NCT05205434

Brief Summary

Investigators aimed to evaluate the effectiveness of exercise programs given by synchronous and asynchronous telerehabilitation methods in patients after discharge from COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Sep 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2022

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

January 19, 2022

Last Update Submit

March 8, 2023

Conditions

Keywords

COVID-19TelerehabilitationExercise programBreathing exercises

Outcome Measures

Primary Outcomes (1)

  • Incremental Shuttle Walk Test (ISWT)

    The participant will be asked to walk around two 9-meter cones and complete them within the given time. Oxygen saturation and heart rate will be measured before and immediately after the test. They will be asked to self-report dyspnea and fatigue according to the modified Borg scale (0-10).

    Change from baseline walking distance (meters) of the patients at the end of the 8th week and, postintervation sixth months

Secondary Outcomes (2)

  • 30-Second Chair Stand Test (30 CST)

    Change from baseline number of sitting and staying of the patients at the end of the 8th week and, postintervation sixth months

  • Brief Physical Performance Battery (BPPB)

    Change from baseline score of the patients at the end of the 8th week and, postintervation sixth months

Other Outcomes (7)

  • Oxygen Saturation and Heart Rate

    Change from baseline oxygen saturation (SaO2) and heart rate (beats per minute) of the patients at the end of the 8th week and, postintervation sixth months

  • Dyspnea and Fatigue Level

    Change from baseline dyspnea and fatigue of the patients at the end of the 8th week and, postintervation sixth months

  • Timed Up-Go Test (TUG)

    Change from baseline time (second) of the patients at the end of the 8th week and, postintervation sixth months

  • +4 more other outcomes

Study Arms (3)

Synchronous telerehabilitation program (Video conference)

EXPERIMENTAL

Participants will exercise program at home for an average of 30 minutes a day, 3 days a week, under the supervision of a physiotherapist via synchronized video conference. The program will continue for 8 weeks. The exercise program will consist of physical exercises (aerobic and strength exercises) along with breathing exercises and an educational program. Physical exercises will be adjusted in 3 different difficulty levels: sitting, standing with or without support.

Other: Synchronous telerehabilitation programme

Asynchronous telerehabilitation programme (Mobil app.)

EXPERIMENTAL

The same exercises as in the synchronous telerehabilitation program will be done at the same frequency. Participants will watch the videos sent by the investigator via the mobile application and then do the exercises at home. The participants will meet with the investigator once a week to an update exercise program.

Other: Asynchronous telerehabilitation programme

Control

NO INTERVENTION

Participants in this group will only receive an educational program

Interventions

Exercise program and educational program

Also known as: Video conference
Synchronous telerehabilitation program (Video conference)

Exercise program educational program

Also known as: Mobil application
Asynchronous telerehabilitation programme (Mobil app.)

Eligibility Criteria

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

You may qualify if:

  • COVID-19 patients in the subacute period discharged
  • Be 18 years or older
  • Having received oxygen therapy or mechanical ventilation support in the hospital
  • Access to online interviews and web-based exercises with a secure internet connection
  • Having sufficient speaking and hearing skills for telerehabilitation
  • Volunteer to participate in research

You may not qualify if:

  • Unstable clinical condition
  • Having had cerebrovascular disease, intra-articular drug injection or surgery of the lower extremities in the last 6 months
  • Inability to walk independently, even with an assistive device
  • Having serious neuromuscular problems
  • Not being cooperative enough to answer and understand questionnaires and scales

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Maltepe, Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Abdurrahman TANHAN, MSc

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 19, 2022

First Posted

January 25, 2022

Study Start

September 25, 2021

Primary Completion

August 5, 2022

Study Completion

September 7, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations