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

Abstract

Background: Chronic 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/design: The 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 1^st 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.

Discussion: This 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 registration: ANZCTRN, 12614000766617 . Registered on 18 July 2014.

Keywords: COPD; Chronic obstructive pulmonary disease; Exercise; Lung function; Manual therapy; Pulmonary rehabilitation; Randomised controlled trial; Spinal manipulative therapy; Trial protocol.

Fig. 1

Flow of participants through the trial. MT manual therapy, Ex exercise

Fig. 2

SPIRIT figure showing time points for enrolment, interventions and assessments. FEV ₁ Forced expiratory volume in the 1^st second, FVC Forced vital capacity, SGRQ St George’s Respiratory Questionnaire, HAD Hospital Anxiety and Depression (scale), CRP C-reactive protein