Effects of Tai Chi on the quality of life, mental wellbeing, and physical function of adults with chronic diseases: Protocol for a single-blind, two-armed, randomised controlled trial

Abstract

Introduction Quality of life (QoL), mental wellbeing, and physical function are often diminished among people with chronic disease. Tai Chi is a moderate form of exercise that may be effective in improving chronic disease management. This protocol paper outlines a trial to determine the therapeutic effects of a Tai Chi program on chronic disease management. Methods and analysis This study will be a pilot, interventional, single-blind, two-armed, randomised, parallel, and controlled trial involving a 12-week Tai Chi program for Australian adults. Forty people aged 18 years and older, diagnosed with one or more chronic disease from general community will be recruited. All participants will be randomised to either a 12-week Tai Chi program or a waiting list control group. The Tai Chi program will involve 12 weeks of group Tai Chi sessions, with 45 minutes per session, twice a week. The primary outcome will be QoL as measured by mean scores on the 12-item Short Form Health Survey (SF-12v2) and the EuroQoL (EQ-5D). The secondary outcomes will include anxiety as measured by mean score on the generalised anxiety disorder 7 (GAD-7) survey; depression as measured by mean score on the patient health questionnaire (PHQ-9); work productivity and activity assessment (WPAI:SHP); pain (if any) as measured by mean scores on the visual analogue scale (VAS) and the McGill pain questionnaire (MPQ). These primary and secondary outcomes will be self-administered via two online assessments prior to (T0) and post-intervention (T1). Objective measures as additional secondary outcomes, will also be carried out by the research team including flexibility as measured by the finger to floor distance (FFD); obesity as measured by mean scores on body mass index (BMI); vital signs (blood pressure, heart rate, respiratory rate, temperate, and oxygen saturation) as measured by a blood pressure monitor, tympanic, and pulse oximetry device, and these outcomes will be measured at T0 and T1 in the ECU Holistic Health Research Clinic. People diagnosed with pre-diabetes or diabetes, their glycosylated haemoglobin (HbA1C) and fasting (before breakfast) blood glucose level (BGL) will also be measured via test kits at T0 and T1 in the clinic. Linear mixed modelling will be conducted to assess changes in outcomes. Statistical significance will be set at an alpha level of 0.05 with a medium effect size. All analyses will be conducted using R version 4.1. Qualitative data will be analysed using template thematic analysis. Ethics and dissemination Ethical approval has been obtained from the Edith Cowan University (ECU) Human Research Ethics Committee (2021-03042-WANG). Research findings will be disseminated to the public, health professionals, researchers, and healthcare providers through conference presentations, lay summaries, and peer-reviewed publications. This study will provide an updated evidence on a safe, sustainable, and inexpensive non-pharmacological approach in the management of chronic disease, the number one burden of disease in Australia.