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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04092322
• Other study ID #: 09.2019.205
• Status: Completed
• Start date: September 25, 2019
• Est. completion date: November 25, 2019

Study information

• Verified date: September 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 25, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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

Other:
• PASE
Physical Activity Scale for Elderly

Locations

Country	Name	City	State
Turkey	Esra Giray	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View 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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PASE	Physical Activity Score for Elderly	Day 0
Secondary	ACtotal	Total activity count obtained from accelerometer	Day 0
Secondary	EE total	Total energy expenditure obtained from accelerometer	Day 0
Secondary	AC moderate	activity counts derived from accelerometer during moderate physical activity	Day 0
Secondary	EE moderate	energy expenditure obtained from accelerometer during moderate physical activity	Day 0
Secondary	AC light	activity counts derived from accelerometer during light physical activity	Day 0
Secondary	EE light	energy expenditure obtained from accelerometer during light physical activity	Day 0
Secondary	AC vigorous	activity counts derived from accelerometer during vigorous physical activity	Day 0
Secondary	EE vigorous	energy expenditure obtained from accelerometer during vigorous physical activity	Day 0
Secondary	AC sedentary	activity counts derived from accelerometer during sedentary physical activity	Day 0
Secondary	EE sedentary	energy expenditure obtained from accelerometer during sedentary physical activity	Day 0
Secondary	step count	total step count obtained from accelerometer	Day 0
Secondary	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.	Day 0

External Links

•   PASE Physical Activity Scale for the Elderly Administration and Scoring Instruction Manual