Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial

Gloria Y Yeh, Peter M Wayne, Daniel Litrownik, David H Roberts, Roger B Davis, Marilyn L Moy, Gloria Y Yeh, Peter M Wayne, Daniel Litrownik, David H Roberts, Roger B Davis, Marilyn L Moy

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a chronic, progressively debilitating condition that is prevalent in the US and worldwide. Patients suffer from progressive dyspnea and exercise intolerance. Physical exercise is beneficial, but conventional pulmonary rehabilitation programs are underutilized. There remains a need for novel interventions that improve symptoms, quality-of-life, and functional capacity. Tai chi is an increasingly popular mind-body exercise that includes physical exercise, breathing training, mindful awareness, and stress management--components that are essential to the self-management of COPD. There are, however, limited data on the effectiveness of tai chi as a therapeutic intervention in this population.

Methods/design: The Primary Aims are to evaluate the efficacy, safety, and feasibility of a 12-week tai chi program for patients with COPD. We utilize a randomized controlled trial design, with participants assigned in a 2:1 ratio to either a group tai chi program (N = 63) or a time/attention-matched education control (N = 31). Our primary outcomes are COPD-specific quality-of-life and exercise capacity. Secondary outcomes include dyspnea, mood, functional status, self-efficacy, and lung function. Cardiopulmonary exercise testing is done in a subset of patients (N = 50). To explore optimal training duration, a subgroup of patients in tai chi are randomly assigned to complete an additional 12 weeks training (total 24 weeks) (Exploratory Aim 1). To explore the impact of a simplified seated intervention including only a subset of tai chi's training components, a third randomly assigned group (N = 31) receives a 12- week mind-body breathing program (N = 31) (Exploratory Aim 2).

Discussion: Results of the BEAM study (Breathing, Education, Awareness, Movement) will provide preliminary evidence regarding the value of tai chi for improving quality of life and exercise capacity in patients with COPD, including information regarding optimal duration. They will also inform the feasibility and potential benefit of an alternative mind-body breathing intervention, and provide insight regarding how isolated mind-body exercise components contribute to the overall effects of tai chi. Should the results be positive, tai chi and related mind-body practices may offer a novel exercise option that is potentially accessible to a large proportion of patients with COPD.

Trial registration: This trial is registered in Clinical Trials.gov, ID number NCT01551953. Date of Registration March 1 2012.

Figures

Figure 1
Figure 1
Conceptual model of tai chi and mind-body breathing and potential mechanistic pathways to improved patient-centered outcomes in chronic obstructive pulmonary disease (COPD). Physical activity, breathing training, and mindful awareness are the key elements of tai chi relevant to COPD. The potential mechanistic pathways through which tai chi may affect outcomes include skeletal muscle conditioning, cardiopulmonary dynamics, pulmonary mechanics, psychosocial factors (mood, self-efficacy, social support), and stress management. Favorable changes in these domains may then impact patient-centered outcomes of quality of life, symptoms, and exercise capacity. The mind-body breathing intervention contains similar key elements, although with less emphasis on physical activity (for example, less aerobic and no lower extremity or core strength training). The BEAM study includes the main patient-centered outcomes as well as secondary measures (quantitative or qualitative assessments) that inform each of the mechanistic pathways depicted in the center oval.
Figure 2
Figure 2
The BEAM study design. The primary aims of this randomized controlled trial are to evaluate the efficacy, safety and feasibility of a 12-week tai chi exercise program as compared to a time- and attention-matched education control. At 12 weeks, subjects in tai chi undergo a second randomization to either continue with tai chi for an additional 12 weeks (total 24 weeks), or to receive usual care. (Exploratory Aim 1: Tai Chi Dosage). To explore the impact of a simplified seated mind-body breathing intervention, a third randomly assigned group receives a 12-week mind-body breathing program (Exploratory Aim 2). After the initial 12 weeks of both education and mind-body breathing, subjects receive usual care for the following 12 weeks. All participants undergo testing at baseline, 12 weeks, and 24 weeks.

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Source: PubMed

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