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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Circuit training; Other: Otago Exercise training

• Registration Number: NCT05044884
• Lead Sponsor: Riphah International University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-09-01
• Study Start: 2021-09-10
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-16
• Primary Completion: 2021-12-20
• Status Verified: 2022-01
• Study Completion: 2022-01-18
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Circuit training group	Circuit training	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
Otago exercise group	Otago Exercise training	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

Primary Outcome Measures

Name	Time	Method
Unipedal Stance (UPST) test	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.
Berg Balance Scale	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.

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1sec (FEV1)	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.
FVC/FEV1	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.
St. George Respiratory questionnaire for quality of life (QOL)	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.
Peak expiratory flow rate (PEFR)	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.
Forced vital capacity (FVC)	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.

Trial Locations

Locations (1)

Suman Sheraz; 🇵🇰 Islamabad, Federal, Pakistan