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

Sponsor
Izmir Democracy University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06008444
Collaborator
(none)
32
15

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physical Evaluations of post-COVID-19 individuals
  • Other: Physical Evaluations of non-post-COVID-19 individuals

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
32 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Chest Mobility, Cough Strength, Muscle Strength, Physical Activity and Quality of Life in Parkinson's Patients Who Have Had COVID-19
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Total quality of life score evaluated by Parkinson's Disease Questionnaire (PDQ-39) questionnaire. [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.

Secondary Outcome Measures

  1. Cough Strength [through study completion, an average of 1 year]

    Cough Strength will be evaluated using a Peak Flow Meter.

  2. Daily average step count [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.

  3. Hand grip strength [through study completion, an average of 1 year]

    Hand grip strength will be evaluated using a hand dynamometer.

  4. Chest mobility [through study completion, an average of 1 year]

    Chest mobility will be evaluated using a tape measure.

  5. Cognitive status [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
gulsahbargi, Principal Investigator, Izmir Democracy University
ClinicalTrials.gov Identifier:
NCT06008444
Other Study ID Numbers:
  • Effects of COVID on Parkinson
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by gulsahbargi, Principal Investigator, Izmir Democracy University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023