Pulmonary Daoyin as a traditional Chinese medicine rehabilitation programme for patients with IPF: A randomized controlled trial

Abstract

Background and objective: IPF is a chronic progressive lung disease in which PR provides benefit for patients. PD, a TCM PR programme, has known effectiveness in COPD, but its utility in IPF is unknown. We investigated its effectiveness and safety in patients with IPF.

Methods: A 6-month randomized controlled trial (RCT) was conducted in three Chinese clinics. Ninety-six participants diagnosed with IPF were randomly assigned to one of the three groups: the PD group received a PD programme two times a day, 5 days/week for 2 months, and the exercise group exercised via a stationary cycle ergometer, 30 min/day, 5 days/week for 2 months. Volunteers in the control group were advised to maintain their usual activities. Primary outcomes were changes from baseline in the 6MWD and HRQoL score on the SGRQ-I at 1 and 2 months (at the end of the intervention) and at 6 months (4 months after the intervention). Secondary outcomes measures included FVC, DL_CO (% predicted) and the changes in mMRC.

Results: The 6MWD was increased in the PD group compared to exercise and control groups. 6MWD increased by 60.44 m in the PD group, 32.16 m in the exercise group and 12.42 m in controls after the 2 months of rehabilitation programme. The between-group differences in the change from baseline were 28.78 m (95% CI: 0.54 to 56.01; P = 0.044) and 48.02 m (95% CI: 23.04 to 73.00; P < 0.001) at 2 months, and 25.61 m (95% CI: -0.67 to 51.89; P = 0.058) and 50.93 m (95% CI: 25.47 to 76.40; P < 0.001) at 6 months, respectively, including a difference exceeding the MCID. There was no significant change in the SGRQ-I score, the mMRC dyspnoea score, FVC and DL_CO (% predicted) in either the PD or exercise groups.

Conclusion: Two months after the intervention, a clinically meaningful difference in 6MWD was observed favouring the PD programme. The PD programme is safe and effective as a rehabilitation intervention designed to increase exercise tolerance and is an appropriate substitute for PR.

Keywords: 6-min walking distance; Daoyin; idiopathic pulmonary fibrosis; pulmonary rehabilitation; traditional Chinese medicine.

Figure 1

Study flow chart to track participants through randomized controlled trial. AE‐IPF, acute exacerbation of idiopathic pulmonary fibrosis; ITT, intention‐to‐treat; PD, pulmonary Daoyin.

Figure 2

6MWD, mMRC, FVC and DL_CO (% predicted) outcomes over time and changes from baseline during the study. Results of the 6MWD, mMRC, FVC and DL_CO (% predicted) over time during the study (A, C, E and G), and changes from baseline in the 6MWD, mMRC, FVC and DL_CO (% predicted) of the study groups (B, D, F and H). (A, C, E and G) , PD; , exercise; , control. (B, D) , T₁ − T₀; , T₂ − T₀; , T₆ − T₀. (F, H) , T₂ − T₀. 6MWD, 6‐min walking distance; DL_CO, diffusing capacity of the lung for carbon monoxide; FVC, forced vital capacity; mMRC, modified British Medical Research Council; PD, pulmonary Daoyin; T₁ − T₀, changes at the first month study endpoint from baseline; T₂ − T₀, changes at the end of the rehabilitation study endpoint from baseline. T₆ − T₀, changes at the end of the follow‐up study endpoint from baseline.

Figure 3

Symptoms, activity, impact and total of SGRQ‐I module over time during the study. , PD; , exercise; , control. PD, pulmonary Daoyin; SGRQ‐I, St George's Respiratory Questionnaire for IPF.