Impact of Post COVID Physiotherapy and Rehabilitation in Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- Not Applicable
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary outcome of this study will be the pain types and severity, muscle strength, cardio-respiratory functioning between the (3) three groups. Pain types and severity will be measured by the Mcgill pain questionnaire and modified Orebro musculoskeletal index. Muscle strength of the upper limb and lower limb will be measured by hand dynamometer and modified hand dynamometer. The cardio-respiratory function will be measured by six minutes walk test, spirometry.
研究概览
简要总结
**Title:**Impact of Post COVID Physiotherapy and Rehabilitation in Bangladesh
Aims and Objectives
Aim: Aim of this study will be to figure out the impact of physiotherapy & rehabilitation among post-COVID patients.
Objectives:
· To find out the musculoskeletal, neurological, cardiovascular, and respiratory status of the COVID-19 survivors after pre and post-COVID physiotherapy & rehabilitation.
· To evaluate the high-level mobility status among the COVID survivors after pre and post physiotherapy & rehabilitation.
· Assess the quality of life of the COVID survivors before and after the Post COVID Physiotherapy rehabilitation.
· To know the coping strategy to cope with the current situation has been taken by the COVID survivors and coping status after pre and post-COVID physiotherapy & rehabilitation.
· To find out the effectiveness of the educational booklet of post-COVID physiotherapy rehabilitation.
Hypothesis:
Null Hypothesis of this study:
Null Hypothesis ð»0 = ðœ‡1 �’ ðœ‡1 = 0 or ðœ‡1 = ðœ‡2, where the final mean difference is the same that will be meant the impact of Post COVID physiotherapy interventions are not significant upon the problems associated with functional barriers, quality of life.
Alternative Hypothesis of this Study:
Alternative Hypothesis ð»ð›¼ = ðœ‡1 �’ ðœ‡1 ≠0 or ðœ‡1 ≠ðœ‡2, where the final mean difference is not the same that will be meant the impact of Post COVID physiotherapy interventions are significant upon the problems associated with functional barriers, quality of life.
**Study design:**The study will be experimental. It study participants will be allocated into 3 groups. One the group will be the experimental group, another group will be an educational booklet group and the other group will be the control group.
Study Population: Patients who will be previously diagnosed COVID-19 positive in RT-PCR test and recovered from COVID-19 positive status in Bangladesh.
**Study area:**COVID affected patients who will be residents in Bangladesh will be a targeted population in this study. So the whole of Bangladesh will be selected as the study area.
**Sampling technique:**The researcher will use a simple random sampling method to select samples as the sampling technique. Simple random sampling is a method used to cull a smaller sample size from a larger population and use it to research and make generalizations about the larger group. The process is simple its ease of use and its accurate representation of the larger population.
Outcome measurements tools1.Self-structured Socio-demographic information. 2.COVID-19 exposure and symptoms related questionnaire. 3.Cardio-respiratory function information 4.Muscle strength information (will be measured by dynamometer). 5.Modified Barthel index 6.Modified High-level Mobility assessment tool 7.Self-administered Comorbidity Questionnaire 8.Post-COVID-19 Functional Status (PCFS) Scale 9.Brief-Coping scale 10.WHO Quality of Life questionnaire (WHO QoL BREF) 11.The Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) 12.Mcgill Pain Questionnaire
Interventions
The whole study will be consists of(3) three groups. Experimental group, educational booklet group, and controlgroup. The experimental group will be received physiotherapy rehabilitationinterventions by trained physiotherapists. The educational booklet group willreceive an educational booklet that will contain simple home exercise andactivity advice supplied by the researcher. The Control group will receive nophysiotherapy interventions.
This is an experimental study. Physiotherapyinterventions will be categorized into three categories- Musculoskeletal,neurological, and cardio-respiratory. Physiotherapy interventions will beassessed and prescribe by different trained and qualified therapists. Baseline,post-test data, and follow-up data will be collected by the different datacollectors.
a) Musculoskeletal problems-Participants who will complain about musculoskeletal problems after theirrecovery from COVID-19. A majorscreening tool for a musculoskeletal problem is complaining about the pain bythe participants. The secondary complaining is the loss of muscle strength.Interventions will be prescribed by different therapists according to theparticipant’s musculoskeletal complaint. For pain relieving pain, therapistswill demonstrate pain-relieving techniques – Isometric exercises, Ice packs,hot packs, self-mobilization exercises. For loss of muscle strength, therapistswill demonstrate strengthening exercises. Repetitions and frequency of theprescribed exercises will be chosen by therapists according to the necessity ofthe participant severity.
b) Neurological problems- Participantswho will complain about neurological complain. Participants who will complainabout generalized weakness, problems in balance during high mobility activity,muscle wasting, impaired hand dexterity, co-ordination problems will beconsidered in the neurology group. Active assisted, active exercise andresistance exercises will be used to improved coordination, balance, andfunctional capacity. Prescribed exercise frequency and intensity will bedetermined by therapists according to the participants’ complain.
c) Cardio-respiratory problems- Participantswho will complain of cardio-respiratory problems will be included in thisgroup. Participants who will complain shortness of breath, dyspnea, and Chestpain will be included in the cardio-respiratory group. Positioning, Interval trainingexercise, aerobic exercises, active cycle breathing techniques, Buteykobreathing techniques, respiratory strengthening training exercise, andrelaxation techniques will be used to treat cardio-respiratory problems. Doses,frequency, and repetitions will be determined by physiotherapists.
InterventionparametersIntervention parameter will beprescribed by Physiotherapy professionals. All three groups will receive atleast and not more than 1 session per week. Participants from all groups willreceive four (4) Physiotherapy sessions. The first session and final sessionwill be home visiting. And between the first and final sessions, other sessionswill be conducted by video counselling by the Physiotherapists. Usually, thetime per session will be 20 to 30 minutes long.
FollowupAftercollecting the final data, follow-up data will be collected after 6 months.
DataCollection Procedure
Data will be held by face to face interview or byvideo counselling of the COVID-19 survivors.
DataanalysisData will be analyzed by SPSS 22 version andMicrosoft Excel 13. The statistical test will select according to the nature ofthe Data.
DataauditAn external auditor will examine the data and all the data will keep at a datarepository
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients who will be diagnosed COVID-19 positive by RT-PCR test.
- •2.The age range will be above 18 years because usually affected COVID-19 in elderly age and younger age people will affect but not more susceptible.
- •3.Male and female will be same prioritized although more male is more at risk 4.People who are willing to participate.
排除标准
- •1.Patients who will be the severe physical illness that they are unable to communicate with others.
- •2.Patients who are below 18 years old.
结局指标
主要结局
The primary outcome of this study will be the pain types and severity, muscle strength, cardio-respiratory functioning between the (3) three groups. Pain types and severity will be measured by the Mcgill pain questionnaire and modified Orebro musculoskeletal index. Muscle strength of the upper limb and lower limb will be measured by hand dynamometer and modified hand dynamometer. The cardio-respiratory function will be measured by six minutes walk test, spirometry.
时间窗: baseline data pain types, severity, functional status, cardiorespiratory functional status will be collected at first. then after 4 session, post intervention data will be collected. It will take 3 months
次要结局
- The secondary outcome of this study will be functional status, coping strategy, and quality of life of COVID-19 survivors. The functional status will be measured by Post-COVID functional status. The coping strategy will be measured by Brief-coping questionnaire. Quality of life will be measured by the WHO-QoL-brief questionnaire.(Completing 4 session of physiotherapy intervention and final data collection, after 2 months follow up data will be collected to measure secondary outcome.)