NCT05381675

Brief Summary

Most people who have coronavirus disease (COVID-19) recover completely without any sequelae. However, some patients continue to experience symptoms of COVID-19 even though their tests turn negative. This clinical spectrum that occurs after acute infection is called the post-COVID syndrome (PCS). Dyspnea, pain, decreased exercise capacity, limitations in activities of daily living, poor sleep quality, anxiety and depression are common symptoms in PCS. The aim of our study is to examine the effect of tele-rehabilitation-based exercise program on dyspnea, pain, functional capacity, sleep quality, anxiety and depression in individuals with PCS.

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 covid19

Timeline
Completed

Started May 2022

Typical duration 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

First Submitted

Initial submission to the registry

May 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

May 15, 2022

Last Update Submit

August 28, 2023

Conditions

Keywords

Tele-rehabilitationCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Change from the baseline to the 6th week in mMRC (Modified Medical Research Council) Dyspnoea Scale

    The mMRC Dyspnoea Scale is used to assess the degree of baseline functional disability due to dyspnoea

    Baseline and 6th week

Secondary Outcomes (4)

  • Change from the baseline to the 6th week in NPRS

    Baseline and 6th week

  • Change from the baseline to the 6th week in the 5 times sit to stand test (5XSST)

    Baseline and 6th week

  • Change from the baseline to the 6th week in the Hospital Anxiety and Depression Scale

    Baseline and 6th week

  • Change from the baseline to the 6th week in the The Pittsburgh Sleep Quality Index

    Baseline and 6th week

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive a supervised tele-rehabilitation program 2 days a week for 6 weeks.

Other: Tele-rehabillitation

Control

OTHER

Participants will receive the same rehabilitation program as prescribed.

Other: Prescribed Exercise Program

Interventions

Tele-rehabilitation program will be performed by physiotherapist two times a week for six consecutive weeks. Program including the following exercises: Breathing exercises Aerobic exercises Flexibility Strengthening exercises

Intervention

The prescribed exercise program will be performed two times a week for six consecutive weeks. Program including the following exercises: Breathing exercises Aerobic exercises Flexibility Strengthening exercises

Control

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between the ages of 18-75,
  • Being in stable medical condition, conscious and cooperative,
  • Having had COVID and continuing symptoms
  • Volunteering to participate in the study,
  • Own a device that can be connected online independently or with support from family members.

You may not qualify if:

  • SpO2 \< 92%,
  • Hypotension (Systolic Blood Pressure \< 90 mmHg or Diastolic Blood Pressure \< 60mmHg)
  • Having chronic respiratory disease (COPD, Asthma, etc.)
  • Having a stroke or neurodegenerative disease.
  • Not being willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Yasaci Z, Mustafaoglu R, Ozgur O, Kuveloglu B, Esen Y, Ozmen O, Yalcinkaya EY. Virtual recovery: efficacy of telerehabilitation on dyspnea, pain, and functional capacity in post-COVID-19 syndrome. Ir J Med Sci. 2025 Apr;194(2):631-640. doi: 10.1007/s11845-025-03899-3. Epub 2025 Feb 8.

MeSH Terms

Conditions

COVID-19Dyspnea

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 Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 15, 2022

First Posted

May 19, 2022

Study Start

May 20, 2022

Primary Completion

May 20, 2023

Study Completion

August 1, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Locations