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Effects of Otago Exercise Program vs Circuit Training on Balance in Chronic Obstructive Pulmonary Disease Patients (COPD)

2022年1月24日 更新者:Riphah International University

Effects of Otago Exercise Program vs Circuit Training on Balance in Chronic Obstructive Pulmonary Disease (COPD) Patients

The study is designed to compare circuit training and otago exercise program for improvement of balance in COPD patients. Although both techniques are effective for balance training but Otago exercise program is home-based exercise program, which, if proven effective, will help the COPD patients to do work up at home, thereby reducing cost of hospital visits and improving balance ability and thus the quality of life more effectively.

研究概览

详细说明

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that result in progressive restriction of airflow and respiratory distress and is the 4th leading cause of death. In specific, it happens among smokers over the age of 40 and individuals exposed to biomass smoke. The prevalence of COPD is expected to increase as the population ages. Pakistan is a lower-middle-income country, and facing a high burden of chronic obstructive pulmonary diseases. The prevalence of COPD among Pakistani adults aged more than 40 years is 2.1% In addition to pulmonary symptoms, patients with chronic obstructive pulmonary disease develop many other manifestations of the disease, such as cardiovascular co morbidities, peripheral muscle dysfunction, weight loss, systemic inflammation, and psychological problems. People also have reduced capacity for exercise and functional mobility. Among all, one important extra respiratory manifestation is impaired balance. It is a frequent problem in stable COPD and increases with the severity of the disease. As in COPD there is loss of body cells which causes skeletal muscle weakness and balance impairment.

Since skeletal muscle dysfunction in people with COPD is a commonly identified impairment, it is not surprising that lower-limb muscle weakness has also been linked in this population to balance deficits and increased risk of falling. Muscle strength in both the upper and lower extremities is reduced in COPD patients along with impairments in exercise tolerance.

Pulmonary rehabilitation (PR) is an effective COPD intervention that involves exercise training and psychosocial support, and patient education to achieve maximum community independence and function. This recommended standard of care, however, focuses primarily on training peripheral muscles through endurance and strength training and does not include a particular training component. The effective intervention to successfully reduce both the rate and risk of falling has been shown to be exercise with balance-specific training.

As COPD decreases the amount of physical activity, even early in the disease phase, and impairs the strength of the lower limb muscle thus affecting balance. Balance training protocols together with pulmonary rehabilitation exercises helps to improve balance and symptoms of COPD. Although both circuit training and Otago exercise program are effective for balance training but Otago exercise program is home-based exercise program, which, if proven effective, will help the COPD patients to do work up at home, thereby reducing cost of hospital visits and improving balance ability and thus the quality of life more effectively.

研究类型

介入性

注册 (实际的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Federal
      • Islamabad、Federal、巴基斯坦、44000
        • Suman Sheraz

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Both male and female patients.
  • Patients with mild / moderate COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
  • Patients with fall history in the past 5 years.

Exclusion Criteria:

  • Oxygen-dependent or mechanically ventilated patients.
  • Patients with impaired hearing or cognition, (e.g., dementia or neurological condition)
  • Patients with limited balance and mobility owing musculoskeletal or neurological condition.
  • Patients with unstable cardiovascular disease.
  • Patients with intellectual disabilities.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Otago exercise group

The Otago exercise group will practice the Otago exercise protocol which includes strength and balance exercises along with pulmonary rehabilitation.

  • 3 times per week for 8 weeks.
  • Each session will be of 60 minutes
  • Total number of sessions: 24
  1. Warm-up exercises. Chair March, Arm swings ( 30 second), Head movement, neck movement, back extension, trunk movement, ankle movement (repeat 5 times).

    Back of thigh stretch, calf stretch, (hold for 8 seconds).

  2. Strengthening exercises Front knee strengthening, back knee strengthening, side hip strengthening (2 or more sets of 10 reps) Calf raises, toe raises (repeat this exercises 10 to 20 times)
  3. Balance improvement exercises Knee bends, heel-toe standing, heel toes walking, one leg stand ( start with 5 sec move up to 10 sec) Side walk, heel walking, sit to stand, backwards walking, heel toes walking backwards, walking and turning around, stair walking (10 steps).
  4. Cool-down session Back of thigh stretch, calf stretches ( 10 to 20 sec hold, 1 to 3 reps)
  5. Pulmonary rehabilitation program

    • Daily breathing exercises (e.g. diaphragmatic, pursed lip breathing).
    • Stretch exercise for major respiratory muscles.
有源比较器:Circuit training group

The Circuit training group will practice balance exercises including Stance exercise, Functional strength exercise, Transition exercise and Gait training along with pulmonary rehabilitation.

  • 3 times per week for 8 weeks.
  • Each session will be of 60 minutes
  • Total number of sessions: 24
  1. Functional strength exercises Heel raise, toe raise, walking on toes, step ups in all directions ( forward, backward and sideways) (2 sets and 8 reps)
  2. Stance exercises Tandem, narrow, one leg stance, and stand on uneven surfaces with open eyes (each exercise 30 seconds) Tandem, narrow, one leg stance, and stand on uneven surfaces with eyes closed (each exercise 15seconds).
  3. Transition exercises Sit to stand from chair with arms (10 reps) and then without arms support (5 reps).

    Sit on floor and stand up with assistance and then without assistance.

  4. Gait training Walking tandem, sideway and backward with arm support. Walking tandem, sideway and backward without arm support Walking tandem, sideway and backward over obstacles
  5. Pulmonary rehabilitation program

    • Daily breathing exercises (e.g. diaphragmatic, pursed lip breathing).
    • Stretch exercise for major respiratory muscles

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Berg Balance Scale
大体时间:8 weeks
Berg Balance Scale was originally developed to measure balance in the elderly, it has since been used to measure balance in a wide variety of patients. Each of these items is scored from 0 to 4, which are summed to make a total score between 0 and 56, with a higher score indicating better balance. The relative intrarater reliability of the Berg Balance Scale is 0.98 (0.97 to 0.99). Relative inter-rater reliability is 0.97 (0.96 to 0.98). Changes in berg balance scale from baseline to 4th and after 8 weeks of intervention will be assessed.
8 weeks
Unipedal Stance (UPST) test
大体时间:8 weeks
The Unipedal stance test is described as a method of quantifying static balance ability and is useful in explaining other variables of importance such as frailty and self-sufficiency in activities of daily living, gait performance, and fall status. It can be used in a variety of settings and requires minimal equipment or training. It is a valid measure. Abnormal unipedal stance test (UPST) time with the eyes open is related to conditions such as peripheral neuropathy and intermittent claudication. Decreased eyes open UPST time is also associated with an increased risk for falls. Its inter-rater reliability was determined to be excellent with an intra-class correlation coefficient of 0.994(95% confidence interval 0.989-0.996) for eye open and 0.998 (95% confidence interval 0.996-0.999) for eye close. Average time of unipedal stance in healthy older adults is < 10 seconds. Changes in UPST from baseline to 4th and after 8 weeks of intervention will be assessed.
8 weeks

次要结果测量

结果测量
措施说明
大体时间
St. George Respiratory questionnaire for quality of life (QOL)
大体时间:8 weeks

The most commonly used disease-specific quality of life measure for COPD patients is the St. George's Respiratory Questionnaire (SGRQ). Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.. It is divided in two parts. Part I produces the Symptoms score, and Part 2 the Activity and Impacts scores. The reliability coefficient was 0.94 for the overall scale and 0.72 for "Symptoms", 0.89 for "Activity", and 0.89 for "Impacts" subscales.

A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment) Changes in St. George Respiratory questionnaire for quality of life from baseline to 4th and after 8 weeks of intervention will be assessed.

8 weeks
Peak expiratory flow rate (PEFR)
大体时间:8 weeks
Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings. Changes in PEFR from baseline to 4th and after 8 weeks of intervention will be assessed.
8 weeks
Forced vital capacity (FVC)
大体时间:8 weeks
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal. Changes in FVC from baseline to 4th and after 8 weeks of intervention will be assessed.
8 weeks
Forced expiratory volume in 1sec (FEV1)
大体时间:8 weeks
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal. Changes in FEV1 from baseline to 4th and after 8 weeks of intervention will be assessed.
8 weeks
FVC/FEV1
大体时间:8 weeks
FVC/FEV1 measured through digital spirometer. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65). Changes in FEV1/FVC from baseline to 4th and after 8 weeks of intervention will be assessed.
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月10日

初级完成 (实际的)

2021年12月20日

研究完成 (实际的)

2022年1月18日

研究注册日期

首次提交

2021年9月1日

首先提交符合 QC 标准的

2021年9月13日

首次发布 (实际的)

2021年9月16日

研究记录更新

最后更新发布 (实际的)

2022年1月26日

上次提交的符合 QC 标准的更新

2022年1月24日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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