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ICIAM Rehabilitation Program Study: A Randomized Controlled Trial
Sponsor: China-Japan Friendship Hospital
Summary
Immunotherapy has become a cornerstone in oncology; however, managing its associated adverse events poses a significant clinical challenge. Cardiotoxicity represents a major concern, among which myocarditis accounts for a considerable proportion. This condition is characterized by poor prognosis, highly heterogeneous outcomes, and a high prevalence of persistent cardiac dysfunction after the acute phase. The dual impact of myocardial injury and underlying malignancy severely compromises patients' quality of life. Currently, it remains unclear whether implementing rehabilitation strategies for this patient population can mitigate the aforementioned challenges. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of a structured rehabilitation program for convalescent patients with ICIAM.
Official title: A Study on Rehabilitation Study for Immune Checkpoint Inhibitors-Associated Myocarditis: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-01-01
Completion Date
2028-07-31
Last Updated
2025-12-12
Healthy Volunteers
No
Interventions
rehabilitation protocol
The intervention protocol comprised a pharmacological component (Shengxian Quyu therapy) and a traditional Chinese exercise rehabilitation component.The traditional Chinese exercise rehabilitation protocol is designed following the FITT (Frequency, Intensity, Time, Type) principles of exercise therapy. Exercise modalities may include Baduanjin, with specific frequency, duration, and intensity tailored to each participant's actual condition.