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临床试验/NCT05539547
NCT05539547尚未招募早期 1 期

Effect of Neuromuscular Electrical Nerve Stimulation on Quadriceps Muscle Strength and Endurance in Patients With Chronic Obstructive Pulmonary Disease

Randall Debattista0 个研究点目标入组 140 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
尚未招募
发起方
入组人数
140
主要终点
Change in Quadriceps Strength

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition that results in a mixture of small airway disease and parenchymal destruction, changes that are characteristic of emphysema. COPD is also characterized by persistent airflow limitation, an aspect which is noted to be a major cause of morbidity and disease burden worldwide. One in every 8 patients who suffer an exacerbation requires to be admitted to the hospital. Due to repercussions that arise both because of the systemic effects of COPD and also the aggravating factors due to the exacerbation, new adjuncts to treatment are being researched. NMES is a non-invasive and non-addictive means of muscle contraction and was introduced as a rehabilitation means post muscle injury, surgery, and eventually in certain diseases and its use in the treatment of patients with COPD is being looked into.

This research study shall adopt a quantitative approach. A Randomised Control Trial (RCT) shall be used to investigate the effect of Neuromuscular Electrical Nerve Stimulation on quadriceps muscle strength and endurance. Approximately 103 patients shall be randomly enrolled in the control group and the experimental group. The control group shall receive Physiotherapy as already provided by physiotherapists including chest and mobility exercises. The experimental group shall undergo Physiotherapy with the addition of NMES. To assess the effect of NMES on quadriceps strength and endurance, quadriceps strength shall be tested through the use of a hand-held dynamometer. Endurance shall be tested through a quadriceps endurance test which requires the leg to be extended against a weight corresponding to 70% of the 1 repetition maximum with a pace of 12 movements per minute, a test which will be stopped when the patient can no longer perform the movement despite strong verbal prompting and encouragement and the standardised 1-minute sit-to-stand. All tests are to be conducted before the intervention, hence on admission to the local general hospital and prior discharge to a maximum of 30 days from the date of admission. All tests shall be done in the patients' ward setting. Also, a diagnostic ultrasound scan of this group of muscles shall be performed upon admission and before discharge by a consultant radiologist at the radiology department. The Borg scale shall be used to assess the shortness of breath of the patients following the 1-minute sit-to-stand.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is a respiratory condition that results in a mixture of small airway disease and parenchymal destruction, changes which are characteristic of emphysema. Research showed that COPD is also characterized by persistent airflow limitation, an aspect which some authors noted to be a major cause of morbidity and disease burden worldwide. One in every 8 patients who suffer an exacerbation of COPD requires to be admitted to the hospital. Literature also reported that re-admissions following discharge amounted to more than 20% within the first 20 days and continued to increase to approximately 33% within the first 90 days post-discharge from the hospital. Therefore, given that a high portion of patients will require further hospitalisations, this will impose a financial burden on the health care systems.

It emphasized the fact that apart from the pulmonary changes and respiratory impairments, patients diagnosed with COPD have systemic morphological and biomechanical changes. Morphological changes include a reduction in the cross-sectional area and a reduction in muscle mass. Biochemical changes are primarily due to long-term use of steroids and Chronic Systemic Inflammatory Syndrome (CSIS). Given such changes, more energy is required during activities of daily living (ADLs) by such patients, resulting in shortness of breath (SOB) following minimal exercises.

Due to muscle dysfunction, these patients develop physical deconditioning which is one of the primary symptoms reported. The primary cause of this relates to the ventilatory limitations present.

The severity of the condition and related pathophysiological changes also predict the level of exercise tolerance, with a worse condition resulting in increased levels of muscle atrophy, weakness affecting mostly the lower limbs, and poor oxidative capacity. In 2008, it was noted that the majority of patients with a severe form of COPD were so frail or dyspnoeic, making them unable to tolerate sufficient exercise training intensities required to improve their level of physical activity. Such patients were noted to become dyspnoeic following low-intensity physical activity, resulting in a decreased physical activity to control their SOB, with ultimately one-third of these patients exhibiting quadriceps muscle weakness related to immobility and decreased exercise tolerance.

Deterioration in muscle strength was the most commonly reported symptom characteristic of limb muscle dysfunction in people with COPD. In 2014, Mathur et al. noted that the occurrence of COPD patients experiencing early termination of exercise related to leg fatigue was approximately 40% more common than patients rating of SOB. A further 30% of the population sample reported equal leg fatigue and dyspnoea.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
40 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females between the age of 40 - 79
  • Confirmed diagnosis of an Acute Exacerbation of COPD
  • MRC Dyspnoea score of 4 or above

排除标准

  • Any locomotor or neurological conditions
  • Malignancy or recent history of malignancy
  • Cardiac failure, pacemaker, and implantable cardioverter-defibrillator (ICD)
  • Distal arteriopathy, venous thromboembolism
  • Disabilities or recent orthopedic surgeries

结局指标

主要结局

Change in Quadriceps Strength

时间窗: Week 0 and up to 30 days

hand-held dynamometer shall be used to determine the muscle strength present before and after the intervention of the quadriceps muscle, irrespective of which group the patient is randomly enrolled to. Three readings shall be taken on each leg with the average recorded. Patients will sit at the edge of a bed, with the bed slightly elevated so that the lower limbs were in no time not in contact with the ground provided that the patient has sufficient static sitting balance.

Change in Quadriceps Endurance using the Quadriceps Endurance Testing

时间窗: Week 0 and up to 30 days

2. Quadriceps Endurance test: The quadriceps endurance test is performed with the patient sitting on a chair (White et a., 2013) with the starting position of 90 degrees knee and hip flexion with both arms crossed over the chest. The test consists of extending the dominant leg against weight corresponding to 70% of 1 repetition maximum with a pace of 12 movements per minute until exhaustion. The test shall stop when the participants could no longer follow the movements despite strong verbal prompting and encouragement. The duration is then recorded as the quadriceps endurance limit time (TlimQ, seconds).

次要结局

  • Change in the Dyspnoea Breathlessness scale (Borg Dyspnoea Scale)(Week 0 and up to 30 days)
  • Change in COPD Assessment Test Score (CAT Score)(Week 0 and up to 30 days)
  • Change in 1 Minute Sit-to-stand(Week 0 and up to 30 days)
  • Change in the Medical Research Council (MRC) dyspnoea scale(Week 0 and up to 30 days)
  • Change in quadriceps muscle length and width(Week 0 and up to 30 days)

研究者

发起方
Randall Debattista
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Randall Debattista

Master (By Research) Student

University of Malta

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