Tele-Rehabilitation in Individuals With Covid-19

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT05305638
Collaborator
(none)
50
1
2
3
16.9

Study Details

Study Description

Brief Summary

Coronavirus Disease (COVID-19) is a respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2). This study was planned as a single-blind randomized controlled pilot study to compare the effectiveness of telerehabilitation-based exercise training applied to individuals with Covid-19. Individuals will be divided into two groups, the control group and the study group. All assessments will be made online twice, before and after treatment. Socio-demographic data of individuals who agreed to participate in the study, disease information about Covid-19, MRC Dyspnea Scale, COVID-19 Fear Scale, International Physical Activity Questionnaire-Short Form, ST. George Respiratory Questionnaire, Fatigue Severity Scale, Nottingham Health Profile will be questioned and recorded. The obtained data will be analyzed with statistical methods.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effect of Telerehabilitation-Based Physiotherapy Training on Respiration, Quality of Life, Physical Activity and Fatigue in Individuals With Covid-19
Actual Study Start Date :
Dec 15, 2021
Actual Primary Completion Date :
Feb 15, 2022
Actual Study Completion Date :
Mar 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Other: Exercise
Home-based physical activity programs are very important to strengthen the immune system, which is extremely important in the fight against COVID-19 infection, and to protect physical and mental health. In addition, since the pulmonary rehabilitation sessions carry a high risk of transmission, it is recommended that the program be carried out with applications such as single-session training, tele-rehabilitation or home program. Although the home pulmonary rehabilitation program is adapted to the individual, it generally includes positioning, mobilization, relaxation exercises, respiratory training, respiratory muscle exercises, upper and lower extremity exercises, walking, climbing stairs and cycling exercises. The general opinion is that telerehabilitation practices have many benefits such as increasing the quality of life and physical activity. In addition to these benefits, telerehabilitation applications come to the fore in the Covid-19 period with its complementary feature.

Experimental: Control Group

Other: Exercise
Home-based physical activity programs are very important to strengthen the immune system, which is extremely important in the fight against COVID-19 infection, and to protect physical and mental health. In addition, since the pulmonary rehabilitation sessions carry a high risk of transmission, it is recommended that the program be carried out with applications such as single-session training, tele-rehabilitation or home program. Although the home pulmonary rehabilitation program is adapted to the individual, it generally includes positioning, mobilization, relaxation exercises, respiratory training, respiratory muscle exercises, upper and lower extremity exercises, walking, climbing stairs and cycling exercises. The general opinion is that telerehabilitation practices have many benefits such as increasing the quality of life and physical activity. In addition to these benefits, telerehabilitation applications come to the fore in the Covid-19 period with its complementary feature.

Outcome Measures

Primary Outcome Measures

  1. The Fear of COVID-19 Scale [baseline to 6 week after]

    The Fear of COVID-19 Scale was used to measure the level of fear caused by Covid-19. Each question of the scale, which consists of 7 questions, is graded on a 5-point Likert scale (1- I strongly disagree. 5- I strongly agree). A high score indicates greater fear of Covid-19.

  2. MRC Dyspnea Scale [baseline]

    The MRC Dyspnea Scale was used to assess the participants' dyspnea levels. It is a five-point scale based on various physical exercises that produce a feeling of dyspnea. It consists of five items. The person's respiratory distress is graded from 0 (no shortness of breath) to 4 (shortness of breath during activities such as being confined to home and dressing).

  3. International Physical Activity Questionnaire-Short Form [baseline to 6 week after]

    The physical activity levels of the participants were evaluated with the International Physical Activity Questionnaire-Short Form. The questionnaire assessing the level of physical activity over the past 7 days provides information about walking, moderate activities, and time spent sitting. Individuals' physical activity levels are divided into three categories according to the scores obtained: "inactive", "minimally active" and "very active".

  4. St. George's Respiratory Questionnaire, SGRQ [baseline to 6 week after]

    The quality of life of individuals, a test that measures health-related quality of life for respiratory diseases, ST. George Respiratory Questionnaire. st. George Respiratory Questionnaire; It has three sub-branches as symptoms (8 items), activities (16 items), and effects of the disease (26 items) and consists of a total of 50 items. The total score of the test is between 0-100 (0 score is normal, 100 indicates maximum disability.)

  5. Fatigue Severity Scale [baseline to 6 week after]

    The Fatigue Severity Scale, which measures the severity of fatigue in the last month, was used to determine the severity of fatigue. The scale consists of nine questions and each question is graded over seven points. The total score ranges from 9 to 63 points. High scores indicate fatigue, 28 points and above indicate the presence of severe fatigue.

  6. Nottingham Health Profile [baseline to 6 week after]

    The Nottingham Health Profile was also used to assess the participants' health-related quality of life. NSP is a general quality of life questionnaire that measures the individual's perceived health problems and the level of these problems that affect normal daily activities. The first part of the NSP, which was developed in two parts, consists of 38 items and evaluates six parameters related to health level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • A score in the range of 0-3 on the MRC Dyspnea Scale.

  • Not have any vestibular, orthopedic or neurological disease that will affect muscle strength, balance and coordination.

  • Not having undergone surgery in the last 6 months.

  • Not having undergone any surgical procedure that may affect the musculoskeletal system of the spinal column, lower extremities or upper extremities.

  • It was being cooperative and volunteering.

Exclusion Criteria:
  • Severe liver and kidney disease or new and progressive damage to liver and kidney function, deep vein thrombosis and pulmonary embolism, suspected aortic stenosis, having a disease/condition for which exercise is contraindicated.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Ankara Turkey

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: Emine Nur Demircan, PT, MSc, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Emine Nur Demircan, Specialist Physiotherapist, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05305638
Other Study ID Numbers:
  • Covid-19
First Posted:
Mar 31, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Emine Nur Demircan, Specialist Physiotherapist, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022