{Reference Type}: Clinical Trial Protocol
{Title}: Comparing effectiveness of physiotherapy versus drug management on fatigue, physical functioning, and episodic disability for myalgic encephalomyelitis in post-COVID-19 condition: a study protocol of randomized control trial.
{Author}: Sarker AH;Hossain KMA;Kabir MF;Jahan S;Hossain MZ;Hossain T;Jahid IK;
{Journal}: Trials
{Volume}: 25
{Issue}: 1
{Year}: 2024 May 15
{Factor}: 2.728
{DOI}: 10.1186/s13063-024-08077-x
{Abstract}: <B>BACKGROUND: </B>Physiotherapy interventions effectively improved fatigue and physical functioning in non-COVID patients with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). There is a research gap on the effectiveness of physiotherapy interventions versus drug management on ME/CFS in post-COVID-19 conditions (PCC).<BR><B>METHODS: </B>We planned a three-arm prospective randomized control trial on 135 PCC cases with ME/CFS who are diagnosed between 20 November 2023 and 20 May 2024 from a population-based cohort. The study aims to determine the effectiveness of physiotherapy interventions as adapted physical activity and therapeutic exercise (APTE) provided in institution-based care versus telemedicine compared with drug management (DM). Participants will be assigned to three groups with the concealed location process and block randomization with an enrollment ratio of 1:1:1. The post-treatment evaluation will be employed after 2 months of interventions, and follow-up will be taken after 6 months post-intervention. The Chalder fatigue scale will measure the primary outcome of fatigue. SF-36 and the disability-adjusted life years (DALYs) will measure the secondary outcome of physical functioning and episodic disability.<BR><B>CONCLUSIONS: </B>This study will address the research gap to determine the appropriate approach of physiotherapy or drug management for ME/CFS in PCC cases. The future direction of the study will contribute to developing evidence-based practice in post-COVID-19 condition rehabilitation.<BR><B>BACKGROUND: </B>The trial is registered prospectively from a primary Clinical Trial Registry side of WHO CTRI/2024/01/061987. Registered on 29 January 2024.