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. 2022 Mar 3;2022(3):CD014328. doi: 10.1002/14651858.CD014328

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
  • Age between 35 and 70 years old

  • Clinical diagnosis of metabolic syndrome

  • Clinical diagnosis of 3 grade degeneration meniscus lesions


Exclusion criteria
  • Acute knee injury such as car crash or acute sports injury

  • History of knee surgeries

  • Rheumatoid arthritis or serious knee osteoarthritis with deformity

  • Contraindications to magnetic resonance imaging (MRI)

  • Severe cardiopulmonary disease

  • Musculoskeletal or neuromuscular impairments

  • Poor visual, hearing, or cognitive function

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