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

NCT ID: NCT05799534

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2023-07-31

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:

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

Conditions

Fatigue; Cardiopulmonary Arrest; Physical Inactivity; Muscle Weakness; Stress, Emotional; Dyspnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitation

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

Group Type: EXPERIMENTAL

Physical Therapy Rehabilitation

Intervention Type: OTHER

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.

Interventions

Physical Therapy Rehabilitation

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Fahad Medical City

OTHER_GOV

Sponsor Role: collaborator

Majmaah University

OTHER

Sponsor Role: lead

Responsible Party

Asma Alonazi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asma A Alonazi, DSc

Role: PRINCIPAL_INVESTIGATOR

Majmaah University, College of Applied Medical Sciences

Central Contacts

Asma A Alonazi, DSc

Role: CONTACT

a.alonazi@mu.edu.sa

+966554447464

Abdullah K Alisamil, PhD

Role: CONTACT

aalismail@llu.edu

+1(909) 499-6811

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22-472E

Identifier Type: -

Identifier Source: org_study_id