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临床试验/NCT03737890
NCT03737890已完成不适用

Comparison of Hold Relax Pectoral Stretch & Inspiratory Muscle Training on Pulmonary Function Among Frail Elderly

Universiti Tunku Abdul Rahman2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change in Forced Vital Capacity (FVC)

研究概览

简要总结

Frailty is a clinical syndrome that alters the structure and function of respiratory system which causes stiffness of thoracic cage and reduces the chest wall compliance in addition of respiratory muscle weakness that can lead to the reduction of pulmonary function. The aim of this study was to compare the effect of inspiratory muscle training (IMT) and hold-relax pectoral stretch on pulmonary function (FVC, FEV1 and FEV1/FVC) among frail elderly

详细描述

Aging leads to the biological and physiological changes in the human body but it is more pronounced in frail elderly. One of the body systems which will undergo changes due to aging is the respiratory system. Respiratory system changes can be in terms of mechanics, muscular and immunological aspects. These changes often lead to respiratory impairment or more often defined as spirometrically airflow limitation or restrictive- pattern. Aging will change the structure of thoracic cage, causing a reduction in chest wall compliance. Moreover, aging disease such as osteoporosis also causes stiffening of the thoracic cage and kyphosis. As a result, the ribcage is unable to expand and contract, causing difficulty in breathing. In addition, atrophy of skeletal muscles leads to increased loss of lean tissue. With the loss of lean tissue in the respiratory muscles, the pulmonary function of an elderly will subsequently be compromised. All these changes decrease the volume of the thoracic cavity and reduce lung volumes which leads to limitation of air flow, decrease of FEV1, FVC and FEV1/FVC as well as increase in residual volume and functional residual capacity. As a result, elderly will tend to have increased work of breathing compared to younger individuals.

Other than that, immunological changes that occur in the elderly increases their risk of getting respiratory tract infection, leading to development of pulmonary disease such as pneumonia. In addition, elderly have higher exposure to second-hand smoke, toxin exposure from the environment which can predispose them to chronic obstructive pulmonary disease leading to dyspnea and alter the pulmonary function. All these changes can have a strong impact on morbidity, mortality and quality of life in elderly.

As a person ages, observable changes can be seen in body composition and body phenotype. These changes will alter the structure and function of the respiratory system. Prevention and intervention programs are necessary to minimize the loss of respiratory function in order to reverse the progression of frailty condition. Exercises such as inspiratory muscle training (IMT) and hold relax pectoral stretch has been found to be helpful in strengthening the breathing muscles and improving pulmonary function respectively. Studies have shown that these two exercises will help in increasing the pulmonary function but till date there is no study which has been carried out to find the effectiveness of these 2 exercises on pulmonary function in frail elderly.

A total of 34 residents from Seavoy Nursing Home were recruited after screening (excluded; bed ridden participants, not able to communicate and give their consent, suffering from a ruptured eardrum or any other condition of the ear, abnormally low perception of dyspnea, presence of cardiac pacemaker, unable to do overhead movement and hyper-mobility of shoulder). Based on the inclusion criteria, the participants needed to be above 60 years of age, currently residing in a care facility, a citizen of Malaysia, ability to understand Malay, English, Mandarin and Cantonese and able to score more than 16 out of 30 in Montreal Cognitive assessment (MoCA). Score of 16 and above on MoCA was to make sure participants were able to follow and understand the instructions given during testing and intervention. This was followed by assessment for frail criteria. At least 3 of the frail criteria; shrinking, weakness, poor endurance, slowness of gait, and low physical activity level needed to be met by participants. Questions such as body weight, height, losing weight, their daily physical activity, their endurance and power status by self reported exhaustion were asked. For shrinking, body weight and height were measured and compared to nursing homes past 1 year record. Participants with unintentional weight loss of 4.5Kgs or more from past 1 year were considered for this study. Weakness criterion was evaluated by checking the grip strength of the dominant hand with cut-off point for different BMI. Besides that, the poor endurance criterion was assessed using two statements of the CES-D scale: "I felt that everything I did was an effort" and "I could not get going" for much or most of the time, when asked. A low physical activity criterion was met if male scored less than 64 and female less than 52 on Physical Activity Scale for the Elderly (PASE). Besides the slow gait speed criterion was met if the participant took more than 10 seconds to walk back and forth over a ten-foot.

After meeting all the inclusion criteria, participants were randomly divided into either into experimental group who did inspiratory muscle training or control group who did hold-relax pectoral stretch. Pulmonary function (FVC, FEV1, FEV1/FVC) were measured by spirometer in sitting upright position. A nose clip was used and participants were instructed to tightly securing the lips around the mouth piece of spirometer. A single trail was run to make sure participants know how to use the spiromter before actual test was conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Above 60 years of age
  • residing in a care facility
  • Able to score more than 16 out of 30 in Montreal Cognitive assessment (MoCA). Score of 16 and above on MoCA was to make sure participants are able to follow and understand the instructions given during testing and intervention.
  • At least 3 of the frail criteria (shrinking, weakness, poor endurance, slowness of gait, and low physical activity level)

排除标准

  • Low cognitive status (MoCA score less than 16)
  • Suffering from a ruptured eardrum or any other condition of the ear
  • Severe exacerbations , abnormally low perception of dyspnoea
  • Presence of cardiac pacemaker
  • Refusal to participate

结局指标

主要结局

Change in Forced Vital Capacity (FVC)

时间窗: At baseline and after 4 weeks of intervention

Change in Forced Expiratory Volume in 1 Second (FEV1)

时间窗: At baseline and after 4 weeks of intervention

Ratio of FVC/FEV1

时间窗: At baseline and after 4 weeks of intervention

次要结局

未报告次要终点

研究者

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

Imtiyaz Ali Mir

Principal Investigator

Universiti Tunku Abdul Rahman

研究点 (2)

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