Effect of Telerehabilitation Practice in Long COVID-19 Patients

Effect of Telerehabilitation Practice in Long COVID-19 Patients: Impact on Stress Oxidative, Inflammation, Functional Capacity and Quality of Life

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.

Study Overview

• Status: Recruiting
• Conditions: Post-COVID-19 Syndrome; Long COVID; Post COVID-19 Condition; Post-COVID Syndrome; Long COVID-19
• Intervention / Treatment: Behavioral: Telerehabilitation; Behavioral: Standard rehabilitation care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nurul Paramita, MD, MBiomed; Phone Number: 6281281839593; Email: nurul.paramita61@ui.ac.id

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Fakultas Kedokteran Universitas Indonesia
      • Contact: Nurul Paramita, MD, MBiomed; Phone Number: 6281281839593; Email: nurul.paramita61@ui.ac.id
      • Principal Investigator: Nurul Paramita, MD, MBiomed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks	Brief Fatigue Inventory (BFI) questionnaire is a valid instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. A global fatigue score can be obtained by averaging all the items on the BFI.	Baseline and 12 weeks
Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks	The purpose of the handgrip strength test is to measure the maximum isometric strength of the hand and forearm muscles. Handgrip strength is important because people with strong hands tend to be strong elsewhere, so this test is often used as a general test of strength.	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Nurul Paramita, MD, MBiomed, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: exercise; Long COVID-19; rehabilitation; Telerehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: 21-07-0713

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: individual participant data including study protocol and informed consent available upon personal request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No