NCT07000331

Brief Summary

The effects of breathing exercises and physical activity counseling applied for 4 weeks on the number of daily steps, dyspnea, pain, fatigue, mood and quality of life in individuals who have just had COVID-19 are not yet known. For this reason, it was aimed to investigate in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2023

Longer than P75 for not_applicable covid19

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

Study Start

First participant enrolled

February 16, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 2, 2025

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

May 30, 2025

Last Update Submit

June 1, 2025

Conditions

Keywords

physical activitydyspneapainfatigueanxietydepressionquality of life

Outcome Measures

Primary Outcomes (1)

  • Daily step counts

    Daily average step counts were recorded via a pedometer.

    Baseline, at the end of everyday during 4-week and at 4 weeks after baseline evaluation

Secondary Outcomes (6)

  • Anxiety score

    Baseline and at 4 weeks after baseline evaluation

  • Depression score

    Baseline and at 4 weeks after baseline evaluation

  • Dyspnea score

    Baseline and at 4 weeks after baseline evaluation

  • Pain score

    Baseline and at 4 weeks after baseline evaluation

  • Fatigue score

    Baseline and at 4 weeks after baseline evaluation

  • +1 more secondary outcomes

Study Arms (2)

Study group

EXPERIMENTAL

The individuals in the study group were given thoracic expansion exercises and physical activity counseling.

Other: Thoracic expansion exercisesOther: Physical activity counseling

Control group

NO INTERVENTION

Individuals in this group continued their normal daily living activities and were followed up only with follow-up.

Interventions

Individuals placed their hands on their lower ribs and then took 3 deep breaths under their hands in a row. After this cycle, individuals rested by taking 3-4 calm breaths. The cycle was repeated 10 times. The individual did this session 4 times a day.

Study group

Individuals were given weekly group phone calls and meetings. Individuals were gradually accustomed to regular walking to increase their daily step count. In the first week, individuals were asked to walk a total of 30-45 minutes per day, at least 4-5 days per week, and to increase the number of steps measured at the beginning by approximately 1000-2000 steps per day to reach at least 6500 steps. In the second week, the expected goal was at least 7500 steps. In the third and fourth weeks, they were asked to reach at least 10000 steps.

Study group

Eligibility Criteria

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

You may qualify if:

  • Adult individuals aged 18 and over who volunteered to participate in the research
  • Individuals who can understand and answer surveys
  • Compatible individuals who can perform exercises and have good cooperation.
  • Individuals who were diagnosed with COVID-19 (individuals with a positive Polymerase Chain Reaction (PCR) test result, compatible with COVID-19 infection as a result of lung X-ray or lung tomography despite negative PCR test results) and discharged after recovery/home quarantine completed

You may not qualify if:

  • Individuals newly diagnosed with COVID-19, therefore in quarantine at home or receiving treatment in hospital
  • Individuals with suspected COVID-19
  • Pregnant women
  • Individuals with serious psychiatric illness and therefore unable to adapt to exercise sessions
  • Individuals with severe cognitive impairment
  • Individuals with ongoing orthopedic, neurological, cardiovascular disorders and/or problems which are independent of COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (2)

  • Wang TJ, Chau B, Lui M, Lam GT, Lin N, Humbert S. Physical Medicine and Rehabilitation and Pulmonary Rehabilitation for COVID-19. Am J Phys Med Rehabil. 2020 Sep;99(9):769-774. doi: 10.1097/PHM.0000000000001505.

    PMID: 32541352BACKGROUND
  • Amini H, Isanejad A, Chamani N, Movahedi-Fard F, Salimi F, Moezi M, Habibi S. Physical activity during COVID-19 pandemic in the Iranian population: A brief report. Heliyon. 2020 Nov;6(11):e05411. doi: 10.1016/j.heliyon.2020.e05411. Epub 2020 Nov 2.

    PMID: 33163638BACKGROUND

MeSH Terms

Conditions

COVID-19Motor ActivityDyspneaPainFatigueAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehaviorRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsMental DisordersBehavioral Symptoms

Study Officials

  • GÜLŞAH BARĞI, Assoc. Dr.

    Izmir Democracy University

    STUDY DIRECTOR
  • SENA UYGUNLAR

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • GÜLCAN POLAT

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • DİLAN SU AKTAŞ

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR
  • UĞUR CANBULAT

    Izmir Democracy University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind study; the participants were not informed about whether they were in the study group or control group.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 2, 2025

Study Start

February 16, 2023

Primary Completion

August 30, 2024

Study Completion

December 30, 2024

Last Updated

June 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations