FatigueNCT05799534
Post-Coronavirus Disease of 2019 (COVID-19) Rehabilitation Clinics in Saudi Arabia
A study testing Physical Therapy Rehabilitation in people with Fatigue and Cardiopulmonary Arrest, run by Majmaah University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Cardiopulmonary Arrest, Physical Inactivity
- What is being tested?
- Physical Therapy Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post-COVID-19 Rehabilitation Clinics in Saudi Arabia: Improves Physical Status, Dyspnea, Fatigue, Anxiety, and Quality of Life
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.
Read more
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.
Read the 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
- Conditions
- Fatigue, Cardiopulmonary Arrest, Physical Inactivity, Muscle Weakness, Stress, Emotional, Dyspnea
- Being tested
- Physical Therapy Rehabilitation
- Keywords
- Rehabilitation, Coronavirus disease, Respiratory function, 6-min walk test, Physical Therapy
- Medical subject headings
- Fatigue, Heart Arrest, Sedentary Behavior, Muscle Weakness, Stress, Psychological, Dyspnea, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation | Experimental | The duration for 4-week, three sessions per week. Each session will last for 45-60 minutes Receives: Other: Physical Therapy Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 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.
Measured: Less 1 minute
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.
Measured: 1 minute
Secondary outcomes (1)
10-meter walk test (10MWT)
Measure used to assess walking speed in meters per second over a short distance of 14-meters.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after intervention program
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Majmaah University
- Sponsor type
- University, hospital or other
- Collaborators
- King Fahad Medical City
- Responsible party
- Principal investigator, Asma Alonazi, Majmaah University
- Investigators
- Asma A Alonazi, DSc, Principal investigator, Majmaah University, College of Applied Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799534
- Sponsor's protocol ID
- 22-472E
- Status last verified
- Apr 2023
- First submitted
- 4 Apr 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-COVID-19 Rehabilitation Clinics in Saudi Arabia: Improves Physical Status, Dyspnea, Fatigue, Anxiety, and Quality of Life
- ClinicalTrials.gov ID
- NCT05799534
- Acronym / sponsor ID
- 22-472E
- Conditions
- Fatigue, Cardiopulmonary Arrest, Physical Inactivity, Muscle Weakness, Stress, Emotional, Dyspnea
- Keywords
- Rehabilitation, Coronavirus disease, Respiratory function, 6-min walk test, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Majmaah UniversityUniversity, hospital or other
- Collaborators
- King Fahad Medical City
- Study start
- May 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after intervention program
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation | Experimental | Other: Physical Therapy RehabilitationThe duration for 4-week, three sessions per week. Each session will last for 45-60 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy RehabilitationPhysical 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. | Other | Rehabilitation |
Primary outcome
6-min walk test (6-MWT)
Time frame: 6 minutes
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
Time frame: Less 1 minute
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)
Time frame: 1 minute
To stand up and sit down on a chair without arm rests as many times as possible within 1 min.
1 secondary outcome
10-meter walk test (10MWT)
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No. No data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma A Alonazi, DSc principal investigator
Majmaah University, College of Applied Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy Rehabilitation in people with Fatigue and Cardiopulmonary Arrest, run by Majmaah University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asma A Alonazi, DSc (+966554447464, a.alonazi@mu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-min walk test (6-MWT) (time frame: 6 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.