Effect of Telerehabilitation Practice in Long COVID-19 Patients

University of Indonesia (UI)

Status: Enrolling

Conditions: Post COVID-19 Condition; Post-COVID Syndrome; Long COVID; Long COVID-19; Post-COVID-19 Syndrome

Treatments: Behavioral: Telerehabilitation; Behavioral: Standard rehabilitation care

Study type: Interventional

Funder types: Other

Identifiers

NCT05817032

21-07-0713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Telerehabilitation group

Experimental group

Description:

Baseline measurement will be done in the rehabilitation center. Prescription for rehabilitation will be determined based on the result of baseline measurement. Participants will receive rehabilitation intervention that include telerehabilitation (video conference regular meeting, text message reminder, and mobile app). Participants will attend a regular check up at the center once a month. After 12 weeks post intervention measurement will be taken.

Treatment:

Behavioral: Telerehabilitation

Control group

Active Comparator group

Description:

Baseline measurement will be done in the rehabilitation center. Prescription for rehabilitation will be determined based on the result of baseline measurement. Participants will be given instruction how to do proper exercise training at home. Participants will attend a regular check up at the center once a month. After 12 weeks post intervention measurement will be taken.

Treatment:

Behavioral: Standard rehabilitation care