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

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

      • Istanbul, Turkey, 34899
        • Esra Giray

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:

  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

Exclusion Criteria:

  1. Illiteracy
  2. Having severely impaired mental function and being unable to complete questionnaires
  3. Presence of neglect, demantia, apraxia
  4. 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.

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.

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

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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