NCT04365738

Brief Summary

The aim of this study is to investigate the efficacy of pulmonary rehabilitation(PR) applied in the isolation processes of post-acute patients with mild and moderate symptoms who had positive COVID-19 test on dyspnea,muscle pain,chest expansion,lower limb muscle strength and dynamic balance,fatigue,anxiety and depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Mar 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 26, 2020

Last Update Submit

April 26, 2020

Conditions

Keywords

Pulmonary RehabilitationDyspneaFatiguePainAnxiety

Outcome Measures

Primary Outcomes (1)

  • Dyspnea

    The Borg scale is a scale scored between 0-10, indicating the severity of dyspnea. 0 indicates no shortness of breath, 10 indicates severe shortness of breath

    Baseline, up to 4 weeks

Secondary Outcomes (4)

  • Chest expansion

    Baseline, up to 4 weeks

  • Fatigue severity

    Baseline, up to 4 weeks

  • Visual Analog Scale for pain

    Baseline, up to 4 weeks

  • Hospital anxiety and depression scale

    Baseline, up to 4 weeks

Study Arms (2)

Pulmonary Rehabilitation

EXPERIMENTAL

The patients who applied pulmonary rehabilitation were checked, motivated and followed-up regularly with video calls every day. Pulmonary rehabilitation program consists of patient education, breathing, in-house mobilization and range of motion exercises.

Other: Rehabilitation

Control

PLACEBO COMPARATOR

As a patient education, information was given about the disease and treatment process, listening to the patient during this process and getting regular sleep, balanced nutrition and taking a break from smokers.

Other: Rehabilitation

Interventions

Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.

ControlPulmonary Rehabilitation

Eligibility Criteria

Age28 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 28-45, positive COVID-19 test, being in the post-acute period, having symptoms of mild-moderate severity, respiratory rate ≤40 breaths / min, patients who can make video speech

You may not qualify if:

  • Severe symptom involvement, fever more than 38 degrees, obese patients, patients with multiple comorbidities, patients with one or more organ failure, oxygen saturation in the blood ≤95%, a resting blood pressure of \<90/60 mmHg or\> 140 / 90 mmHg patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Bilgi University

Istanbul, 34440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19DyspneaFatiguePainAnxiety Disorders

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tomri̇s Duymaz

    Istanbul Bilgi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

April 26, 2020

First Posted

April 28, 2020

Study Start

March 11, 2020

Primary Completion

April 10, 2020

Study Completion

April 26, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations