- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092322
Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients
November 25, 2019 updated by: Marmara University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
25
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
-
-
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Istanbul, Turkey, 34899
- Esra Giray
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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
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with stroke between the ages of 40-80 who can walk independently or with an assistive device
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Illiteracy
- Having severely impaired mental function and being unable to complete questionnaires
- Presence of neglect, demantia, apraxia
- Having uncontrolled hypertension, cardiopulmonary disease
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
Patients with subacute chronic stroke between the ages of 40-80
|
patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday
Physical Activity Scale for Elderly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PASE
Time Frame: Day 0
|
Physical Activity Score for Elderly
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ACtotal
Time Frame: Day 0
|
Total activity count obtained from accelerometer
|
Day 0
|
|
EE total
Time Frame: Day 0
|
Total energy expenditure obtained from accelerometer
|
Day 0
|
|
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 total score
Time Frame: Day 0
|
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.
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nurullah Eren, PT, Marmara University School of Health Sciences
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.
General 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.
- Persson 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.
- Sylvia 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.
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 25, 2019
Primary Completion (ACTUAL)
November 25, 2019
Study Completion (ACTUAL)
November 25, 2019
Study Registration Dates
First Submitted
September 15, 2019
First Submitted That Met QC Criteria
September 15, 2019
First Posted (ACTUAL)
September 17, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 26, 2019
Last Update Submitted That Met QC Criteria
November 25, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2019.205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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