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
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
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
NCT ID
NCT05799534
First Posted
April 4, 2023
Last Updated
April 4, 2023
Sponsor
Majmaah University
Collaborators
King Fahad Medical City
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
We'll reach out to this number within 24 hrs