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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Evrim Karadag Saygi, Prof contact

+905558134394

evrimkaradag4@hotmail.com

Turkey (Türkiye)1 site, 1 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

    Recruiting

Other trials in Turkey (Türkiye)

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 groups in NCT04084002
Study groupRoleWhat they receive
Patients with subacute chronic strokePatients with subacute chronic stroke
Receives: Other: physical activity measurement
Control groupHealthy 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.

  1. ACtotal

    Total activity count (AC) obtained from accelerometer

    Measured: Day 0

  2. EEtotal

    Total energy expenditure (EE) obtained from accelerometer

    Measured: Day 0

  3. PASE

    Physical Activity Score for Elderly (PASE)

    Measured: Day 0

Secondary outcomes (30)
  1. AC moderate

    activity counts derived from accelerometer during moderate physical activity

    Measured: Day 0

  2. EE moderate

    energy expenditure obtained from accelerometer during moderate physical activity

    Measured: Day 0

  3. AC light

    activity counts derived from accelerometer during light physical activity

    Measured: Day 0

  4. EE light

    energy expenditure obtained from accelerometer during light physical activity

    Measured: Day 0

  5. AC vigorous

    activity counts derived from accelerometer during vigorous physical activity

    Measured: Day 0

  6. EE vigorous

    energy expenditure obtained from accelerometer during vigorous physical activity

    Measured: Day 0

  7. AC sedentary

    activity counts derived from accelerometer during sedentary physical activity

    Measured: Day 0

  8. EE sedentary

    energy expenditure obtained from accelerometer during sedentary physical activity

    Measured: Day 0

  9. step count

    total step count obtained from accelerometer

    Measured: Day 0

  10. Stroke Impact Scale

    Stroke Impact Scale

    Measured: Day 0

  11. Berg Balance Score

    Berg Balance Score

    Measured: Day 0

  12. Barthel Index for Activities of Daily Living

    Barthel Index for Activities of Daily Living

    Measured: Day 0

  13. FMA-UE

    The Fugl-Meyer Assessment for upper extremity

    Measured: Day 0

  14. FMA-LE

    The Fugl-Meyer Assessment for lower extremity

    Measured: Day 0

  15. FMA-total

    The Fugl-Meyer Assessment total score

    Measured: Day 0

  16. Brunnstrom stage for proximal upper extremity

    Brunnstrom stage for proximal upper extremity

    Measured: Day 0

  17. Brunnstrom stage for distal upper extremity

    Brunnstrom stage for distal upper extremity

    Measured: Day 0

  18. Brunnstrom stage for lower extremity

    Brunnstrom stage for lower extremity

    Measured: Day 0

  19. FAS stage

    Functional Ambulation Scale (FAS) stage

    Measured: Day 0

  20. Mini Mental Test

    Mini Mental Test

    Measured: Day 0

  21. stroke duration

    stroke duration

    Measured: Day 0

  22. WA step width

    Walk Across step width obtained from Neurocom forceplate

    Measured: Day 0

  23. WA step length

    Walk Across step width obtained from Neurocom forceplate

    Measured: Day 0

  24. WA walking speed

    Walk Across walking speed obtained from Neurocom forceplate

    Measured: Day 0

  25. Modified Clinical Test of Sensory Interaction on Balance

    Modified Clinical Test of Sensory Interaction on Balance obtained from Neurocom forceplate

    Measured: Day 0

  26. LOS RT

    Limits of Stability reaction time obtained from Neurocom forceplate

    Measured: Day 0

  27. LOS VL

    Limits of Stability movement velocity obtained from Neurocom forceplate

    Measured: Day 0

  28. LOS EPE

    Limits of Stability endpoint excursion obtained from Neurocom forceplate

    Measured: Day 0

  29. LOS MXE

    Limits of Stability maximum excursion obtained from Neurocom forceplate

    Measured: Day 0

  30. 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.

  1. First posted10 Sep 2019
  2. Study start16 Sep 2019
  3. Primary completion15 Nov 2019 (estimated)
  4. Study completion16 Nov 2019 (estimated)

Resources

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)
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 23978463
  • 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.

    PubMed 26107540

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.

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