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

NCT05799534 | Unknown DMC

• 1 other identifier: 22-472E
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Rehabilitation; Coronavirus disease; Respiratory function; 6-min walk test; Physical Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 minute

Secondary Outcomes (1)

• 10-meter walk test (10MWT)

  10 minutes

Study Arms (1)

Rehabilitation

EXPERIMENTAL

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

Other: Physical Therapy Rehabilitation

Interventions

Physical Therapy Rehabilitation 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.

Rehabilitation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Majmaah University: lead
• King Fahad Medical City: collaborator

MeSH Terms

Conditions

Fatigue; Heart Arrest; Sedentary Behavior; Muscle Weakness; Stress, Psychological; Dyspnea; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Behavioral Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• Asma A Alonazi, DSc

  Majmaah University, College of Applied Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asma A Alonazi, DSc

CONTACT

+966554447464; a.alonazi@mu.edu.sa

Abdullah K Alisamil, PhD

CONTACT

+1(909) 499-6811; aalismail@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Before and after intervention program

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 5, 2023
• Study Start: May 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share