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Post-Coronavirus Disease of 2019 (COVID-19) Rehabilitation Clinics in Saudi Arabia

Primary Purpose

Fatigue, Cardiopulmonary Arrest, Physical Inactivity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Therapy Rehabilitation
Sponsored by
Majmaah University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring Rehabilitation, Coronavirus disease, Respiratory function, 6-min walk test, Physical Therapy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The participants' ages from 18-45 years old Participants who are referred to the post-COVID clinics Participants who are discharged from the hospitals within 3 to 6 months ago. Exclusion Criteria: If they have any active infection such as pneumonia, cardiovascular instability, pulmonary embolism, and disability or disorders. Musculoskeletal disorders Neurodegenerative diseases Patients unable to walk.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Rehabilitation

    Arm Description

    The duration for 4-week, three sessions per week. Each session will last for 45-60 minutes

    Outcomes

    Primary Outcome Measures

    6-min walk test (6-MWT)
    Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
    Time Up and Go (TUG) test
    Measures the time needed to get up from a chair, walk 3 meters, and then return and sit back on a chair.
    1-min sit-to-stand test (1-MSTST)
    To stand up and sit down on a chair without arm rests as many times as possible within 1 min.

    Secondary Outcome Measures

    10-meter walk test (10MWT)
    Measure used to assess walking speed in meters per second over a short distance of 14-meters.

    Full Information

    First Posted
    April 4, 2023
    Last Updated
    April 4, 2023
    Sponsor
    Majmaah University
    Collaborators
    King Fahad Medical City
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05799534
    Brief Title
    Post-Coronavirus Disease of 2019 (COVID-19) Rehabilitation Clinics in Saudi Arabia
    Official Title
    Post-COVID-19 Rehabilitation Clinics in Saudi Arabia: Improves Physical Status, Dyspnea, Fatigue, Anxiety, and Quality of Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    July 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Majmaah University
    Collaborators
    King Fahad Medical City

    4. Oversight

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

    5. Study Description

    Brief Summary
    This intervention study aims to evaluate the before and after changes in physical fitness, cardiorespiratory status, exercise capacity, fatigue, anxiety, dyspnea, psychoemotional conditions, and quality of life through 3 sessions per week for 4-week of an intensive therapeutic program in post coronavirus survivors. In addition, it aims to answer the main questions before and after the clinical trial study. Does three sessions per week for 4-week of an intensive therapeutic program improve patients' physical fitness, cardiorespiratory status, and exercise capacity? Does it improve physical endurance and fitness, enhancing fatigue, anxiety, and dyspnea on post coronavirus patients? Participants will ask first to answer these questionnaires before and after the intervention. Berg Balance Scale (BBS): to assess the patient's ability (or inability) to safely balance (standing, active, and fall risk) during a series of planned tasks. The Modified Medical Research Council (mMRC) Dyspnea Scale: is used to assess patients' degree of baseline functional impairment due to dyspnea from respiratory diseases. Depression, Anxiety, and Stress Scale- 21 Items (DASS-21): measures the emotional states of depression, anxiety, and stress. Fatigue Assessment Scale (FAS): evaluates symptoms of chronic fatigue. Quality of Life (QOL)-short form-36: to assess the quality of life and calculate eight subscales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. After answering the questionnaires, the patients will then go through multiple tests before and after the intervention: A 6-min walk test (6-MWT): is the primary measure of this study to assess aerobic capacity and endurance. 10-meter walk test (10MWT): assess walking speed in meters per second over a short distance and assess capacity and endurance. Time Up and Go (TUG) test: assess lower extremity function, mobility, and fall risk. The TUG test is the shortest, most straightforward clinical balance test available to predict the risk of falls. 1-min sit-to-stand test (1-MSTST): assess lower extremity strength for one minute.
    Detailed Description
    The intervention will include all of the following exercises: Breathing Exercises: Breathing control: • Start with the breathing exercises at least twice a day, and increase to 4-6 times a day • Breathe in and out gently through the nose if possible. If the breath is out through the mouth, the participant will instruct to purse their lips as if they are blowing out a candle Attempt to release any tension in the body with each exhalation Gradually try to make the breaths slower Each participant will instruct to close their eyes to help focus on breathing and to relax Deep breathing exercises The participant will be instructed to take long, slow, and deep breaths through their nose and keep their chest and shoulders relaxed. Breathe out gently and relax, like a sigh. They should do three-five deep breaths. Repeat for two minutes several times a day. Huffing • A huff is exhaled through an open mouth and throat instead of coughing. It helps move sputum up the participants' airways so they can clear it in a controlled way. To "huff," they must squeeze air quickly from their lungs through their open mouth and throat as if trying to mist up a mirror or glasses. Use their abdominal muscles to assist them in squeezing out the air, but do not exert so much force that it causes wheezing or chest tightness. If huffing clears their sputum, they should not need to cough. They should only cough if the sputum can clear quickly. The participants should continue the breathing exercises for about 10 minutes, ideally until their chest feels clear of sputum. Strengthening Exercises - To help restore muscle strength and increase endurance for 3 minutes daily. Standing heel raise: hold on a chair, integrate arms reaching overhead when on toes. Repeat 2-3 times. Increase gradually to 8 Times (1-set) Mini squats holding the chair with breathing Wall push-ups hold for 8 seconds, then repetitions 2-3 times and increase to 10 repetitions. For core exercises, start with 1-2 repetitions, then slowly increase to 10 repetitions. Sit to stand and repeat 2-3 times. Increase gradually to 10-times Mobility training or gait training - To increase endurance Walk for at least 30 minutes without stopping five times per week Start by walking on flat surfaces. As they progress and gain endurance, increase challenge by walking on hills and inclines for a 10-minute increase to 3 times a day. Ascending and descending stairs with assistance if needed. Home-exercise program (HEP) • All the activities above should continue at home

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatigue, Cardiopulmonary Arrest, Physical Inactivity, Muscle Weakness, Stress, Emotional, Dyspnea
    Keywords
    Rehabilitation, Coronavirus disease, Respiratory function, 6-min walk test, Physical Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Before and after intervention program
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Rehabilitation
    Arm Type
    Experimental
    Arm Description
    The duration for 4-week, three sessions per week. Each session will last for 45-60 minutes
    Intervention Type
    Other
    Intervention Name(s)
    Physical Therapy Rehabilitation
    Intervention Description
    Physical Therapy Rehabilitation program to to establish a novel physiotherapeutic plan to determine the effects on post-COVID-19 patients' psychoemotional condition, lung capacity, cardiorespiratory condition, and muscle strength.
    Primary Outcome Measure Information:
    Title
    6-min walk test (6-MWT)
    Description
    Measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.
    Time Frame
    6 minutes
    Title
    Time Up and Go (TUG) test
    Description
    Measures the time needed to get up from a chair, walk 3 meters, and then return and sit back on a chair.
    Time Frame
    Less 1 minute
    Title
    1-min sit-to-stand test (1-MSTST)
    Description
    To stand up and sit down on a chair without arm rests as many times as possible within 1 min.
    Time Frame
    1 minute
    Secondary Outcome Measure Information:
    Title
    10-meter walk test (10MWT)
    Description
    Measure used to assess walking speed in meters per second over a short distance of 14-meters.
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The participants' ages from 18-45 years old Participants who are referred to the post-COVID clinics Participants who are discharged from the hospitals within 3 to 6 months ago. Exclusion Criteria: If they have any active infection such as pneumonia, cardiovascular instability, pulmonary embolism, and disability or disorders. Musculoskeletal disorders Neurodegenerative diseases Patients unable to walk.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asma A Alonazi, DSc
    Phone
    +966554447464
    Email
    a.alonazi@mu.edu.sa
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdullah K Alisamil, PhD
    Phone
    +1(909) 499-6811
    Email
    aalismail@llu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Asma A Alonazi, DSc
    Organizational Affiliation
    Majmaah University, College of Applied Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No data will be shared with other researchers.

    Learn more about this trial

    Post-Coronavirus Disease of 2019 (COVID-19) Rehabilitation Clinics in Saudi Arabia

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