has no apparent cause other than vascular causes, lasts for 24 hours or longer, or may result in death, and is characterized by sudden focal (or global) disturbances in cerebral function. It is the third leading cause of mortality in the world after cardiovascular diseases and cancer, and ranks first in terms of causing disability.¹ In Turkey, the incidence of stroke was estimated as 125,345 (154 per hundred thousand), the prevalence as 1,080,380 (1.3 percent), the mortality rate due to stroke as 48,947 people and the number of years of life lost due to stroke-related death/disability as 993,082 years.2Approximately 795000 people have a stroke in the United States of America every year and 185000 of them relapse.3 In 2016, stroke was responsible for approximately 5.5 million deaths and 116.4 million years of quality of life loss, with a significant impact on the economy.4 Post-stroke dysphagia, visual-spatial disorientation, gastrointestinal system disorders, depression, and increased catabolic process lead to malnutrition.5 In addition to hormonal changes and immobilization, fat mass increases while lean body mass decreases in individuals with stroke (IVS).6 Besides, following stroke, factors such as inadequate calorie and macronutrient intake, denervation, disuse, spasticity, and inflammation may come together to cause sarcopenia and thereby an increase in fat mass.5,7 Additionally, the study by Li et al. concluded that muscle loss after stroke is also accompanied by an increase in intramuscular fat and bone loss.8 In IVS, loss of muscle mass causes fatigue, general weakness and lack of energy. In one study, it was stated that skeletal muscle mass should be increased to reduce fatigue in IVS.9 Fatigue is a subjectively reported lack of physical and mental energy that negatively affects daily life activities. Among stroke survivors, 40% identified fatigue as one of the worst symptoms.10 IVS have gait and balance disorders due to motor, visual-perceptual, sensory problems, spasticity, paralysis, muscle atrophy, increase in fat mass, fatigue, movement limitations, proprioceptive sensory loss and impairments in cognitive functions. This situation can negatively affect the functional status of individuals by reducing their mobility levels.11,12 In stroke rehabilitation, it is important to identify the fat mass in individuals with stroke, to determine the loss of muscle mass in parallel, to determine in which regions the fat mass level increases more significantly, and to compare the fatigue and functional losses that may occur with this increase with healthy individuals in the same age group. In the literature, we did not find any study that evaluated body composition changes, fatigue, mobility and functional status together in IVS. The present study is significant in terms of examining the body composition of IVS in detail and evaluating the extent to which body composition parameters, fatigue, mobility and functional independence levels differ when compared with healthy controls. The purpose of our study is to compare body composition, fatigue, mobility and functional status in stroke patients with healthy subjects.
- Conditions
- Cerebrovascular Stroke, Body Composition
- Being tested
- Bioelectrical Impedance Analysis
- Keywords
- Stroke, Body Composition, Fatique, Mobility, Functional Status
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioelectrical Impedance AnalysisDevice
Also called Fatigue Severity Scale, Rivermead Mobility Index, Functional Independence Scale
Bioelectrical Impedance Analysis Beurer BF 1000 Super Precision device was used to measure the body composition of the participants. Operating on the principle of BIA, the device allows the body composition to be evaluated by giving an imperceptible electric current to the body.
Fatigue Severity Scale (FSS) Fatigue Severity Scale (FSS) was used to measure participants' fatigue levels. Rivermead Mobility Index Rivermead Mobility Index (RMI) was used to assess the mobility levels of the participants.
Functional Independence Measure Functional Independence Measure (FIM) was used to evaluate the functional status of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In all participants, body composition evaluation was carried out with the Beurer BF 1000 Super Precision device using the Bioelectrical Impedance Analysis principle, fatigue evaluation was carried out with the Fatigue Severity Scale, mobility evaluation was carried out with the Rivermead Mobility Index, and functional status evaluation was carried out with the Functional Independence Scale. Receives: Device: Bioelectrical Impedance Analysis |
| Control Group | Active comparator | In all participants, body composition evaluation was carried out with the Beurer BF 1000 Super Precision device using the Bioelectrical Impedance Analysis principle, fatigue evaluation was carried out with the Fatigue Severity Scale, mobility evaluation was carried out with the Rivermead Mobility Index, and functional status evaluation was carried out with the Functional Independence Scale. Receives: Device: Bioelectrical Impedance Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioelectrical Impedance Analysis
body weight
Measured: 12 week
Bioelectrical Impedance Analysis
body fat percentage
Measured: 12 week
Bioelectrical Impedance Analysis
muscle percentage
Measured: 12 week
Bioelectrical Impedance Analysis
total water percentage
Measured: 12 week
Bioelectrical Impedance Analysis
visceral fat amount
Measured: 12 week
Bioelectrical Impedance Analysis
total bone mass
Measured: 12 week
Secondary outcomes (3)
Fatigue Severity Scale
fatique. Minimum score is 9 and maximum score is 63. Scores of 36 or more represent severe fatigue. Scale score is the mean value of the nine items. When the total score is below 4, it is considered as "not tired" and when it is above 4, it is considered as "tired".
Measured: 12 week
Rivermead Mobility Index
mobility.Total score is between 0-15. The score of 15 means that there is no problem in mobility, while a score of 14 and below means that there is a problem in mobility.
Measured: 12 week
Functional Independence Scale
functional status.It consists of 18 items under six headings: self-care, sphincter control, transfer, displacement, communication and social perception. Every item is scored between 1-7 (1 point: fully dependent, 7 points: fully independent). It is possible to get a minimum score of 18 and a maximum score of 126.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start17 Dec 2021
- Primary completion5 Jun 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular StrokeStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Based on the results of the power analysis, it was calculated that 80% power could be obtained at 95% confidence level when at least 42 people (21 people for each group) were included in the study all participants, body composition evaluation was carried out with the Beurer BF 1000 Super Precision device using the Bioelectrical Impedance Analysis principle, fatigue evaluation was carried out with the Fatigue Severity Scale, mobility evaluation was carried out with the Rivermead Mobility Index, and functional status evaluation was carried out with the Functional Independence Scale.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raziye ÇELİK, Pamukkale University
- Investigators
- Raziye Çelik, PT., Principal investigator, Pamukkale UniversityEmre Baskan, Assoc Prof., Study director, Pamukkale UniversityAziz Dengiz, PT Phd, Study director, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255145
- Sponsor's protocol ID
- PamukkaleUniversityRC
- Status last verified
- Feb 2024
- First submitted
- 14 Oct 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known whether there will be a plan to roll out IPD.
Publications
Sudlow CL, Warlow CP. Comparing stroke incidence worldwide: what makes studies comparable? Stroke. 1996 Mar;27(3):550-8. doi: 10.1161/01.str.27.3.550.
PubMed 8610328Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117Siotto M, Germanotta M, Guerrini A, Pascali S, Cipollini V, Cortellini L, Ruco E, Khazrai YM, De Gara L, Aprile I. Relationship between Nutritional Status, Food Consumption and Sarcopenia in Post-Stroke Rehabilitation: Preliminary Data. Nutrients. 2022 Nov 15;14(22):4825. doi: 10.3390/nu14224825.
PubMed 36432512Purroy F, Montala N. Epidemiology of stroke in the last decade: a systematic review. Rev Neurol. 2021 Nov 1;73(9):321-336. doi: 10.33588/rn.7309.2021138. English, Spanish.
PubMed 34676530Scherbakov N, von Haehling S, Anker SD, Dirnagl U, Doehner W. Stroke induced Sarcopenia: muscle wasting and disability after stroke. Int J Cardiol. 2013 Dec 10;170(2):89-94. doi: 10.1016/j.ijcard.2013.10.031. Epub 2013 Oct 14.
PubMed 24231058Li S, Gonzalez-Buonomo J, Ghuman J, Huang X, Malik A, Yozbatiran N, Magat E, Francisco GE, Wu H, Frontera WR. Aging after stroke: how to define post-stroke sarcopenia and what are its risk factors? Eur J Phys Rehabil Med. 2022 Oct;58(5):683-692. doi: 10.23736/S1973-9087.22.07514-1. Epub 2022 Sep 5.
PubMed 36062331Su Y, Asamoto M, Yuki M, Saito M, Hasebe N, Hirayama K, Otsuki M, Iino C. Predictors and short-term outcomes of post-stroke fatigue in initial phase of transition from hospital to home: A prospective observational study. J Adv Nurs. 2021 Apr;77(4):1825-1838. doi: 10.1111/jan.14731. Epub 2020 Dec 23.
PubMed 33368578Paciaroni M, Acciarresi M. Poststroke Fatigue. Stroke. 2019 Jul;50(7):1927-1933. doi: 10.1161/STROKEAHA.119.023552. Epub 2019 Jun 14. No abstract available.
PubMed 31195940Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.
PubMed 12161823Tani Y, Otaka Y, Kudo M, Kurayama T, Kondo K. Prevalence of Genu Recurvatum during Walking and Associated Knee Pain in Chronic Hemiplegic Stroke Patients: A Preliminary Survey. J Stroke Cerebrovasc Dis. 2016 May;25(5):1153-1157. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.028. Epub 2016 Feb 19.
PubMed 26907679Mally K, Trentmann J, Heller M, Dittmar M. Reliability and accuracy of segmental bioelectrical impedance analysis for assessing muscle and fat mass in older Europeans: a comparison with dual-energy X-ray absorptiometry. Eur J Appl Physiol. 2011 Aug;111(8):1879-87. doi: 10.1007/s00421-010-1795-x. Epub 2011 Jan 14.
PubMed 21234595Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
PubMed 2803071Ozyemisci-Taskiran O, Batur EB, Yuksel S, Cengiz M, Karatas GK. Validity and reliability of fatigue severity scale in stroke. Top Stroke Rehabil. 2019 Mar;26(2):122-127. doi: 10.1080/10749357.2018.1550957. Epub 2018 Nov 26.
PubMed 30475156Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4. doi: 10.3109/03790799109166684.
PubMed 1836787Ottenbacher KJ, Hsu Y, Granger CV, Fiedler RC. The reliability of the functional independence measure: a quantitative review. Arch Phys Med Rehabil. 1996 Dec;77(12):1226-32. doi: 10.1016/s0003-9993(96)90184-7.
PubMed 8976303
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Body Composition, Fatigue, Mobility and Functional Status in Post-Stroke Individuals
- ClinicalTrials.gov ID
- NCT06255145
- Acronym / sponsor ID
- PamukkaleUniversityRC
- Conditions
- Cerebrovascular Stroke, Body Composition
- Keywords
- Stroke, Body Composition, Fatique, Mobility, Functional Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 13 Feb 2024 (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 goal of this randomized controlled trial is to evaluate body composition, fatigue, mobility level, functional status in with stroke individuals. The main questions it aims to answer are:
How is body composition affected in individuals with stroke? How is the level of fatigue affected in individuals with stroke? How is the mobility level affected in individuals with stroke? How is functional status affected in individuals with stroke? In this study, we included 21 patients with stroke and 21 healthy controls. The body composition of the participants was evaluated by Bioelectrical Impedance Analysis (BIA), fatigue level by Fatigue Severity Scale (FSS), mobility level by Rivermead Mobility Index (RMI), and functional status by Functional Independence Scale (FIM).
Detailed description
As defined by the World Health Organization, stroke is "a clinical condition that has no apparent cause other than vascular causes, lasts for 24 hours or longer, or may result in death, and is characterized by sudden focal (or global) disturbances in cerebral function. It is the third leading cause of mortality in the world after cardiovascular diseases and cancer, and ranks first in terms of causing disability.¹ In Turkey, the incidence of stroke was estimated as 125,345 (154 per hundred thousand), the prevalence as 1,080,380 (1.3 percent), the mortality rate due to stroke as 48,947 people and the number of years of life lost due to stroke-related death/disability as 993,082 years.2Approximately 795000 people have a stroke in the United States of America every year and 185000 of them relapse.3 In 2016, stroke was responsible for approximately 5.5 million deaths and 116.4 million years of quality of life loss, with a significant impact on the economy.4 Post-stroke dysphagia, visual-spatial disorientation, gastrointestinal system disorders, depression, and increased catabolic process lead to malnutrition.5 In addition to hormonal changes and immobilization, fat mass increases while lean body mass decreases in individuals with stroke (IVS).6 Besides, following stroke, factors such as inadequate calorie and macronutrient intake, denervation, disuse, spasticity, and inflammation may come together to cause sarcopenia and thereby an increase in fat mass.5,7 Additionally, the study by Li et al. concluded that muscle loss after stroke is also accompanied by an increase in intramuscular fat and bone loss.8 In IVS, loss of muscle mass causes fatigue, general weakness and lack of energy. In one study, it was stated that skeletal muscle mass should be increased to reduce fatigue in IVS.9 Fatigue is a subjectively reported lack of physical and mental energy that negatively affects daily life activities. Among stroke survivors, 40% identified fatigue as one of the worst symptoms.10 IVS have gait and balance disorders due to motor, visual-perceptual, sensory problems, spasticity, paralysis, muscle atrophy, increase in fat mass, fatigue, movement limitations, proprioceptive sensory loss and impairments in cognitive functions. This situation can negatively affect the functional status of individuals by reducing their mobility levels.11,12 In stroke rehabilitation, it is important to identify the fat mass in individuals with stroke, to determine the loss of muscle mass in parallel, to determine in which regions the fat mass level increases more significantly, and to compare the fatigue and functional losses that may occur with this increase with healthy individuals in the same age group. In the literature, we did not find any study that evaluated body composition changes, fatigue, mobility and functional status together in IVS. The present study is significant in terms of examining the body composition of IVS in detail and evaluating the extent to which body composition parameters, fatigue, mobility and functional independence levels differ when compared with healthy controls. The purpose of our study is to compare body composition, fatigue, mobility and functional status in stroke patients with healthy subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Based on the results of the power analysis, it was calculated that 80% power could be obtained at 95% confidence level when at least 42 people (21 people for each group) were included in the study all participants, body composition evaluation was carried out with the Beurer BF 1000 Super Precision device using the Bioelectrical Impedance Analysis principle, fatigue evaluation was carried out with the Fatigue Severity Scale, mobility evaluation was carried out with the Rivermead Mobility Index, and functional status evaluation was carried out with the Functional Independence Scale.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Bioelectrical Impedance AnalysisIn all participants, body composition evaluation was carried out with the Beurer BF 1000 Super Precision device using the Bioelectrical Impedance Analysis principle, fatigue evaluation was carried out with the Fatigue Severity Scale, mobility evaluation was carried out with the Rivermead Mobility Index, and functional status evaluation was carried out with the Functional Independence Scale. |
| Control Group | Active comparator | Device: Bioelectrical Impedance AnalysisIn all participants, body composition evaluation was carried out with the Beurer BF 1000 Super Precision device using the Bioelectrical Impedance Analysis principle, fatigue evaluation was carried out with the Fatigue Severity Scale, mobility evaluation was carried out with the Rivermead Mobility Index, and functional status evaluation was carried out with the Functional Independence Scale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being between the ages of 18-65
- Volunteering to participate in the study
- Having a score of 25 or above on the Mini Mental Test
- Getting a score between 0-3 on the Modified Rankin Scale
- Being between the ages of 30-65
Key exclusion criteria (7 listed)
- Having cardiac insufficiency
- Being morbid obesity
- Having pacemaker
- Being pregnant
- Participating in any fat burning diet program
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 |
|---|---|---|
| Bioelectrical Impedance AnalysisAlso: Fatigue Severity Scale, Rivermead Mobility Index, Functional Independence ScaleBioelectrical Impedance Analysis Beurer BF 1000 Super Precision device was used to measure the body composition of the participants. Operating on the principle of BIA, the device allows the body composition to be evaluated by giving an imperceptible electric current to the body. Fatigue Severity Scale (FSS) Fatigue Severity Scale (FSS) was used to measure participants' fatigue levels. Rivermead Mobility Index Rivermead Mobility Index (RMI) was used to assess the mobility levels of the participants. Functional Independence Measure Functional Independence Measure (FIM) was used to evaluate the functional status of the participants. | Device | Control Group, Experimental group |
Primary outcome
Bioelectrical Impedance Analysis
Time frame: 12 week
body weight
Bioelectrical Impedance Analysis
Time frame: 12 week
body fat percentage
Bioelectrical Impedance Analysis
Time frame: 12 week
muscle percentage
Bioelectrical Impedance Analysis
Time frame: 12 week
total water percentage
Bioelectrical Impedance Analysis
Time frame: 12 week
visceral fat amount
Bioelectrical Impedance Analysis
Time frame: 12 week
total bone mass
3 secondary outcomes
Fatigue Severity Scale
Time frame: 12 week
Rivermead Mobility Index
Time frame: 12 week
Functional Independence Scale
Time frame: 12 week
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 13 Feb 2024.
- Background: PubMed 8610328Sudlow CL, Warlow CP. Comparing stroke incidence worldwide: what makes studies comparable? Stroke. 1996 Mar;27(3):550-8. doi: 10.1161/01.str.27.3.550.
- Background: PubMed 34024117Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
- Background: PubMed 36432512Siotto M, Germanotta M, Guerrini A, Pascali S, Cipollini V, Cortellini L, Ruco E, Khazrai YM, De Gara L, Aprile I. Relationship between Nutritional Status, Food Consumption and Sarcopenia in Post-Stroke Rehabilitation: Preliminary Data. Nutrients. 2022 Nov 15;14(22):4825. doi: 10.3390/nu14224825.
- Background: PubMed 34676530Purroy F, Montala N. Epidemiology of stroke in the last decade: a systematic review. Rev Neurol. 2021 Nov 1;73(9):321-336. doi: 10.33588/rn.7309.2021138. English, Spanish.
- Background: PubMed 24231058Scherbakov N, von Haehling S, Anker SD, Dirnagl U, Doehner W. Stroke induced Sarcopenia: muscle wasting and disability after stroke. Int J Cardiol. 2013 Dec 10;170(2):89-94. doi: 10.1016/j.ijcard.2013.10.031. Epub 2013 Oct 14.
- Background: PubMed 36062331Li S, Gonzalez-Buonomo J, Ghuman J, Huang X, Malik A, Yozbatiran N, Magat E, Francisco GE, Wu H, Frontera WR. Aging after stroke: how to define post-stroke sarcopenia and what are its risk factors? Eur J Phys Rehabil Med. 2022 Oct;58(5):683-692. doi: 10.23736/S1973-9087.22.07514-1. Epub 2022 Sep 5.
- Background: PubMed 33368578Su Y, Asamoto M, Yuki M, Saito M, Hasebe N, Hirayama K, Otsuki M, Iino C. Predictors and short-term outcomes of post-stroke fatigue in initial phase of transition from hospital to home: A prospective observational study. J Adv Nurs. 2021 Apr;77(4):1825-1838. doi: 10.1111/jan.14731. Epub 2020 Dec 23.
- Background: PubMed 31195940Paciaroni M, Acciarresi M. Poststroke Fatigue. Stroke. 2019 Jul;50(7):1927-1933. doi: 10.1161/STROKEAHA.119.023552. Epub 2019 Jun 14. No abstract available.
- Background: PubMed 12161823Mayo NE, Wood-Dauphinee S, Cote R, Durcan L, Carlton J. Activity, participation, and quality of life 6 months poststroke. Arch Phys Med Rehabil. 2002 Aug;83(8):1035-42. doi: 10.1053/apmr.2002.33984.
- Background: PubMed 26907679Tani Y, Otaka Y, Kudo M, Kurayama T, Kondo K. Prevalence of Genu Recurvatum during Walking and Associated Knee Pain in Chronic Hemiplegic Stroke Patients: A Preliminary Survey. J Stroke Cerebrovasc Dis. 2016 May;25(5):1153-1157. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.028. Epub 2016 Feb 19.
- Background: PubMed 21234595Mally K, Trentmann J, Heller M, Dittmar M. Reliability and accuracy of segmental bioelectrical impedance analysis for assessing muscle and fat mass in older Europeans: a comparison with dual-energy X-ray absorptiometry. Eur J Appl Physiol. 2011 Aug;111(8):1879-87. doi: 10.1007/s00421-010-1795-x. Epub 2011 Jan 14.
- Background: PubMed 2803071Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
- Fitness ve EMS (Electromyostimulation) antrenman tekniklerinin vücut kompozisyonu üzerine etkileriLink provided by the sponsor.
- BF 1000 Super Pricision Kullanım KılavuzuLink provided by the sponsor.
- Fazla kilolu ve obez kadınlarda 30 dakika egzersiz kilo kaybı üzerine etkili midir?Link provided by the sponsor.
- Rivermead mobilite indeksi (RMI) türkçe formunun yaşlılarda geçerlilik ve güvenilirliğiLink provided by the sponsor.
- Türkiye'de nörorehabilitasyon hastalarının değerlendirilmesinde fonksiyonel bağımsızlık ölçeği ve Modifiye Barthel İndeksi'nin yeriLink provided by the sponsor.
- Bone mineral density and its relationship with body composition indices in stroke patientsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known whether there will be a plan to roll out IPD.
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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.
Raziye Çelik, PT. principal investigator
Pamukkale University
Emre Baskan, Assoc Prof. study director
Pamukkale University
Aziz Dengiz, PT Phd study director
Muş Alparslan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioelectrical Impedance Analysis in people with Cerebrovascular Stroke and Body Composition, run by Pamukkale 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 8 inclusion and 7 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 13 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?
Bioelectrical Impedance Analysis (time frame: 12 week). The study lists 6 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 NCT06255145, which also lists 34 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 13 Feb 2024.