NCT04084002

Brief Summary

The aim of this study was to investigate the relationships between physical activity level and demographic factors, motor function, cognitive function, functional status, balance and quality of life in patients with chronic stroke and to compare physical activity levels with healthy individuals in the same population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 6, 2019

Last Update Submit

September 15, 2019

Conditions

Stroke

Keywords

strokephysical activity

Outcome Measures

Primary Outcomes (3)

  • ACtotal

    Total activity count (AC) obtained from accelerometer

    Day 0

  • EEtotal

    Total energy expenditure (EE) obtained from accelerometer

    Day 0

  • PASE

    Physical Activity Score for Elderly (PASE)

    Day 0

Secondary Outcomes (30)

  • AC moderate

    Day 0

  • EE moderate

    Day 0

  • AC light

    Day 0

  • EE light

    Day 0

  • AC vigorous

    Day 0

  • +25 more secondary outcomes

Study Arms (2)

Patients with subacute chronic stroke

Patients with subacute chronic stroke

Other: physical activity measurement

Control group

Healthy control group age and sex matched

Other: physical activity measurement

Interventions

physical activity measurementOTHER

Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)

Control groupPatients with subacute chronic stroke

Eligibility Criteria

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

Patients with stroke and their age and sex matched controls

You may qualify if:

  • Patient group
  • 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 Control group
  • \. Being at between the ages of 40-80 and having not previously diagnosed with any neurologic disease

You may not qualify if:

  • Patient group
  • Having uncontrolled hypertension, cardiopulmonary disease
  • Presence of neglect, dementia, apraxia
  • Mini mental scale \>24 or being able to complete study outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine, Pendik Research and Education Hospital, Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Danielsson A, Meirelles C, Willen C, Sunnerhagen KS. Physical activity in community-dwelling stroke survivors and a healthy population is not explained by motor function only. PM R. 2014 Feb;6(2):139-45. doi: 10.1016/j.pmrj.2013.08.593. Epub 2013 Aug 23.

    PMID: 23978463RESULT

  • Lacroix J, Daviet JC, Borel B, Kammoun B, Salle JY, Mandigout S. Physical Activity Level Among Stroke Patients Hospitalized in a Rehabilitation Unit. PM R. 2016 Feb;8(2):97-104. doi: 10.1016/j.pmrj.2015.06.011. Epub 2015 Jun 21.

    PMID: 26107540RESULT

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Evrim Karadag Saygi, Prof

    Marmara University

    STUDY CHAIR

Central Study Contacts

Esra Giray, MD

CONTACT

+905558134394girayesra@hotmail.com

Evrim Karadag Saygi, Prof

CONTACT

+905558134394evrimkaradag4@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

September 16, 2019

Primary Completion

November 15, 2019

Study Completion

November 16, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

TU(1)