Effect of Telerehabilitation Practice in Long COVID-19 Patients

NCT ID: NCT05817032

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2023-11-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Telerehabilitation group

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.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: BEHAVIORAL

Exercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have a hybrid approach (10-12 in person, 24-26 virtual) or fully virtual.

Control group

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.

Group Type: ACTIVE_COMPARATOR

Standard rehabilitation care

Intervention Type: BEHAVIORAL

Exercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have 10-12 in person exercise.

Interventions

Telerehabilitation

Exercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have a hybrid approach (10-12 in person, 24-26 virtual) or fully virtual.

Intervention Type: BEHAVIORAL

Standard rehabilitation care

Exercise prescriptions will be given based on the result of baseline assessment. The intensity of the exercise prescription and level of monitoring will be tailored to each participant's ability and condition. Exercise will be prescribed by a Physical Medicine and Rehabilitation specialist in accordance with standard rehabilitation protocols. Exercise will consist of aerobic exercise, resistance exercise and breathing exercise. Participants are asked to commit to do at least 36 sessions of exercise. Participants will be allowed to have 10-12 in person exercise.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Nurul Paramita

dr, M.Biomed, SpKFR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nurul Paramita, MD, MBiomed

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Nurul Paramita, MD, MBiomed

Role: CONTACT

nurul.paramita61@ui.ac.id

6281281839593

Facility Contacts

Nurul Paramita, MD, MBiomed

Role: primary

nurul.paramita61@ui.ac.id

6281281839593

Other Identifiers

21-07-0713

Identifier Type: -

Identifier Source: org_study_id