- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05787340
Investigation From Biopsychosocial Perspective of Patients With Rheumatic Disease With Covid-19 Who Participated in a Biopsychosocial Exercise Program: A Case Series With 6-Month Follow-up
Objective: This novel study aimed to interrogate from a biopsychosocial perspective the health conditions during the Covid-19 infection and long-Covid periods of 5 patients with rheumatic disease infected with Covid-19 who had acquired the habit of regular exercise before the pandemic.
Method: This case study included five patients suffering from Covid-19 infection among patients with rheumatic disease who had acquired the habit of regular exercise before the Covid-19 pandemic. It was applied a questionnaire to the patients from a biopsychosocial perspective to see the short and long-term effects of Covid-19 during and after quarantine. Moreover, the study used the BETY-Biopsychosocical Questionnaire (BETY-BQ) to evaluate a biopsychosocial point, Health Assessment Questionnaire (HAQ) to measure functional status, and the Hospital Anxiety and Depression Scale (HADS) to assess anxiety and depression.
Results: In BETY-BQ, HAQ, and HADS, there was an unfavorable increase in overall scores of all patients during Covid-19. After six months, although the results from these three scales improved, some of the patients could not return to their pre-covid state.
Conclusions: The patients participating in the telerehabilitation were able to return to everyday life after Covid more efficiently and overcome post-Covid symptoms easily. This study is important in guiding the exercise approach for patients with rheumatic diseases in pandemics such as Covid-19.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kahramanmaraş, Turkey, 46000
- Nazli Elif Nacar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with the rheumatic disease passed for at least six months after their Covid-19 infection between the ages of 18-65 were included in the study.
Exclusion Criteria:
- Exclusion criteria were the presence of deformity that does not allow exercise, cardiopulmonary disorders, uncontrolled endocrine system diseases, severe psychiatric illnesses, and insufficient skills in using a smartphone.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BETY exercise group
intervention group Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model via telerehabilitation Exercise dosage is 60 minute three days a week. |
Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach) is a group exercise method that conforms to the biopsychosocial model via telerehabilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative research
Time Frame: at 6 month
|
We aimed to complete qualitative interviews to investigate the biopsychosocial perspectives of patients with rheumatic diseases in the study.
A team of four physiotherapists experienced in rheumatic diseases prepared an interview guide based on prior studies in the literature.
The interview guide consisted of 25-item questions from a biopsychosocial perspective to see the short and long-term effects of Covid-19 infection on these patients during and after quarantine.
|
at 6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bilişsel Egzersiz Terapi Yaklaşımı-Biopsychosocial Questionnaire (BETY-BQ)
Time Frame: before infection, during infection and at 6 month after infection
|
The scale consists of 30 items.
The scoring of the scale was made using a 5-point Likert system.
Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and gives a total score over 30 items.
A high score means that the biopsychosocial situation is 'bad'.
|
before infection, during infection and at 6 month after infection
|
|
Health Assessment Questionnaire (HAQ)
Time Frame: before infection, during infection and at 6 month after infection
|
The functional status of the patients was determined by the Health Assessment Questionnaire.
The 20-question scale has 8 subtitles that include dressing, sitting, eating, walking, hygiene, reaching out, grasping, and daily life activities.
Each answer is scored between 0 and 3 points.
It means "0 = Without difficulty, 1 = A little difficult, 2 = Very difficult and 3 = I can never do it".
The total score is the average score derived from 8 points for each category.High score indicates low functional status.
|
before infection, during infection and at 6 month after infection
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: before infection, during infection and at 6 month after infection
|
The anxiety and depression of the patients was determined by Hospital Anxiety and Depression Scale (HADS).
This questionnaire is consisting of 14 questions with 4 options.
The higher the score, the higher the anxiety and depression levels.
|
before infection, during infection and at 6 month after infection
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kahramanmaras S I U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatic Diseases
-
Xijing HospitalAir Force Military Medical University, ChinaUnknownRheumatic Valve DiseaseChina
-
Assiut UniversityNot yet recruitingRheumatic Mitral Valve Disease
-
Assistance Publique - Hôpitaux de ParisRecruitingChronic Inflammatory Rheumatic Diseases of Childhood | Juvenile-Onset Chronic Inflammatory Rheumatic Diseases | Transition of Care in Chronic Inflammatory Rheumatic DiseasesFrance
-
Assiut UniversityRecruitingFollow up of Moderate Aortic Regurge After Rheumatic Mitral Valve ReplacementEgypt
-
African Academy of Methodology and StatisticsSuspendedRheumatic Heart Disease in ChildrenSenegal
-
Children's National Research InstituteUniversity of Cape Town; Thrasher Research Fund; Murdoch Childrens Research Institute and other collaboratorsUnknownHeart Diseases | Rheumatic Heart Disease | Rheumatic Heart Disease in Children | Latent Rheumatic Heart DiseaseUganda
-
Centre Hospitalier Universitaire de NiceCompleted
-
Ettore Sansavini Health Science FoundationUnknownTricuspid (Valve) Insufficiency (Rheumatic)Italy
-
University Hospital Inselspital, BerneInstituto de Cardiología Paredes-Horna, Arequipa; Hospital Nacional Carlos...CompletedRheumatic Heart Disease | Acute Rheumatic FeverPeru, Switzerland
-
Pamukkale UniversityActive, not recruiting
Clinical Trials on Bilişsel Egzersiz Terapi Yaklaşımı (BETY, Cognitive Exercise Therapy Approach)
-
Kahramanmaras Sutcu Imam UniversityHacettepe UniversityCompleted
-
Hacettepe UniversityRecruitingScleroderma, Localized | Scleroderma | Systemic Sclerosis (SSc) | Scleroderma Systemic | Scleroderma (Limited and Diffuse) | Juvenile Systemic Sclerosis | Systemic Sclerosis - 2013 ACR/EULAR Classification CriteriaTurkey (Türkiye)
-
Kahramanmaras Sutcu Imam UniversityCompletedPrimer Sjogren's SyndromeTurkey (Türkiye)
-
Eastern Mediterranean UniversityHacettepe UniversityCompletedRheumatic DiseasesTurkey (Türkiye)
-
Erkin Oğuz SARINot yet recruitingPost-Traumatic Stress DisorderTurkey
-
Hacettepe UniversityCompletedSystemic SclerosisTurkey
-
Hasan Kalyoncu UniversityCompleted
-
Hasan Kalyoncu UniversityCompletedHeadache | Temporomandibular DisordersTurkey (Türkiye)
-
Acibadem UniversityBezmialem Vakif UniversityRecruitingPrimary Dysmenorrhea | DysmenorrheaTurkey (Türkiye)