Effect of Telerehabilitation Practice in Long COVID-19 Patients

NCT05817032 | Unknown

• 1 other identifier: 21-07-0713
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Long COVID-19; Telerehabilitation; rehabilitation; exercise

Outcome Measures

Primary Outcomes (4)

• 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

  European Quality of Life 5 Dimension 5 Level (EQ 5D 5L) questionnaire is a validated instrument to measure quality of life. It is a descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  Baseline and week 12

• Change from baseline the distance from Six Minute Walk Test at 12 weeks

  Six minute walk test is a validated instrument developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

  Baseline and week 12

• Change from baseline the mean Glutathione (GSH)/ oxidized GSH (GSSG) ratio at 12 weeks

  The ratio of reduced Glutathione (GSH) to oxidized GSH (GSSG) is an indicator of cellular health, with reduced GSH constituting up to 98% of cellular GSH under normal conditions. It will be measured using The Glutathione GSH/GSSG Assay Kit, which is designed to accurately measure total, reduced and oxidized glutathione in biological samples using an enzymatic method that utilizes Ellman's Reagent (DTNB) and glutathione reductase (GR).

  Baseline and week 12

• Change from baseline the mean endothelial microparticles at 12 weeks

  Endothelial microparticles is an emerging marker of endothelial dysfunction and also considered to play a major biological role in inflammation, vascular injury, angiogenesis, and thrombosis. Techniques to measure circulating endothelial microparticles rely on differential centrifugation in platelet-free plasma and on the identification of cell-surface Cluster of Differentiations (CD) antigens.

  Baseline and week 12

Secondary Outcomes (2)

• Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks

  Baseline and 12 weeks

• Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks

  Baseline and 12 weeks

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

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.

Behavioral: Telerehabilitation

Control group

ACTIVE COMPARATOR

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.

Behavioral: Standard rehabilitation care

Interventions

Telerehabilitation 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.

Telerehabilitation group

Standard rehabilitation care 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.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Nurul Paramita, MD, MBiomed

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurul Paramita, MD, MBiomed

CONTACT

6281281839593; nurul.paramita61@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr, M.Biomed, SpKFR

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: April 18, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

ID (1)