Telerehabilitation After Coronavirus

Telerehabilitation After Covid-19: Effectiveness of Respiratory and Aerobic Training

The aim of the study is to investigate the effects of telerehabilitation program on COVID-19 symptoms, quality of life, level of depression, perception of dyspnea, sleep, fatigue, kinesiophobia and patient satisfaction in individuals diagnosed with COVID-19.

Study Overview

• Status: Completed
• Conditions: COVID
• Intervention / Treatment: Behavioral: Patient Education; Other: Aerobic Exercise Training; Other: Respiratory Exercise Training

Detailed Description

Because of the risk of infection, telerehabilitation applications are recommended for patients with COVID-19. There are no studies in the literature evaluating the effectiveness of telerehabilitation program after COVID-19. In particular, the importance of the first eight weeks after the disease was emphasized.

It is thought that the telerehabilitation program will improve the functional capacities and quality of life of patients in order to adapt to the daily life after the infection more easily, to cope with the symptoms brought about by the disease more easily and to prevent the respiratory distress, intensive care stay and inactivity due to muscle weakness.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karatay
    • Konya, Karatay, Turkey, 42030
      • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• volunteering to participate in the study
• at least once diagnosed with COVID-19,
• has a cognitive level that can adapt to online exercises,
• having a physical condition suitable for exercises
• staying in hospital due to covid-19

Exclusion Criteria:

• refuse to participate in the study
• having neurological, cardiac, respiratory disease that prevents exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Patient Education Group; Information training about COViD-19 and its symptoms, hygiene education, family education	Behavioral: Patient Education; Patient education about covid-19 and hygiene education
EXPERIMENTAL: Aerobic Training Group; Teaching and regular follow-up of aerobic exercises shown online	Behavioral: Patient Education; Patient education about covid-19 and hygiene education; Other: Aerobic Exercise Training; Aerobic exercises using all body muscles and that one can do on their own after being shown online
EXPERIMENTAL: Aerobic + Respiratory Training Group; Teaching and regular follow-up of aerobic and respiratory exercises shown online	Behavioral: Patient Education; Patient education about covid-19 and hygiene education; Other: Aerobic Exercise Training; Aerobic exercises using all body muscles and that one can do on their own after being shown online; Other: Respiratory Exercise Training; Respiratory exercises that one can do on their own after being shown online

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnoea	It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.	baseline
Anxiety and Depression	It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.	baseline
Sleep Quality	It will be evaluated by pittsburgh sleep quality index	baseline
Health Related Quality of Life	It will be evaluated by SF-36	baseline
Dyspnoea	It will be evaluated by the Modified Medical Research Council (mMRC). It will be evaluated by the Modified Medical Research Council (mMRC). It consists of 5 items between 0 and 4. The increase in the score indicates the severity of dyspnea.	6 weeks later
Anxiety and Depression	It will be evaluated by the Hospital Anxiety and Depression Scale (HADS). The questionnaire comprises seven questions for anxiety and seven questions for depression, and takes 2-5min to complete. Although the anxiety and depression questions are interspersed within the questionnaire, it is vital that these are scored separately. Cut-off scores are available for quantification, for example a score of 8 or more for anxiety. The increase in the score indicates the severity of anxiety and depression.	6 weeks later
Sleep Quality	It will be evaluated by pittsburgh sleep quality index	6 weeks later
Health Related Quality of Life	It will be evaluated by SF-36	6 weeks later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia	It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement	baseline
Patient Satisfaction	It will be evaluated by patient satisfaction scale. Likert scale questionnaire proposed seven dimensions of patient satisfaction directed toward their doctors. These are general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Increased score indicates decreased satisfaction. The minimum score is 18, the maximum score is 90.	6 weeks later
Fatigue	It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.	baseline
Kinesiophobia	It will be evaluated by Kinesiophobia Causes Scale. The questionnaire consist of 20 closed questions, assessed in a range from 0 to 100 - a higher score indicating a higher fear of movement	6 weeks later
Fatigue	It will be evaluated by Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.	6 weeks later

Collaborators and Investigators

• Sponsor: KTO Karatay University
• Investigators: Study Director: Özlem Akkoyun Sert, Phd, PT, KTO Karatay University; Study Chair: Kamil Yılmaz, Phd, PT, KTO Karatay University; Study Chair: Osman Karaca, MsC,PT, KTO Karatay University; Study Chair: Hasan Gerçek, PT, KTO Karatay University; Study Chair: Bayram Sönmez Ünüvar, MsC, PT, KTO Karatay University; Study Chair: Sinan Bağçacı, Dr, KTO Karatay University; Study Chair: Büşra Alkan, MsC, PT, RA, KTO Karatay University; Study Chair: Melike Akdam, PT, RA, KTO Karatay University; Study Chair: Buse Kılınç, PT, KTO Karatay University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2020
• Primary Completion (ACTUAL): October 19, 2020
• Study Completion (ACTUAL): February 17, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (ACTUAL): July 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; Telerehabilitation; Aerobic Exercises; Respiratory Exercises
• Other Study ID Numbers: KaratayU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No