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Completed

NCT Number: NCT04092322

Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Esra Giray

Istanbul, 34899, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

PASE

Other

Physical Activity Scale for Elderly

Primary outcomes

  1. PASE

    Time frame: Day 0

    Physical Activity Score for Elderly

Secondary outcomes

  1. ACtotal

    Time frame: Day 0

    Total activity count obtained from accelerometer

  2. EE total

    Time frame: Day 0

    Total energy expenditure obtained from accelerometer

  3. AC moderate

    Time frame: Day 0

    activity counts derived from accelerometer during moderate physical activity

  4. EE moderate

    Time frame: Day 0

    energy expenditure obtained from accelerometer during moderate physical activity

  5. AC light

    Time frame: Day 0

    activity counts derived from accelerometer during light physical activity

  6. EE light

    Time frame: Day 0

    energy expenditure obtained from accelerometer during light physical activity

  7. AC vigorous

    Time frame: Day 0

    activity counts derived from accelerometer during vigorous physical activity

  8. EE vigorous

    Time frame: Day 0

    energy expenditure obtained from accelerometer during vigorous physical activity

  9. AC sedentary

    Time frame: Day 0

    activity counts derived from accelerometer during sedentary physical activity

  10. EE sedentary

    Time frame: Day 0

    energy expenditure obtained from accelerometer during sedentary physical activity

  11. step count

    Time frame: Day 0

    total step count obtained from accelerometer

  12. 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients: Relationship Between PASE and Physical Activity Measured by Portable Accelerometer

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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