NCT05299333

Brief Summary

Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis. The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19. The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Sep 2022

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

First Submitted

Initial submission to the registry

March 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 4, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
Last Updated

April 4, 2025

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

March 25, 2022

Last Update Submit

April 1, 2025

Conditions

Keywords

Post covid fibrosisPulmonary RehabilitationPhysical Activity

Outcome Measures

Primary Outcomes (4)

  • Submaximal exercise capacity

    Six minute walk test and

    1 week-8 week

  • maximal exercise capacity

    Incremental shuttle walk test

    1 week-8 week

  • endurance exercise capacity

    endurance shuttle walk test

    1 week-8 week

  • Peripheral muscle strength

    Hand-held dynamometer

    1 week-8 week

Secondary Outcomes (9)

  • Physical activity

    1 week-8 week

  • Dyspnea

    1 week-8 week

  • Fatigue

    1 week-8 week

  • Physical fitness

    1 week-8 week

  • Functionality

    1 week-8 week

  • +4 more secondary outcomes

Study Arms (2)

Pulmonary Rehabilitation Group

EXPERIMENTAL

A total of 24 sessions of breathing exercises and high-repetitive muscle endurance and strengthening exercises will be applied to the pulmonary telerehabilitation group for 8 weeks, two days a week and one day a week unsupervised, via online systems. High-repetition muscle endurance and strengthening exercises will be applied to large muscle groups of the lower and upper extremities by creating resistance with body weight and theraband.

Other: Exercise

Physical Activity Group

ACTIVE COMPARATOR

Respiratory exercises and physical activity recommendations will be given to the physical activity group. Physical activity recommendations are; It will include information about the importance of physical activity and walking 3-5 days a week for at least 30 minutes of moderate intensity (4-6 on the Modified Borg scale of perceived exertion level).

Other: Exercise

Interventions

High repetition muscle endurance and strengthening exercises Walking

Physical Activity GroupPulmonary Rehabilitation Group

Eligibility Criteria

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

You may qualify if:

  • \>18 years old
  • Patients who have been infected with the COVID-19 virus at least three months ago and have been diagnosed with a positive PCR
  • Patients with post-COVID-19 pulmonary fibrosis followed by a pulmonologist
  • Patients who have sufficient technological infrastructure to participate in the telerehabilitation program and can adapt to online systems
  • Patients who are clinically stable

You may not qualify if:

  • Patients with orthopedic/neurological problems that prevent walking and exercise
  • Patients with uncontrolled cardiovascular disease
  • Patients with uncontrolled medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Pulmonary FibrosisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLung Diseases, InterstitialFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

March 25, 2022

First Posted

March 29, 2022

Study Start

September 4, 2022

Primary Completion

March 7, 2025

Study Completion

March 7, 2025

Last Updated

April 4, 2025

Record last verified: 2024-02

Locations