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临床试验/NCT05449379
NCT05449379招募中不适用

Evaluation of Influence of Proprietary Physical Training Program on Quality of Life, Physical Endurance, Function of Muscles and Myokines Profile in Patients After COVID-19 Infection.

Medical University of Bialystok2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Physical endurance improvement assessment of 6 MWT distance and outcome of treadmill stress test.

研究概览

简要总结

The aim of the study is to evaluate the influence of 6 week physical training and respiratory rehabilitation performed in outpatients rehabilitation clinic on quality of life, symptoms, physical endurance, mental state, force of respiratory and skeletal muscles and myokines profile in patients after COVID-19 infection.

详细描述

The study of interventional, prospective character will be conducted in Rehabilitation Department of Medical University of Bialystok on total group of 60 participants less than 12 months after COVID-19 (coronavirus disease) infection. In all participants medical anamnesis, physical examination (including chest wall mobility), anthropometric measures, The Short Physical Performance Battery (SPPB), 6-minute walking test (6MWT six minute walking test) and treadmill stress test will be performed.

Medical history will consist of questions regarding course of COVID-19 and its consequences with special emphasis on dyspnea during daily activities in Borg scale and dyspnea in daily living in mMRC scale, coexisting diseases, treatment, lifestyle, etc. Quality of life will be assessed with use of The Short Form (36) Health Survey - SF-36), Post-COVID-19 Functional Status (PCFS] scale and Modified Fatigue Impact Scale (MFIS). Mental status will be evaluated with the use of Beck Depression Inventory (BDI) and Hamilton Depression Scale (HAMD)) Biochemical measures will be performed including, among others, myokines such as BDNF (brain-derived neurotrophic factor), adiponectin, fibroblast growth factor 21 (FGF21), resistin, myonectin and inflammatory markers, such as interleukin 6 ((Il-6), C-reactive protein (CRP).

Fasting venous blood will be collected in 2 tubes each a 10 ml, one dedicated to obtain serum ("on clot"), second with heparin) to perform biochemical analyses, In clinical evaluation measurement of respiratory (inspiratory and expiratory) muscles force with use of device MicroRPM (respiratory pressure meter), hand grip strength with use of hand dynamometer (Jamar) and strength of quadriceps muscles with use of digital dynamometer (AXIS) will be performed. During first visit also ECG (electrocardiogram), six minute walking test and treadmill stress test will be done. All patients will have diaphragm ultrasound with measurement of diaphragm thickness.

Patient will be randomized to the control and interventional groups. Control group will be subjected to the safe protocol of 6 week physical training (aerobic training, resistance training, general improvement training, stretching training and respiratory rehabilitation) adjusted to the clinical state of patients. Additionally patients will be recommended to perform a set of exercises at home under a supervision of physiotherapist.

Patients from interventional group in addition to the training protocol will be subjected to additional resistance respiratory training with the use of respiratory muscle trainer (Philips Respironics Threshold IMT). Control group will have placebo with no resistance set on respiratory muscle trainer (Philips Respironics Threshold IMT). The study will be double blind, patients will be unaware of being assigned to a group and investigators assessing functional state in the next stages of the study will not conduct rehabilitation and will not be aware of the allocation of patients to groups. Physiotherapists conducting rehabilitation will receive detailed, individual guidelines regarding the training parameters of each patient. In addition, both groups will be educated on rules of safe physical activity and how to deal with troublesome symptoms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

The study will be double blind, patients will be unaware of being assigned to a group and investigators assessing functional state in the next stages of the study will not conduct rehabilitation and will not be aware of the allocation of patients to groups.

入排标准

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

入选标准

  • COVID 19 infection confirmed with a positive PCR (polymerase chain reaction) SARS-CoV-2 (Severe Scute Respiratory Syndrome coronavirus type 2) test less than 12 moths prior to intervention
  • more than 14 days from the day of obtaining a positive PCR test result for SARS-CoV-2 or discharge from hospital.
  • mMRC (modified Medical Research Council) score ≥1
  • age >18 years
  • informed consent signed by patient to conduct the study

排除标准

  • severe pulmonary disease (e.g. COPD)
  • the functional state that makes it impossible to carry out the pre-examination and improvement program
  • severe chest pain
  • worsening dyspnea
  • hemoptysis
  • worsening dry cough
  • worsening oedema of extremities
  • myocarditis (less than 6 months from acute phase)

结局指标

主要结局

Physical endurance improvement assessment of 6 MWT distance and outcome of treadmill stress test.

时间窗: 6 months

6-min walk test (6 MWT) is a exercise test that entails measurement of distance walked over a span of 6 minutes by patient good outcome \> 500 m, bad outcome \< 200 m. Treadmill stress test is performed with use of Bruce or ModBruce (modified Bruce) protocol, the outcome is measured in metabolic equivalents (METs) adjusted to the sex and age

Evaluation of quality of life

时间窗: 6 months

Quality of life measurement with SF36 (The Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health.The Optum™ SF-36v2® Health Survey asks 36 questions to measure functional health and wellbeing from the patient's point of view. It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes. The more number of points witness of better quality of life. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years. This bibliography includes studies of hundreds of diseases, conditions and populations, and greatly enhances the ability to interpret SF health survey data in new studies.Range 0-180 points

Force of respiratory muscles

时间窗: 6 months

Measurement of maximal inspiratory and expiratory pressure

次要结局

  • Modified Medical Research Council (mMRC)(6 months)
  • Concentration of resistin(6 months)
  • Spirometry(6 months)
  • Chest wall mobility(6 months)
  • Modified Borg scale(6 months)
  • Concentration of BDNF( brain-derived neurotrophic factor)(6 months)
  • Concentration of adiponectin(6 months)
  • Concentration of fibroblast growth factor 21 (FGF21)(6 months)
  • Concentration of CRP(6 months)
  • Concentration of myonectin(6 months)
  • Handgrip strength(6 months)
  • Weight(6 months)
  • Hamilton Depression Scale (HAMD))(6 months)
  • Post-COVID-19 Functional Status [PCFS] scale. Range 0-4 0- no limitation of daily functioning, 4 severe limitation of daily functioning(6 months)
  • Modified Fatigue Impact Scale (MFIS).(6 months)
  • Diaphragm ultrasound(6 months)
  • Force of quadriceps muscles(6 months)
  • The Short Physical Performance Battery (SPPB)(6 months)
  • Beck Depression Inventory (BDI)(6 months)
  • Concentration of Il-6(6 months)

研究者

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Sponsor

研究点 (2)

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