Clinical trial NCT04092322: Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients
Official title: Validation of Physical Activity Scale for the Elderly (PASE) in Stroke Patients: Relationship Between PASE and Physical Activity Measured by Portable Accelerometer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: stroke
physical activity
accelerometer
physical activity scale for elderly
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stroke between the ages of 40-80 who can walk independently or with an assistive device

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: PASE
timeFrame: Day 0
Secondary outcomes:
measure: ACtotal
timeFrame: Day 0
measure: EE total
timeFrame: Day 0
measure: AC moderate
timeFrame: Day 0
measure: EE moderate
timeFrame: Day 0
measure: AC light
timeFrame: Day 0
measure: EE light
timeFrame: Day 0
measure: AC vigorous
timeFrame: Day 0
measure: EE vigorous
timeFrame: Day 0
measure: AC sedentary
timeFrame: Day 0
measure: EE sedentary
timeFrame: Day 0
measure: step count
timeFrame: Day 0
measure: Stroke Impact Scale total score
timeFrame: Day 0
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Esra Giray
Study officials:
affiliation: Marmara University
name: Evrim Karadag Saygi, Prof
role: STUDY_CHAIR
affiliation: Marmara University
name: Esra Giray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University School of Health Sciences
name: Nurullah Eren, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.