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临床试验/NCT05799534
NCT05799534尚未招募不适用

Post-COVID-19 Rehabilitation Clinics in Saudi Arabia: Improves Physical Status, Dyspnea, Fatigue, Anxiety, and Quality of Life

Majmaah University0 个研究点目标入组 400 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
6-min walk test (6-MWT)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

6-min walk test (6-MWT)

时间窗: 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

时间窗: 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)

时间窗: 1 minute

To stand up and sit down on a chair without arm rests as many times as possible within 1 min.

次要结局

  • 10-meter walk test (10MWT)(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asma Alonazi

Associate Professor

Majmaah University

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