StrokeNCT04092322
Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients
An observational study of Stroke, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The Physical Activity Scale for the Elderly (PASE) is a self-report questionnaire on exercise, home, and work-related physical activities performed during the last week. PASE has shown to be reliable and valid in different populations of people between 65 and 100 years of age and after stroke. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Actical accelerometers (Philips Respironics) and PASE
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2019to 25 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke between the ages of 40-80 who can walk independently or with an assistive device
Who may be able to join
- 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
Who cannot join
- Illiteracy
- Having severely impaired mental function and being unable to complete questionnaires
- Presence of neglect, demantia, apraxia
- Having uncontrolled hypertension, cardiopulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients: Relationship Between PASE and Physical Activity Measured by Portable Accelerometer
The Physical Activity Scale for the Elderly (PASE) is a self-report questionnaire on exercise, home, and work-related physical activities performed during the last week. PASE has shown to be reliable and valid in different populations of people between 65 and 100 years of age and after stroke. However, its validation on stroke was based on another self report questionnaire that assess physical activity called ''Senior Fitness Test''. Since accelerometers are more objective methods to assess PA, to the best of our knowledge, self-report physical activity questionnaires should be validated based on accelerometer derived physical activity data. The aim of this study is to validate PASE in patients with stroke based on accelerometer data.
Read the detailed description
The Physical Activity Scale for the Elderly (PASE) is a self-report questionnaire on exercise, home, and work-related physical activities performed during the last week. PASE has shown to be reliable and valid in different populations of people between 65 and 100 years of age and after stroke. However, its validation on stroke was based on another self report questionnaire that assess physical activity (PA) called ''Senior Fitness Test''. There are four methods to measure physical activity: 1. Self-Report Questionnaires 2.Self-Report Activity Diaries/Logs 3.Direct Observation 4. Devices (Accelerometers, pedometers, arm band, Heart-Rate Monitors). Accelerometers can measure PA accurately and have ability capture large amounts of data. Accelerometers measure acceleration (activity counts:AC) in real time and detect movement in up to three orthogonal planes (anteroposterior, mediolateral, and vertical) These counts are then translated into a metric of interest, which can be biological (e.g. energy expenditure) or PA patterns (e.g. stationary). There are pros and cons of measurement methods of physical activity. Strengths of accelerometers include minute-by-minute on-line monitoring, capturing intensity level. Accumulated AC provide an accurate estimate of the duration and intensity of body movement at the waist and were summed across the whole day to assess total PA volume. However, accelerometers are expensive and require technical expertise, specialized hardware, software, and individual programming. Self-report PA measurement methods are able to measure large numbers of participants at low cost. Since accelerometers are more objective methods to assess PA, to the best of our knowledge, self-report physical activity questionnaires should be validated based on accelerometer derived physical activity data. The aim of this study is to validate PASE in patients with stroke based on accelerometer data.
- Conditions
- Stroke
- Being tested
- Actical accelerometers (Philips Respironics), PASE
- Keywords
- stroke, physical activity, accelerometer, physical activity scale for elderly
- 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.
Actical accelerometers (Philips Respironics)Device
patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday
PASEOther
Physical Activity Scale for Elderly
| Study group | Role | What they receive |
|---|---|---|
| Patients with subacute chronic stroke | Patients with subacute chronic stroke between the ages of 40-80 Receives: Device: Actical accelerometers (Philips Respironics); Other: PASE |
What is being measured
The primary outcome is the main question the study is designed to answer.
PASE
Physical Activity Score for Elderly
Measured: Day 0
Secondary outcomes (12)
ACtotal
Total activity count obtained from accelerometer
Measured: Day 0
EE total
Total energy expenditure obtained from accelerometer
Measured: Day 0
AC moderate
activity counts derived from accelerometer during moderate physical activity
Measured: Day 0
EE moderate
energy expenditure obtained from accelerometer during moderate physical activity
Measured: Day 0
AC light
activity counts derived from accelerometer during light physical activity
Measured: Day 0
EE light
energy expenditure obtained from accelerometer during light physical activity
Measured: Day 0
AC vigorous
activity counts derived from accelerometer during vigorous physical activity
Measured: Day 0
EE vigorous
energy expenditure obtained from accelerometer during vigorous physical activity
Measured: Day 0
AC sedentary
activity counts derived from accelerometer during sedentary physical activity
Measured: Day 0
EE sedentary
energy expenditure obtained from accelerometer during sedentary physical activity
Measured: Day 0
step count
total step count obtained from accelerometer
Measured: Day 0
Stroke Impact Scale total score
Stroke Impact Scale is a stroke specific quality of life scale. The current version of the SIS (SIS version 3.0) is a 59-item patient-reported outcome measure, covering 8 domains: strength (4 items), hand function (5 items), mobility (9 items), activities of daily living (10 items), memory (7 items), communication (7 items), emotion (9 items), and handicap (8 items). Domains are scored on a metric of 0 to 100, with higher scores indicating better self-reported health. Four of the scales of the SIS can be combined into a composite physical domain (strength, hand function, physical and instrumental activities of daily living, and mobility), with scores also presented on a 0 to 100 metric.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start25 Sep 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evrim Karadag Saygi, Prof, Study chair, Marmara UniversityEsra Giray, MD, Principal investigator, Marmara UniversityNurullah Eren, PT, Principal investigator, Marmara University School of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092322
- Sponsor's protocol ID
- 09.2019.205
- Status last verified
- Sep 2019
- First submitted
- 15 Sep 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marianne Lindahl, Lotte Hansen, Anders Pedersen, Thomas Truelsen & Gudrun Boysen (2008) Self-reported physical activity after ischemic stroke correlates with physical capacity, Advances in Physiotherapy, 10:4, 188-194, DOI: 10.1080/14038190802490025
Hills AP, Mokhtar N, Byrne NM. Assessment of physical activity and energy expenditure: an overview of objective measures. Front Nutr. 2014 Jun 16;1:5. doi: 10.3389/fnut.2014.00005. eCollection 2014.
PubMed 25988109Persson CU, Hansson PO, Lappas G, Danielsson A. Physical Activity Levels and Their Associations With Postural Control in the First Year After Stroke. Phys Ther. 2016 Sep;96(9):1389-96. doi: 10.2522/ptj.20150367. Epub 2016 Mar 24.
PubMed 27013578Sylvia LG, Bernstein EE, Hubbard JL, Keating L, Anderson EJ. Practical guide to measuring physical activity. J Acad Nutr Diet. 2014 Feb;114(2):199-208. doi: 10.1016/j.jand.2013.09.018. Epub 2013 Nov 28. No abstract available.
PubMed 24290836
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients: Relationship Between PASE and Physical Activity Measured by Portable Accelerometer
- ClinicalTrials.gov ID
- NCT04092322
- Acronym / sponsor ID
- 09.2019.205
- Conditions
- Stroke
- Keywords
- stroke, physical activity, accelerometer, physical activity scale for elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 17 Sep 2019 (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 Physical Activity Scale for the Elderly (PASE) is a self-report questionnaire on exercise, home, and work-related physical activities performed during the last week. PASE has shown to be reliable and valid in different populations of people between 65 and 100 years of age and after stroke. However, its validation on stroke was based on another self report questionnaire that assess physical activity called ''Senior Fitness Test''. Since accelerometers are more objective methods to assess PA, to the best of our knowledge, self-report physical activity questionnaires should be validated based on accelerometer derived physical activity data. The aim of this study is to validate PASE in patients with stroke based on accelerometer data.
Detailed description
The Physical Activity Scale for the Elderly (PASE) is a self-report questionnaire on exercise, home, and work-related physical activities performed during the last week. PASE has shown to be reliable and valid in different populations of people between 65 and 100 years of age and after stroke. However, its validation on stroke was based on another self report questionnaire that assess physical activity (PA) called ''Senior Fitness Test''. There are four methods to measure physical activity: 1. Self-Report Questionnaires 2.Self-Report Activity Diaries/Logs 3.Direct Observation 4. Devices (Accelerometers, pedometers, arm band, Heart-Rate Monitors). Accelerometers can measure PA accurately and have ability capture large amounts of data. Accelerometers measure acceleration (activity counts:AC) in real time and detect movement in up to three orthogonal planes (anteroposterior, mediolateral, and vertical) These counts are then translated into a metric of interest, which can be biological (e.g. energy expenditure) or PA patterns (e.g. stationary). There are pros and cons of measurement methods of physical activity. Strengths of accelerometers include minute-by-minute on-line monitoring, capturing intensity level. Accumulated AC provide an accurate estimate of the duration and intensity of body movement at the waist and were summed across the whole day to assess total PA volume. However, accelerometers are expensive and require technical expertise, specialized hardware, software, and individual programming. Self-report PA measurement methods are able to measure large numbers of participants at low cost. Since accelerometers are more objective methods to assess PA, to the best of our knowledge, self-report physical activity questionnaires should be validated based on accelerometer derived physical activity data. The aim of this study is to validate PASE in patients with stroke based on accelerometer data.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with subacute chronic stroke | – | Device: Actical accelerometers (Philips Respironics), Other: PASEPatients with subacute chronic stroke between the ages of 40-80 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke between the ages of 40-80 who can walk independently or with an assistive device
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Illiteracy
- Having severely impaired mental function and being unable to complete questionnaires
- Presence of neglect, demantia, apraxia
- Having uncontrolled hypertension, cardiopulmonary disease
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 |
|---|---|---|
| Actical accelerometers (Philips Respironics)patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday | Device | Patients with subacute chronic stroke |
| PASEPhysical Activity Scale for Elderly | Other | Patients with subacute chronic stroke |
Primary outcome
PASE
Time frame: Day 0
Physical Activity Score for Elderly
12 secondary outcomes
ACtotal
Time frame: Day 0
EE total
Time frame: Day 0
AC moderate
Time frame: Day 0
EE moderate
Time frame: Day 0
AC light
Time frame: Day 0
EE light
Time frame: Day 0
AC vigorous
Time frame: Day 0
EE vigorous
Time frame: Day 0
AC sedentary
Time frame: Day 0
EE sedentary
Time frame: Day 0
step count
Time frame: Day 0
Stroke Impact Scale total score
Time frame: Day 0
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 26 Nov 2019.
- BackgroundMarianne Lindahl, Lotte Hansen, Anders Pedersen, Thomas Truelsen & Gudrun Boysen (2008) Self-reported physical activity after ischemic stroke correlates with physical capacity, Advances in Physiotherapy, 10:4, 188-194, DOI: 10.1080/14038190802490025
- Results publication: PubMed 25988109Hills AP, Mokhtar N, Byrne NM. Assessment of physical activity and energy expenditure: an overview of objective measures. Front Nutr. 2014 Jun 16;1:5. doi: 10.3389/fnut.2014.00005. eCollection 2014.
- Results publication: PubMed 27013578Persson CU, Hansson PO, Lappas G, Danielsson A. Physical Activity Levels and Their Associations With Postural Control in the First Year After Stroke. Phys Ther. 2016 Sep;96(9):1389-96. doi: 10.2522/ptj.20150367. Epub 2016 Mar 24.
- Results publication: PubMed 24290836Sylvia LG, Bernstein EE, Hubbard JL, Keating L, Anderson EJ. Practical guide to measuring physical activity. J Acad Nutr Diet. 2014 Feb;114(2):199-208. doi: 10.1016/j.jand.2013.09.018. Epub 2013 Nov 28. No abstract available.
- Individual participant dataSharing planned: No
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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.
Evrim Karadag Saygi, Prof study chair
Marmara University
Esra Giray, MD principal investigator
Marmara University
Nurullah Eren, PT principal investigator
Marmara University School of Health Sciences
1 site in 1 country: see every site and its status.
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 3 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: finished, as of the sponsor's last update on 26 Nov 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?
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?
PASE (time frame: Day 0). 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 NCT04092322, which also lists 4 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 26 Nov 2019.