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The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial.
Trials. 2017 06 17; 18(1):282.T

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 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.

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.

Authors+Show Affiliations

Department of Chiropractic, Macquarie University, North Ryde, Sydney, NSW, 2109, Australia. roger.engel@mq.edu.au.Department of Chiropractic, Macquarie University, North Ryde, Sydney, NSW, 2109, Australia.Southcare, Sutherland Hospital, Sydney, Australia.Department of Chiropractic, Macquarie University, North Ryde, Sydney, NSW, 2109, Australia.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28623944

Citation

Engel, Roger M., et al. "The Effect of Combining Manual Therapy With Exercise for Mild Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomised Controlled Trial." Trials, vol. 18, no. 1, 2017, p. 282.
Engel RM, Wearing J, Gonski P, et al. The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. Trials. 2017;18(1):282.
Engel, R. M., Wearing, J., Gonski, P., & Vemulpad, S. (2017). The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. Trials, 18(1), 282. https://doi.org/10.1186/s13063-017-2027-z
Engel RM, et al. The Effect of Combining Manual Therapy With Exercise for Mild Chronic Obstructive Pulmonary Disease: Study Protocol for a Randomised Controlled Trial. Trials. 2017 06 17;18(1):282. PubMed PMID: 28623944.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of combining manual therapy with exercise for mild chronic obstructive pulmonary disease: study protocol for a randomised controlled trial. AU - Engel,Roger M, AU - Wearing,Jaxson, AU - Gonski,Peter, AU - Vemulpad,Subramanyam, Y1 - 2017/06/17/ PY - 2016/11/07/received PY - 2017/05/30/accepted PY - 2017/6/19/entrez PY - 2017/6/19/pubmed PY - 2018/4/3/medline KW - COPD KW - Chronic obstructive pulmonary disease KW - Exercise KW - Lung function KW - Manual therapy KW - Pulmonary rehabilitation KW - Randomised controlled trial KW - Spinal manipulative therapy KW - Trial protocol SP - 282 EP - 282 JF - Trials JO - Trials VL - 18 IS - 1 N2 - 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 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. 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28623944/The_effect_of_combining_manual_therapy_with_exercise_for_mild_chronic_obstructive_pulmonary_disease:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2027-z DB - PRIME DP - Unbound Medicine ER -