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

September 15, 2019 updated by: Marmara University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation
        • Contact:
          • Naime Evrim Karadag Saygi, Prof
          • Phone Number: 1628 00902166570606
        • Contact:
          • Esra G Giray, MD
          • Phone Number: 1628 00902166570606
        • Principal Investigator:
          • Nurullah Eren, PT
        • Principal Investigator:
          • Esra Giray, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with stroke and their age and sex matched controls

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with subacute chronic stroke
Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)
Control group
Healthy control group age and sex matched
Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACtotal
Time Frame: Day 0
Total activity count (AC) obtained from accelerometer
Day 0
EEtotal
Time Frame: Day 0
Total energy expenditure (EE) obtained from accelerometer
Day 0
PASE
Time Frame: Day 0
Physical Activity Score for Elderly (PASE)
Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2019

Primary Completion (Anticipated)

November 15, 2019

Study Completion (Anticipated)

November 16, 2019

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 15, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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