The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial

Abstract

BackgroundChronic obstructive pulmonary disease (COPD) is a major cause of disability and hospital admission. Current management strategies have not been successful in altering the loss of lung function typically seen as the disease progresses. A recent systematic review into the use of spinal manipulative therapy (SMT) in the management of COPD concluded that there was low level evidence to support the view that a combination of SMT and exercise had the potential to improve lung function more than exercise alone in people with moderate to severe COPD.The aim of this study is to investigate whether the combination of exercise and manual therapy (MT) that includes SMT produces sustainable improvements in lung function and exercise capacity in people with mild COPD.Methods/designThe study is a randomised controlled trial of 202 people with stable mild COPD. The cohort will be divided into two equal groups matched at baseline. The first group will receive a standardised exercise program. The second group will receive MT that includes SMT plus the same standardised exercise program. Exercise will be administered a total of 36 times over an 18-week period, while MT will be administered in conjunction with exercise a total of 15 times over a 6-week period. The primary outcome measure is lung function (forced expiratory volume in the 1st second: FEV1 and forced vital capacity: FVC). The secondary outcome measures are the 6-minute walking test (6MWT), quality of life questionnaire (St George’s Respiratory Questionnaire: SGRQ), anxiety and depression levels (Hospital Anxiety and Depression Scale: HADS), frequency of exacerbations, chest wall expansion measurements (tape measurements) and systemic inflammatory biomarker levels. Outcome measurements will be taken by blinded assessors on seven occasions over a 48-week period. Adverse event data will also be gathered at the beginning of each intervention session.DiscussionThis randomised controlled trial is designed to investigate whether the combination of MT and exercise delivers any additional benefits to people with mild COPD compared to exercise alone. The study is designed in response to recommendations from a recent systematic review calling for more research into the effect of MT in the management of COPD.Trial registrationANZCTRN, 12614000766617. Registered on 18 July 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2027-z) contains supplementary material, which is available to authorized users.

Complex physical rehabilitation of patients with chronic obstructive pulmonary disease at a polyclinic stage of treatment

“…Many studies have shown the positive effect of respiratory gymnastics [10,14,17,19] and physical training [1,3,9] on the indicators of external respiration function, namely the increase in forced expiratory volume in 1 second. The results of several randomized controlled studies have revealed that the use of manual therapy with physical training helps to improve physical performance [5,20]. Some papers provide research results related to the application of Nordic walking [2,6,21], which can be a useful practice for normalizing the work of the cardiovascular system.…”

“…Given the active work of the entire body while walking, the respiratory volume of the lungs increases by about 30%. To date, it has been proven that this progressive walking is 46% more effective than normal walking or jogging and contributes to the normalization of vascular tone [5,8]. CG patients passed a distance of 1500-2500 meters per day on a flat terrain, with a breathing rhythm of inhalation in 2-3 steps and exhalation in 5-6 steps.…”

“…According to World Health organization (WHo) forecasts, the incidence of chronic obstructive pulmonary disease (CoPd) in 2020 will take 5 th place in the world among all diseases, and by 2030 CoPd will constitute the 4 th cause of total mortality. The incidence of CoPd continues to grow steadily, and the life expectancy of patients is shortened by an average of 8 years, whereas recently a decrease has been observed in the rate of mortality from myocardial infarction, tuberculosis, and oncological diseases [1][2][3][4][5]. in Ukraine, approximately 3 million people had a diagnosis of CoPd in 2015 [6].…”

Clinical Research in Prehospital Care: Current and Future Challenges

“…Patients in the prehospital setting are often in a state of distress, and may not be able to provide informed consent for research participation [61]. Additionally, there may be situations where informed consent cannot be obtained in a timely manner due to the patient's condition or the urgency of the situation [62]. In such cases, alternative methods of obtaining informed consent, such as deferred or waived consent, may need to be considered [63].…”

Significance of Pulmonary Rehabilitation in Improving Quality of Life for Subjects With COPD

“…Candemir et al 3 evaluated the relationship between the COPD assessment test and improvements after PR and PR efficiency in subjects with COPD. Engel et al 4 designed a randomized controlled trial (RCT) to investigate whether the combination of exercise and manual therapy including spinal manipulative therapy produced sustainable improvements in lung function and exercise capacity in 202 subjects with stable mild COPD.…”