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Telerehabilitation in Rheumatic Diseases

Primary Purpose

Telerehabilitation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation Group
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation focused on measuring Telerehabilitation, Rheumatic diseases, COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Songul Baglan YenturRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telerehabilitation group

No Intervention group

Arm Description

The Telerehabilitation Group will be performed exercise program including stretching, strengthening, posture and relaxation exercises by an experienced physiotherapist for 3 times a week for 8 weeks via Zoom.

No additional therapy will be performed to the Control Group and they were suggested to continue their usual physical activity.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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

Full Information

First Posted
August 2, 2022
Last Updated
August 6, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05493384
Brief Title
Telerehabilitation in Rheumatic Diseases
Official Title
Telerehabilitation in Rheumatic Diseases During the Process of COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Anticipated)
Study Completion Date
November 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation
Keywords
Telerehabilitation, Rheumatic diseases, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group
Arm Type
Experimental
Arm Description
The Telerehabilitation Group will be performed exercise program including stretching, strengthening, posture and relaxation exercises by an experienced physiotherapist for 3 times a week for 8 weeks via Zoom.
Arm Title
No Intervention group
Arm Type
No Intervention
Arm Description
No additional therapy will be performed to the Control Group and they were suggested to continue their usual physical activity.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue severity scale
Description
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
Time Frame
2 minutes
Title
Hospital Anxiety and Depression Scale
Description
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
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Pittsburg Sleep Quality Index
Description
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.
Time Frame
3 minutes
Title
Health Assessment Questionnaire
Description
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
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songul B Yentur
Phone
+90 424 2370000
Email
songulbaglan23@hotmail.com
Facility Information:
Facility Name
Songul Baglan Yentur
City
Elazığ
ZIP/Postal Code
23119
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songul B Yentur
Phone
+90 424 2370000
Email
songulbaglan23@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/26945913/
Description
Home tele-rehabilitation for rheumatic patients: impact and satisfaction of care analysis
URL
http://pubmed.ncbi.nlm.nih.gov/26945913/
Description
Efficacy of tele-rehabilitation compared with office-based physical therapy in patients with knee osteoarthritis: A randomized clinical trial

Learn more about this trial

Telerehabilitation in Rheumatic Diseases

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