Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05799534 |
| Other study ID # |
22-472E |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2023 |
| Est. completion date |
July 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Majmaah University |
| Contact |
Asma A Alonazi, DSc |
| Phone |
+966554447464 |
| Email |
a.alonazi[@]mu.edu.sa |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
Description:
The intervention will include all of the following exercises:
1. 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.
2. 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
3. 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.
4. Home-exercise program (HEP) • All the activities above should continue at home
