Physiotherapy Intervention in Patients With Persistent COVID-19 Disease Using Aerobic Exercise and Association With Genetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- EuroQoL Quality of Life Scale (EQ5D)
研究概览
简要总结
Aerobic exercise - Nordic walking in Persistent Covid (PC) vs. healthy controls.
The main objective of this study is to analyse the genes associated with increased physical performance in patients with PC vs. healthy controls and to measure the level of lactic acid in blood, pre and post exercise session in patients affected by PC.
Relevance: It is intended to be a tool for patients with CP who have not been hospitalised, nor have been offered outpatient rehabilitation treatment. They have not recovered their work, family, sporting or leisure functions. They have particular problems in returning to aerobic exercise.
We think that they may need to be accompanied in the recovery of their physical condition under the supervision of health professionals. Most of the studies offered to them are exploratory, not intervention. Our proposal is a 12-week intervention.
Our proposal, delves into the mechanisms that may underlie their fatigue and their problems in returning to aerobic exercise, in order to collaborate in approaching possible solutions.
Secondary objectives: To study in each of the patients with persistent covid, included in the aerobic Nordic walking programme, their DNA in order to, based on two candidate genes, analyse the role of genetic polymorphisms associated with increased VO2 max training, compared to a healthy control group.
To assess the blood lactic acid level pre and post exercise in a group of patients with persistent covid pre and post aerobic Nordic walking programme. Patients and Methods: 33 patients with CP and 33 healthy controls will follow a Nordic walking programme for 12 weeks. QIAGEN Cube automatic extractor and lactic acid meter will be used.
详细描述
Design: Parallel non-randomized clinical trial. Study arms: Experimental group with Nordic walking programme (n=15) and healthy control group with the same programme (n=15).
Patients will be recruited by means of a mass mailing to their addresses in the Covid Persistente Madrid group. Participants must meet the inclusion criteria and sign the informed consent form. Patients will be asked to submit a recent basic blood test and an electrocardiogram if available.
Medical Rehabilitation Consultation for screening of patients It is assumed that the patient has already been diagnosed with longCOVID, so he/she should provide data from previous clinical history in relation to the process: time of evolution, characteristics of the syndrome, and treatments carried out.....
It is essential that the patient provides a recent blood test. Objectives To ascertain the main symptomatology presented by the patient, with relevance of signs and symptoms that cause functional limitation.
Determine the presence of comorbidities that may be a contraindication or precaution for the practice of the activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent symptoms of covid for more than one year.
- •Age between 30 and 60 years.
- •Complete vaccination schedule (one dose is sufficient, as this was considered by the Ministry for patients who have passed the disease).
- •Recent basic blood test.
排除标准
- •Presence of comorbidities of musculoskeletal origin that contraindicate the practice of the proposed exercise.
- •Presence of uncontrolled cardiac or respiratory disease.
- •Presence of incapacitating neurological disease that significantly interferes with the proposed exercise activity Severe anaemia or other co-morbidities that significantly interfere with the proposed exercise activity
- •Diagnosis or symptoms of dysautonomia
- •Presence of high rates of fatigue
- •Desaturations during the exercise test that imply a need for oxygen supply for exercise
- •Desaturation on exertion during exercise ≥3%.
结局指标
主要结局
EuroQoL Quality of Life Scale (EQ5D)
时间窗: Changes from baseline and at the end of procedure (12 weeks)
The EuroQoL Quality of Life Scale (EQ5D) is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable). The score from Part II can be used to track changes in health, on an individual or group level, over time
36-Item Short Form Survey (SF-36)
时间窗: Changes from baseline and at the end of procedure (12 weeks)
The 36-Item Short Form Survey (SF-36) is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. SF-36 scale is directly transformed into a 0-100 on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Lactic acid concentration
时间窗: Changes from baseline and at the end of procedure (12 weeks)
A small blood sample (0.3 microlitres) will be taken from the participant, by puncturing the index finger of the hand, to perform a blood lactate analysis. Pre-exercise and immediately after the physical activity
Modified Fatigue Impact Scale (MFIS)
时间窗: Changes from baseline and at the end of procedure (12 weeks)
The Modified Fatigue Impact Scale (MFIS) is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives.The total score of the MFIS ranges from 0 to 84. The ranges of scores for each subscale are as follows: physical, 0 to 36; cognitive, 0 to 40; and psychosocial, 0 to 8. A higher score means fatigue is more significantly affecting patient´s life.
次要结局
- Genotype frequency of ACTN3 polymorphism(Baseline)
- Genotype frequency of CKM polymorphism(Baseline)
- Genotype frequency of AMPD1 polymorphism(Baseline)
- Genotype frequency of MLCK c.49C>T polymorphism(Baseline)
- Genotype frequency of ACE2 rs6629110 polymorphism(Baseline)
- Genotype frequency of ACE polymorphism(Baseline)
- Genotype frequency of ACE2 rs2106806 polymorphism(Baseline)
- Genotype frequency of MLCK c.37885C>A polymorphism(Baseline)