NCT04092322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

November 26, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 15, 2019

Last Update Submit

November 25, 2019

Conditions

Stroke

Keywords

strokephysical activityaccelerometerphysical activity scale for elderly

Outcome Measures

Primary Outcomes (1)

  • PASE

    Physical Activity Score for Elderly

    Day 0

Secondary Outcomes (12)

  • ACtotal

    Day 0

  • EE total

    Day 0

  • AC moderate

    Day 0

  • EE moderate

    Day 0

  • AC light

    Day 0

  • +7 more secondary outcomes

Study Arms (1)

Patients with subacute chronic stroke

Patients with subacute chronic stroke between the ages of 40-80

Device: Actical accelerometers (Philips Respironics)Other: PASE

Interventions

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

Patients with subacute chronic stroke
PASEOTHER

Physical Activity Scale for Elderly

Patients with subacute chronic stroke

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with stroke between the ages of 40-80 who can walk independently or with an assistive device

You may qualify if:

  • 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

You may not qualify if:

  • Illiteracy
  • Having severely impaired mental function and being unable to complete questionnaires
  • Presence of neglect, demantia, apraxia
  • Having uncontrolled hypertension, cardiopulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Giray

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (4)

  • 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

    BACKGROUND

  • 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.

    PMID: 25988109RESULT

  • 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.

    PMID: 27013578RESULT

  • 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.

    PMID: 24290836RESULT

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Evrim Karadag Saygi, Prof

    Marmara University

    STUDY CHAIR

  • Esra Giray, MD

    Marmara University

    PRINCIPAL INVESTIGATOR

  • Nurullah Eren, PT

    Marmara University School of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 17, 2019

Study Start

September 25, 2019

Primary Completion

November 25, 2019

Study Completion

November 25, 2019

Last Updated

November 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)