NCT04473898

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

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

June 19, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2021

Completed
Last Updated

February 18, 2021

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 14, 2020

Last Update Submit

February 17, 2021

Conditions

Keywords

Covid-19TelerehabilitationRespiratory ExercisesAerobic Exercises

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (5)

  • Kinesiophobia

    baseline

  • Patient Satisfaction

    6 weeks later

  • Fatigue

    baseline

  • Kinesiophobia

    6 weeks later

  • Fatigue

    6 weeks later

Study Arms (3)

Patient Education Group

SHAM COMPARATOR

Information training about COViD-19 and its symptoms, hygiene education, family education

Behavioral: Patient Education

Aerobic Training Group

EXPERIMENTAL

Teaching and regular follow-up of aerobic exercises shown online

Other: Aerobic Exercise TrainingBehavioral: Patient Education

Aerobic + Respiratory Training Group

EXPERIMENTAL

Teaching and regular follow-up of aerobic and respiratory exercises shown online

Other: Aerobic Exercise TrainingBehavioral: Patient EducationOther: Respiratory Exercise Training

Interventions

Aerobic exercises using all body muscles and that one can do on their own after being shown online

Aerobic + Respiratory Training GroupAerobic Training Group

Patient education about covid-19 and hygiene education

Aerobic + Respiratory Training GroupAerobic Training GroupPatient Education Group

Respiratory exercises that one can do on their own after being shown online

Aerobic + Respiratory Training Group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, 42030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Patient Education as TopicBreathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Özlem Akkoyun Sert, Phd, PT

    KTO Karatay University

    STUDY DIRECTOR
  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: It is planned to include 3 groups in the study. The group 1 will be informed about covid-19 and hygiene. Aerobic exercise will be offered to Group 2, aerobic exercise + breathing exercises will be offered to Group 3. The persons to be included in the groups will be determined randomly.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 16, 2020

Study Start

June 19, 2020

Primary Completion

October 19, 2020

Study Completion

February 17, 2021

Last Updated

February 18, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations