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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05493384
Other study ID # 7099
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 25, 2022
Est. completion date November 20, 2022

Study information

Verified date August 2022
Source Gazi University
Contact Songul B Yentur
Phone +90 424 2370000
Email songulbaglan23@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Telerehabilitation (TR) became more popular during COVID-19 pandemic due to social isolation and curfew. Exercise is one of treatments for patients with rheumatic diseases that are known to have low levels of physical activity.


Description:

Telerehabilitation (TR) aims to decrease barriers such as distance, time and cost by using technology to patients and clinicians. It provides to obtain rehabilitation for patients who cannot go to a medical center due to physical, environmental or economic inadequacies. COVID-19 is a contagious respiratory disease that is caused Severe Acute Respiratory Syndrome causing Coronavirus-2 (SARS-CoV-2). It was firstly seen in December 2019 in Wuhan, China and spread rapidly all over the world. World Health Organization (WHO) was declared COVID-19 as a pandemic in March 2020. The most common symptoms are fever, cough and dyspnoea. Social isolation and staying home have been suggested to reduce the spreading rate of COVID-19 pandemic in many countries. In addition, curfew except necessity was applied in some countries and time of curfew varied by country. Patients with rheumatic diseases are at higher risk of infections because of disease activity and immunosuppression. In addition, old age and having concomitant chronic disease are among risk factors for coronavirus. Therefore, national health services recommend patients to practice self-isolation and self-quarantine. However, social isolation was concluded with more increased physical inactivity and sedentary lifestyle. Physical inactivity and disuse are proven to cause joint destruction, decreased aerobic capacity and muscle atrophy in patients with rheumatic diseases.The importance and requirement for TR were observed better during the COVID-19 pandemic. Therefore, aim of this study was to investigate the effects of TR on fatigue, depression, anxiety, sleep quality, disease activity and quality of life.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 20, 2022
Est. primary completion date October 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Between the ages of 18 to 65 - Have diagnosed with Romatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erthematosus or Fibromyalgia Exclusion Criteria: - Being pregnant - Diagnosed with malignancy - Had changes of medical treatment in the last 3 months - Had dysfunction that limited physical activity such as severe neurological impairment, immobility or cooperation deficits - Had regular exercise habit (minimally three days in a week) - Had cardiac symphtoms according to New York Heart Association

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Telerehabilitation Group
The program will include stretching, strengthening, breathing, posture, proprioceptive, relaxation exercises and segmental extremity movements. Each exercise will be performed 10 times in a session for the first 4 weeks and 15 times for the last 4 weeks. Exercises will be performed progressively on the patients.

Locations

Country Name City State
Turkey Songul Baglan Yentur Elazig

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue severity scale Fatigue is a normal response to physical exertion or stress but can also be a sign of a physical disorder. In the common sense, fatigue is a condition known to everyone from his or her own experience,irrespective of his or her age, gender, or health. Fatigue severity scale consists of nine questions; each question is scored from 1 to 7 2 minutes
Primary Hospital Anxiety and Depression Scale It consists of 14 questions that which 7 of them evaluate depression and 7 of them evaluate anxiety. Each question is scored from 0 to 3 and high scores indicate severe anxiety and depression 2 minutes
Secondary Pittsburg Sleep Quality Index It assesses sleep quality and disturbances over a month's time interval and consists of 19 self-rated items and five questions.It contains 7 subscales and total score is sum of these subscales. Each item is scored 0-3 and total score is changed between 0 to 21 which high scores indicate worse sleep quality. 3 minutes
Secondary Health Assessment Questionnaire The questions of Health Assessment Questionnaire are about dressing and grooming, arising, eating, walking, hygiene, reach, grip and activity. The questionnaire consists of 20 questions and each question is scored from 0 to 3. Higher scores indicate worse quality of life 2 minutes
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