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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06251011
Other study ID # EC014/2565
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 9, 2024
Est. completion date June 15, 2024

Study information

Verified date February 2024
Source Chulabhorn Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effects of Physiotherapy Via Video Calls on Cardiopulmonary Functions, Physical Function, Cognitive Function, Activity Daily Livings, and Quality of Life in Patients With COVID-19.


Description:

A 2-armed, parallel-group, randomized controlled trial was conducted at Chulabhorn Hospital, Thailand on a convenience sample of patients who tested positive for COVID-19 using RT-PCR.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date June 15, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: - Age between 20-60 years old - Positive in COVID-19 testing - Good communication and understanding - Independent mobility Exclusion Criteria: - Cannot complete the study protocol

Study Design


Intervention

Behavioral:
Exercise training
Physical therapy training via video call An advise and a leaflet for cardiopulmonary rehabilitation

Locations

Country Name City State
Thailand Chulabhorn hospital Lak Si Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulabhorn Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiopulmonary function using Cardiopulmonary exercise testing (CPET) at day 28 and 90 after positive in COVID-19 testing
Primary Patient's quality of life using the The World Health Organization Quality of Life (WHOQOL-BREF-THAI) 26 items; the final score ranges from 24-120; higher score means participants satisfied with the quality of life. at day 3 and 21 after positive in COVID-19 testing
Primary Functional capacity using Duke Activity status index The final score ranges between zero and 58.2 points; The higher the score, the better the functional capacity. at day 3 and 21 after positive in COVID-19 testing
Primary Anxiety and depression using Hospital Anxiety and Depression Scale (HADS) The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. at day 3 and 21 after positive in COVID-19 testing
Primary Insomnia using Insomnia Severity Index (ISI) The final score ranges between zero and 28 points. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). at day 3 and 21 after positive in COVID-19 testing
Primary Cognitive function using Thai Mental State Examination The final score ranges between zero and 30 points. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. at day 3 and 21 after positive in COVID-19 testing
Primary Muscle strength using 1-minute sit to stand at day 3 and 21 after positive in COVID-19 testing
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