Clinical trial NCT04084002: Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke
Official title: Evaluation of Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke
physical activity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stroke and their age and sex matched controls

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

Patient group

1. Patients with first ever, unilateral stroke
2. Patients with stroke who can walk independently or with an assistive device
3. 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

Exclusion Criteria:

Patient group

1. Having uncontrolled hypertension, cardiopulmonary disease
2. Presence of neglect, dementia, apraxia
3. Mini mental scale \>24 or being able to complete study outcomes

Primary outcomes:
measure: ACtotal
timeFrame: Day 0
measure: EEtotal
timeFrame: Day 0
measure: PASE
timeFrame: Day 0
Secondary outcomes:
measure: AC moderate
timeFrame: Day 0
measure: EE moderate
timeFrame: Day 0
measure: AC light
timeFrame: Day 0
measure: EE light
timeFrame: Day 0
measure: AC vigorous
timeFrame: Day 0
measure: EE vigorous
timeFrame: Day 0
measure: AC sedentary
timeFrame: Day 0
measure: EE sedentary
timeFrame: Day 0
measure: step count
timeFrame: Day 0
measure: Stroke Impact Scale
timeFrame: Day 0
measure: Berg Balance Score
timeFrame: Day 0
measure: Barthel Index for Activities of Daily Living
timeFrame: Day 0
measure: FMA-UE
timeFrame: Day 0
measure: FMA-LE
timeFrame: Day 0
measure: FMA-total
timeFrame: Day 0
measure: Brunnstrom stage for proximal upper extremity
timeFrame: Day 0
measure: Brunnstrom stage for distal upper extremity
timeFrame: Day 0
measure: Brunnstrom stage for lower extremity
timeFrame: Day 0
measure: FAS stage
timeFrame: Day 0
measure: Mini Mental Test
timeFrame: Day 0
measure: stroke duration
timeFrame: Day 0
measure: WA step width
timeFrame: Day 0
measure: WA step length
timeFrame: Day 0
measure: WA walking speed
timeFrame: Day 0
measure: Modified Clinical Test of Sensory Interaction on Balance
timeFrame: Day 0
measure: LOS RT
timeFrame: Day 0
measure: LOS VL
timeFrame: Day 0
measure: LOS EPE
timeFrame: Day 0
measure: LOS MXE
timeFrame: Day 0
measure: LOS DCL
timeFrame: Day 0
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Marmara University
name: Evrim Karadag Saygi, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: Lacroix 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.