The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04402983
Collaborator
(none)
34
1
2
6.2
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physiotherapy
N/A

Detailed Description

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. The exercise program will be a total of 6 weeks, 3 days a week. Online access will be carried out synchronously by telephone or computer, and training sessions will not be recorded in order to protect patient personal information. The cases will be evaluated online at the beginning of the study and at the end of the 6-week exercise program. The selected evaluation parameters have been selected considering the ease of online application.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled clinical trialRandomized controlled clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients
Actual Study Start Date :
May 27, 2020
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telerehabilitation Group

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
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

No Intervention: Control group

Information and exercise brochure will be provided

Outcome Measures

Primary Outcome Measures

  1. Modified Medical Research Council Dyspnea Score [Baseline to 6 weeks]

    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.

  2. Timed up and go test [Baseline to 6 weeks]

    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.

  3. Visual analog scale to assess the pain severity [Baseline to 6 weeks]

    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.

  4. The Short Physical Performance Battery (SPPB) [Baseline to 6 weeks]

    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

  5. Visual analog scale to assess the fatigue severity [Baseline to 6 weeks]

    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.

Secondary Outcome Measures

  1. BECK depression inventory [Baseline to 6 weeks]

    This is a 21-item self-assessment scale designed by Aaron Beck in 1961 to measure the risk and level of depression.

  2. Saint George Respiratory Questionnaire [Baseline to 6 weeks]

    The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Being between the ages of 18-75

  • Being diagnosed with COVID19 and being discharged by being treated

  • Having technological facilities suitable for telerehabilitation access

Exclusion Criteria:
  • Any presence of comorbidity that may prevent them from exercising

  • Not agreeing to be included in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Health Sciences Turkey İstanbul Turkey 34668

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

  • Principal Investigator: Esra Pehlivan, PhD, Saglik Bilimleri Universitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
esra pehlivan, Principal investigator, Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT04402983
Other Study ID Numbers:
  • Telerehab_Covid19
First Posted:
May 27, 2020
Last Update Posted:
Dec 14, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by esra pehlivan, Principal investigator, Saglik Bilimleri Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2020