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Effect of Telerehabilitation Practice in Long COVID-19 Patients

Primary Purpose

Long COVID-19, Long COVID, Post COVID-19 Condition

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Telerehabilitation
Standard rehabilitation care
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Long COVID-19 focused on measuring Long COVID-19, Telerehabilitation, rehabilitation, exercise

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Fakultas Kedokteran Universitas IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation group

Control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 16, 2023
Last Updated
April 16, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05817032
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID-19, Long COVID, Post COVID-19 Condition, Post-COVID-19 Syndrome, Post-COVID Syndrome
Keywords
Long COVID-19, Telerehabilitation, rehabilitation, exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation
Intervention Description
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
Intervention Name(s)
Standard rehabilitation care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline and week 12
Title
Change from baseline the distance from Six Minute Walk Test at 12 weeks
Description
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.
Time Frame
Baseline and week 12
Title
Change from baseline the mean Glutathione (GSH)/ oxidized GSH (GSSG) ratio at 12 weeks
Description
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).
Time Frame
Baseline and week 12
Title
Change from baseline the mean endothelial microparticles at 12 weeks
Description
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.
Time Frame
Baseline and week 12
Secondary Outcome Measure Information:
Title
Change from baseline the score from Brief Fatigue Inventory (BFI) questionnaire at 12 weeks
Description
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.
Time Frame
Baseline and 12 weeks
Title
Change from baseline the score from hand grip strength test using handgrip dynamometer at 12 weeks
Description
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.
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nurul Paramita, MD, MBiomed
Phone
6281281839593
Email
nurul.paramita61@ui.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurul Paramita, MD, MBiomed
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fakultas Kedokteran Universitas Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurul Paramita, MD, MBiomed
Phone
6281281839593
Email
nurul.paramita61@ui.ac.id
First Name & Middle Initial & Last Name & Degree
Nurul Paramita, MD, MBiomed

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
individual participant data including study protocol and informed consent available upon personal request

Learn more about this trial

Effect of Telerehabilitation Practice in Long COVID-19 Patients

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