NCT05572827

Brief Summary

The purpose of this study is to evaluate the effectiveness of teaching breathing exercises to COVID-19 patients after intensive care.The research is a randomized controlled and pretest-posttest applied design. The population of the research will consist of patients who have been previously admitted to the intensive care unit of the hospital where the research will be conducted and who meet the research criteria.The data of the study are "Patient Information Form" and "Data Registration Form", "Care dependency scale", "Health Screening short form-36", "Saint George Respiratory Questionnaire (SGRQ), "Respiratory Function Test", "Respiratory Exercises Information Booklet" and "Breathing Exercises Information Booklet".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

September 15, 2022

Last Update Submit

January 6, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • Data Registration Form.

    It is the form in which the systolic blood pressure, diastolic blood pressure, pulse, respiration, body temperature, oxygen saturation values taken twice a day, before and after exercise, are recorded.

    3 months

  • Patient Identification Form.

    Patients have name-surname, age, gender, height, weight, educational status, occupation, marital status, clinical data (history, family history, medications used, use of assistive devices, smoking history, respiratory system evaluation) and exercise habits.

    3 months

  • Baseline dyspnea scale

    Mahler et al. It was developed by 1984. The validity and reliability of the Basal Dyspnea Scale in our country have been made by different researchers, and the scale evaluates dyspnea due to activity; It measures in three different areas: functional status (level of performing activities of daily living), effort capacity (difficult efforts to perform activities) and work capacity.

    3 months

  • Health Screening short form-36 Short Form-36

    (Short Form-36 Health Survey - SF-36) will be used to assess overall health-related quality of life. SF-36 is a self-rating scale. Subscales evaluate health on a scale of 0-100, with 0 indicating poor health and 100 indicating good health.

    3 months

  • Saint George Respiratory Questionnaire (SGRQ)

    The Saint George Respiratory Questionnaire (SGRQ) will be used to assess the disease-specific quality of life. The SGRQ is a questionnaire in which patients self-answer questions. The questionnaire, which consists of three categories, questions the effects of symptoms, activity and illness on daily life. It is considered to be more standardized than other health-related quality of life questionnaires. It is mostly used in COPD, asthma and bronchiectasis. It has an evaluation scale between 0-100 points in the questionnaire consisting of a total of 76 questions. Zero indicates best health and 100 indicates worst health.

    3 months

  • Pulmonary Function Test

    Pulmonary function tests are an objective method used in the diagnosis and follow-up of the disease. In pulmonary function tests, the percentages of forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), the ratio of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC), peak flow rate (PEF), values to the expected value will be recorded.

    3 months

  • Care dependency scale.

    In the study, this scale was used to determine the care dependency of the patients. The lowest score obtained from the scale is 17 and the highest score is 85. A high scale score indicates that the individual is independent in meeting their care needs, while a low scale score indicates that the individual is dependent on meeting their care needs.

    3 months

Study Arms (2)

Experimental

EXPERIMENTAL

Breathing exercises will be taught to COVID-19 patients after intensive care.

Behavioral: Breathing exercises

Control

NO INTERVENTION

Breathing exercises will not be taught to COVID-19 patients after intensive care.

Interventions

Breathing exercises for COVID-19 patients after intensive care increase their quality of life.

Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a patient who was treated in the intensive care unit and referred to the clinic due to Covid-19 PCR positivity
  • Ability to do exercises appropriately
  • Absence of any communication or medically defined mental problems
  • Being able to understand and speak Turkish
  • Not having any disease that may be risky for the study (uncontrolled diabetes, malignant hypertension, thyrotoxicosis, orthopedic defect, muscle and joint disease)
  • Volunteering to participate in the study

You may not qualify if:

  • Not being treated in the intensive care unit due to Covid-19 PCR positivity
  • Having any communication or medically defined mental problems
  • Inability to properly perform exercises prepared for study
  • Those with an uncontrollable additional disease (diabetes, thyrotoxicosis, malignant hypertension)
  • Those who cannot understand and speak Turkish
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University Faculty of Nursing

Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Bahar Çiftçi

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2022

First Posted

October 10, 2022

Study Start

August 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations