Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke

Stroke Clinical Trial

Official title:

Evaluation of Physical Activity and Related Factors in a Sample of Turkish Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04084002
• Other study ID #: 17.12.2018-242
• Status: Recruiting
• Start date: September 16, 2019
• Est. completion date: November 16, 2019

Study information

• Verified date: September 2019
• Source: Marmara University
• Contact: Esra Giray, MD
• Phone: +905558134394
• Email: girayesra[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 16, 2019
• Est. primary completion date: November 15, 2019
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• physical activity measurement
Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACtotal	Total activity count (AC) obtained from accelerometer	Day 0
Primary	EEtotal	Total energy expenditure (EE) obtained from accelerometer	Day 0
Primary	PASE	Physical Activity Score for Elderly (PASE)	Day 0
Secondary	AC moderate	activity counts derived from accelerometer during moderate physical activity	Day 0
Secondary	EE moderate	energy expenditure obtained from accelerometer during moderate physical activity	Day 0
Secondary	AC light	activity counts derived from accelerometer during light physical activity	Day 0
Secondary	EE light	energy expenditure obtained from accelerometer during light physical activity	Day 0
Secondary	AC vigorous	activity counts derived from accelerometer during vigorous physical activity	Day 0
Secondary	EE vigorous	energy expenditure obtained from accelerometer during vigorous physical activity	Day 0
Secondary	AC sedentary	activity counts derived from accelerometer during sedentary physical activity	Day 0
Secondary	EE sedentary	energy expenditure obtained from accelerometer during sedentary physical activity	Day 0
Secondary	step count	total step count obtained from accelerometer	Day 0
Secondary	Stroke Impact Scale	Stroke Impact Scale	Day 0
Secondary	Berg Balance Score	Berg Balance Score	Day 0
Secondary	Barthel Index for Activities of Daily Living	Barthel Index for Activities of Daily Living	Day 0
Secondary	FMA-UE	The Fugl-Meyer Assessment for upper extremity	Day 0
Secondary	FMA-LE	The Fugl-Meyer Assessment for lower extremity	Day 0
Secondary	FMA-total	The Fugl-Meyer Assessment total score	Day 0
Secondary	Brunnstrom stage for proximal upper extremity	Brunnstrom stage for proximal upper extremity	Day 0
Secondary	Brunnstrom stage for distal upper extremity	Brunnstrom stage for distal upper extremity	Day 0
Secondary	Brunnstrom stage for lower extremity	Brunnstrom stage for lower extremity	Day 0
Secondary	FAS stage	Functional Ambulation Scale (FAS) stage	Day 0
Secondary	Mini Mental Test	Mini Mental Test	Day 0
Secondary	stroke duration	stroke duration	Day 0
Secondary	WA step width	Walk Across step width obtained from Neurocom forceplate	Day 0
Secondary	WA step length	Walk Across step width obtained from Neurocom forceplate	Day 0
Secondary	WA walking speed	Walk Across walking speed obtained from Neurocom forceplate	Day 0
Secondary	Modified Clinical Test of Sensory Interaction on Balance	Modified Clinical Test of Sensory Interaction on Balance obtained from Neurocom forceplate	Day 0
Secondary	LOS RT	Limits of Stability reaction time obtained from Neurocom forceplate	Day 0
Secondary	LOS VL	Limits of Stability movement velocity obtained from Neurocom forceplate	Day 0
Secondary	LOS EPE	Limits of Stability endpoint excursion obtained from Neurocom forceplate	Day 0
Secondary	LOS MXE	Limits of Stability maximum excursion obtained from Neurocom forceplate	Day 0
Secondary	LOS DCL	Limits of Stability directional control obtained from Neurocom forceplate	Day 0