Clinical trial NCT05817032: Effect of Telerehabilitation Practice in Long COVID-19 Patients
Official title: Effect of Telerehabilitation Practice in Long COVID-19 Patients: Impact on Stress Oxidative, Inflammation, Functional Capacity and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Long COVID-19
Long COVID
Post COVID-19 Condition
Post-COVID-19 Syndrome
Post-COVID Syndrome
Keywords: Long COVID-19
Telerehabilitation
rehabilitation
exercise
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test the efficacy of telerehabilitation practice in Long COVID-19 patients. The main question\[s\] it aims to answer are whether telerehabilitation practice in Long COVID-19 patients help to reduce stress oxidative, reduce inflammation, improve functional capacity and improve quality of life.

Participants will receive 12 weeks of telerehabilitation practice Researchers will compare intervention group (that received telerehabilitation) and control group (that received standard treatment) to see if there is better outcome in intervention group.

Detailed description: Study background:

Several study show that some survivors of COVID-19 have post COVID-19 sequelae. Previous studies suggest that rehabilitation interventions with appropriate prescription of physical exercise can provide short, medium and long term health benefits. Telerehabilitation services are an innovative strategy to support rehabilitation intervention and hopefully able to increase compliance of patients to exercise program.

This study aims to prove the effectiveness of telerehabilitation in improving levels of inflammation, oxidative stress, functional capacity and quality of life in Long COVID-19 patients. Participants will be divided into intervention group and control group. Baseline measurement will be taken. Telerehabilitation will be given to the intervention group for 12 weeks. Control group will receive standard rehabilitation treatment. After 12 weeks post intervention measurement will be taken.

Eligibility criteria: Inclusion Criteria:

* COVID-19 survivors
* Have at least one of the following sequelae:
* fatigue
* dyspnea and/or chronic cough
* joint and/or muscle pain
* headache
* insomnia (difficulty sleeping)
* impaired concentration / memory
* Willing to take part in the telerehabilitation program regularly during the study
* Willing to participate in the research and sign the consent form

Exclusion Criteria:

* Unable to use the mobile phone application and zoom meet
* Unable to come to the hospital for examination or training (if needed)
* Cognitive impairment (MMSE \<21)
* Neuromusculoskeletal disorder which will affect rehabilitation interventions
* Severe chronic lung disease
* Severe heart disease (Grade III-IV from the New York Heart Association)
* Chronic kidney disorders
* Malignancy
* Severe autoimmune disease

Primary outcomes:
measure: Change from baseline in quality of life status measured using European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire at 12 weeks
timeFrame: Baseline and week 12
measure: Change from baseline the distance from Six Minute Walk Test at 12 weeks
timeFrame: Baseline and week 12
measure: Change from baseline the mean Glutathione (GSH)/ oxidized GSH (GSSG) ratio at 12 weeks
timeFrame: Baseline and week 12
measure: Change from baseline the mean endothelial microparticles at 12 weeks
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Nurul Paramita, MD, MBiomed
role: PRINCIPAL_INVESTIGATOR
References: