NCT04402983

Brief Summary

Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength can be observed in individuals who have been diagnosed with COVID19 and have been discharged. In our study, it was aimed to investigate the effect of telerehabilitation physical therapy intervention to these cases by using videoconferencing method on the physical condition of the cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started May 2020

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 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 27, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 14, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 22, 2020

Last Update Submit

December 11, 2020

Conditions

Keywords

exercisevideoconference

Outcome Measures

Primary Outcomes (5)

  • Modified Medical Research Council Dyspnea Score

    The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "O" means no dyspnea perception, "4" means severe dyspnea perception.

    Baseline to 6 weeks

  • Timed up and go test

    The Timed "Up and Go" (TUG) Test measures, in seconds, the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm, arm height 65 cm), walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down. Normal healthy elderly usually complete the task in 10 seconds or less. Very frail or weak elderly with poor mobility may take 2 minutes or more. Clinical guide: \<10 seconds = normal \<20 seconds = good mobility, can go out alone, mobile without a gait aid \<30 seconds = problems, cannot go outside alone, requires a gait aid A score of more than or equal to 14 seconds has been shown to indicate high risk of falls.

    Baseline to 6 weeks

  • Visual analog scale to assess the pain severity

    Visual analog scale to assess the pain on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.

    Baseline to 6 weeks

  • The Short Physical Performance Battery (SPPB)

    The Short Physical Performance Battery (SPPB) is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), a 4-m habitual gait speed, and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points. The total score is 12 points and this represents the highest performance. It can be easily performed at home via video conferencing

    Baseline to 6 weeks

  • Visual analog scale to assess the fatigue severity

    Visual analog scale to assess the fatigue severity on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100) score.

    Baseline to 6 weeks

Secondary Outcomes (2)

  • BECK depression inventory

    Baseline to 6 weeks

  • Saint George Respiratory Questionnaire

    Baseline to 6 weeks

Study Arms (2)

Telerehabilitation Group

EXPERIMENTAL

Physiotherapy will be carried out by conducting online conference method. Program content; Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking

Other: Physiotherapy

Control group

NO INTERVENTION

Information and exercise brochure will be provided

Interventions

Program content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking

Telerehabilitation Group

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-75
  • Being diagnosed with COVID19 and being discharged by being treated
  • Having technological facilities suitable for telerehabilitation access

You may not qualify if:

  • Any presence of comorbidity that may prevent them from exercising
  • Not agreeing to be included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (1)

  • Pehlivan E, Palali I, Atan SG, Turan D, Cinarka H, Cetinkaya E. The effectiveness of POST-DISCHARGE telerehabilitation practices in COVID-19 patients: Tele-COVID study-randomized controlled trial. Ann Thorac Med. 2022 Apr-Jun;17(2):110-117. doi: 10.4103/atm.atm_543_21. Epub 2022 Apr 19.

MeSH Terms

Conditions

COVID-19Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Esra Pehlivan, PhD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 22, 2020

First Posted

May 27, 2020

Study Start

May 27, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 14, 2020

Record last verified: 2020-05

Locations