NCT04837456.
Study name | Metabolic Syndrome and Degenerate Meniscus Tears |
Methods |
Study design: single centre, double‐blind, parallel‐group, four‐arm randomised controlled trial Setting: First Affiliated Hospital of Jinzhou Medical University, China Trial time period: June 2017 to March 2020 Interventions: calorie‐restricted diet and exercise intervention group; libitum diet and waiting list control group; early arthroscopic partial meniscectomy (APM) (syndrome within 3 to 6 months) group or a delayed APM (syndrome more than 6 months) group Sample size calculations: 180 participants Analysis: not reported |
Participants |
Inclusion criteria
Exclusion criteria
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Interventions |
Calorie restricted diet and exercise intervention: A balanced diet that provided an energy deficit of 800 kcal/day from their daily energy requirement. Macronutrient content of low caloric diet, expressed as percentage of ingested energy with carbohydrates 45‐65%; fat 20‐35%; and protein 10‐35%. Each session was approximately 150 minutes one week for six months and consisted of aerobic exercises, resistance training, and exercises to improve flexibility and balance. Libitum diet and waiting list control group: participants then underwent a calorie of 2000 calorie above based on libitum free diets recommended to adults and normal physical activity without exercise during the program. Early APM group: Early APM group participants received APM with symptoms within 3 to 6 months. Delayed APM group: Delayed APM group recruit participants with symptoms lasting for more than 6 months. |
Outcomes |
Primary outcomes Knee KOOS 4 WOMAC International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form The WOMET score Kellgren‐Lawrence grade BMI Lysholm knee score Blood tests |
Starting date | 1 June 2017 |
Contact information | Hongyu Wang, chief resident, The First People's Hospital of Jingzhou |
Notes |
Clinical trial registration:NCT04837456 Trial status: recruitment completed Expected completion date: 1 March 2021 |