Tele-Rehabilitation in Individuals With Covid-19

NCT05305638 | Completed

• 1 other identifier: Covid-19
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Covid-19; Breathing; Quality of Life; Physical Activity; Fatigue

Outcome Measures

Primary Outcomes (6)

• The Fear of COVID-19 Scale

  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.

  baseline to 6 week after

• MRC Dyspnea Scale

  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).

  baseline

• International Physical Activity Questionnaire-Short Form

  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".

  baseline to 6 week after

• St. George's Respiratory Questionnaire, SGRQ

  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.)

  baseline to 6 week after

• Fatigue Severity Scale

  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.

  baseline to 6 week after

• Nottingham Health Profile

  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.

  baseline to 6 week after

Study Arms (2)

Experimental Group

EXPERIMENTAL

Other: Exercise

Control Group

EXPERIMENTAL

Other: Exercise

Interventions

Exercise OTHER

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• Sun J, He WT, Wang L, Lai A, Ji X, Zhai X, Li G, Suchard MA, Tian J, Zhou J, Veit M, Su S. COVID-19: Epidemiology, Evolution, and Cross-Disciplinary Perspectives. Trends Mol Med. 2020 May;26(5):483-495. doi: 10.1016/j.molmed.2020.02.008. Epub 2020 Mar 21.

  PMID: 32359479 BACKGROUND

• MS AG, N.; Surendran, P.; Jacob, P.; Karpouzis, V.; Haneef, M.; Aleef, M.; Ali, S.; Praveen, R.; Bouguerra, E.; Almudahka,. Acute Care Physiotherapy Management of COVID-19 Patients in Qatar: Best Practice Recommendations. Preprints. 2020.

  BACKGROUND

• Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

  PMID: 32109013 BACKGROUND

• Gattinoni L, Coppola S, Cressoni M, Busana M, Rossi S, Chiumello D. COVID-19 Does Not Lead to a "Typical" Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2020 May 15;201(10):1299-1300. doi: 10.1164/rccm.202003-0817LE. No abstract available.

  PMID: 32228035 BACKGROUND

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration; Motor Activity; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Emine Nur Demircan, PT, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physiotherapist

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: March 31, 2022
• Study Start: April 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: October 15, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)