Chest Mobility, Strength, Physical Activity and Quality of Life in Parkinson's Patients With Post-COVID-19

December 18, 2023 updated by: Gulsah Bargi, Izmir Democracy University

Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19

To comparative pain intensity, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients with post-COVID-19 and without post-COVID-19 was aimed in current study. Knowledge in the literature regarding this topic is still obscure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute worsening and long-term sequelae of motor and non-motor symptoms have also been described in Parkinson's patients during and after SARS-CoV-2 infection, which is also known as prolonged COVID. The effects of COVID-19 on pain, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients are still unclear today. For this reason, in this study, it was aimed to comparatively investigate pain, chest mobility, cough strength, muscle strength, physical activity levels and quality of life in Parkinson's patients with COVID-19 and without COVID-19 and to show the relationships between these outcome measures.

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: MERVE ŞAHİN

Study Locations

  • Turkey
      • İzmir, Turkey, 35140
        • Recruiting
        • Izmir Democracy University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

At least 21 Parkinson's patients with post-COVID-19 will be included in the main group and at least 11 Parkinson's patients without post-COVID-19 will be included in control group.

Description

Inclusion Criteria for Parkinson's patients with post-COVID-19;

  • Being diagnosed with COVID-19 at least 12 weeks ago and recovered,
  • Being over 18 years old,
  • Volunteering to participate in the research,
  • Being diagnosed with Parkinson's disease
  • Comorbid conditions (such as hypertension, diabetes) are under control
  • Being able to perceive assessments (Standardized Mini Mental Test score of 24 and above)
  • Having the ability to ambulate and walk independently
  • Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale

Inclusion criteria for Parkinson's patients without post-COVID-19;

  • Not being diagnosed or suspected of COVID-19
  • Being over 18 years old,
  • Volunteering to participate in the research,
  • Being diagnosed with Parkinson's disease
  • Having comorbid conditions (such as hypertension, diabetes) which are under control
  • Being able to perceive assessments (Standardized Mini Mental Test score of 24 and above)
  • Having the ability to ambulate and walk independently
  • Being in stage 1 - 4 according to the Modified Hoehn-Yahr Scale

Exclusion criteria for Parkinson's patients with and without post-COVID-19;

  • Sudden drug or dose change during the study period
  • A history of any acute/chronic orthopedic, cardiovascular, pulmonary, psychiatric or neuromuscular disease that may prevent measurements from being made.
  • Having had myocardial infarction and pulmonary embolism in the last 30 days,
  • Having a history of additional neurological (stroke, head trauma, peripheral nerve diseases, brain and spinal cord tumors, etc.) diseases other than Parkinson's disease
  • Having severe vision loss or vestibular dysfunction
  • Patients with blood pressure values above 140/90 and below 90/50 in blood pressure measurements made before the study, with arrhythmia on ECG, with a history of shortness of breath and/or palpitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-COVID-19 group
This group will consist of individuals with Parkinson disease who have had COVID-19.
Other: Physical Evaluations of post-COVID-19 individuals
In this research, the data of Parkinson's patients who have had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.
Control group
The control group will consist of individuals with Parkinson disease without post-COVID-19.
Other: Physical Evaluations of non-post-COVID-19 individuals
In this research, the data of Parkinson's patients who have not had COVID-19 will be collected face to face. Chest mobility, cough strength, muscle strength, physical activity and quality of life will be evaluated in all Parkinson's patients. The data to be obtained through all these evaluations will be collected from at one time and in a time lasting maximum of about 1 hour. Step count tracking with pedometer will be done for 3 days for each individual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire.
Time Frame: through study completion, an average of 1 year
The status of quality of life will be evaluated using Parkinson's Disease Questionnaire (PDQ-39) questionnaire. Parkinson's Disease Questionnaire-39 (PDQ39) is a 39-item quality of life questionnaire. Evaluation for each question item ranges from 0 (no problem) to 4 (constant problem). Low scores in total indicate an improvement in people's quality of life.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough Strength
Time Frame: through study completion, an average of 1 year
Cough Strength will be evaluated using a Peak Flow Meter.
through study completion, an average of 1 year
Daily average step count
Time Frame: through study completion, an average of 1 year
Daily average step counts will be recorded via a pedometer everyday within 3 days after confirming enrolment. All individuals will be asked to carry their pedometers with them during the day and record to their diaries.
through study completion, an average of 1 year
Hand grip strength
Time Frame: through study completion, an average of 1 year
Hand grip strength will be evaluated using a hand dynamometer.
through study completion, an average of 1 year
Chest mobility
Time Frame: through study completion, an average of 1 year
Chest mobility will be evaluated using a tape measure.
through study completion, an average of 1 year
Cognitive status
Time Frame: through study completion, an average of 1 year
Cognitive state will be evaluated using The mini-mental state examination (MMSE). It is an 11 question test. The highest score from the test is 30 points. Scores of 23 and lower indicate cognitive dysfunction, and scores of 24 and higher indicate normal cognitive level.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Democracy University

Investigators

  • Study Director: GÜLŞAH BARĞI, Izmir Democracy University
  • Principal Investigator: MERVE ŞAHİN, Izmir Democracy University
  • Principal Investigator: ÖZLEM ÇİNAR ÖZDEMİR, Izmir Democracy University
  • Principal Investigator: YASEMİN ÜNAL, Bandirma Health Practice and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effects of COVID on Parkinson

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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