Clinical trial NCT05092178: Calorie Restricted Diet and Exercise
Official title: Effect of Calorie-restricted Diet and Exercise Intervention vs Exercise on the Knee Function of Metabolic Syndrome Patients With Degenerate Meniscus Lesions, a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: The First People's Hospital of Jingzhou
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 86
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Calorie-restricted(CR) diet and exercise were effective to reduce Metabolic syndrome(MetS), however, its effect on knee functions for MetS patients with degenerate meniscus lesions(DMLs) was still poorly investigated.

Detailed description: The CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement. Total daily energy intake of 1200-2000 kcal/day were based on baseline weight, and for safety, no woman was provided with less than 1100 kcals/d and no man less than 1300 kcals/d. The energy of the intake calorie restricted diet per day was calculated based on the detailed composition of meals, such as rice, vegetables, eggs, pork, and beef, using the Chinese food composition tables. Our diets were cooked with traditional Chinese cooking methods such as boiling, stir-frying, and stewing. During the intervention, other lipid-lowering drugs were not allowed to intake supplement as it alters the outcome. Participants receive education or counseling by a dietitian for modulations of their caloric intake weekly.

The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d/week. Resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d/week, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d/week. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video. Patients who complete at least 80% of diet restriction and exercise were included in analysis. Calorie restricted diet and exercise group contain both the above intervention.

Eligibility criteria: Inclusion Criteria:

* • Must be age between 35 and 70 years old;

  * Clinical diagnosis of metabolic syndrome;

Exclusion Criteria:

* • Must be able to have no acute knee injury such as car crash or acute sports injury;

  * Must be able to have no knee surgeries history;
  * Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
  * Must be able to have no contraindications to MRI;
  * Must be able to have no severe cardiopulmonary disease;
  * Must be able to have no musculoskeletal or neuromuscular impairments ;
  * Must be able to have good visual, hearing, or cognitive;

Primary outcomes:
measure: The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
timeFrame: Change from Baseline KOOS at 6 months
measure: The International Knee Documentation Committee Subjective Knee Evaluation score change
timeFrame: Change from Baseline IKDC at 6 months
measure: The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
timeFrame: Change from Baseline KOOS at 12 months
measure: The International Knee Documentation Committee Subjective Knee Evaluation score change
timeFrame: Change from Baseline IKDC at 12 months
Secondary outcomes:
measure: subscales of KOOS pain score change
timeFrame: Change from Baseline pain at 6 months
measure: subscales of KOOS pain score change
timeFrame: Change from Baseline pain at 12 months
measure: subscales of KOOS symptoms score change
timeFrame: Change from Baseline symptoms at 6 months
measure: subscales of KOOS symptoms score change
timeFrame: Change from Baseline symptoms at 12 months
measure: KOOS activity of daily living change
timeFrame: Change from Baseline activity of daily living at 6 months
measure: KOOS activity of daily living change
timeFrame: Change from Baseline activity of daily living at 12 months
measure: sport and recreational function change
timeFrame: Change from Baseline sport and recreational function at 6 months
measure: sport and recreational function change
timeFrame: Change from Baseline sport and recreational function at 12 months
measure: knee related quality of life change
timeFrame: Change from Baseline knee related quality of life at 6 months
measure: knee related quality of life change
timeFrame: Change from Baseline knee related quality of life at 12 months
measure: systolic blood pressure change
timeFrame: Change from Baseline systolic blood pressure at 6 months
measure: systolic blood pressure change
timeFrame: Change from Baseline systolic blood pressure at 12 months
measure: diastolic blood pressure change
timeFrame: Change from Baseline diastolic blood pressure at 6 months
measure: diastolic blood pressure change
timeFrame: Change from Baseline diastolic blood pressure at 12 months
measure: body mass index change
timeFrame: Change from Baseline body mass index at 6 months
measure: body mass index change
timeFrame: Change from Baseline body mass index at 12 months
measure: weight change
timeFrame: Change from Baseline weight at 6 months
measure: weight change
timeFrame: Change from Baseline weight at 12 months
measure: high-density lipoprotein cholesterol change
timeFrame: Change from Baseline high-density lipoprotein cholesterol at 6 months
measure: high-density lipoprotein cholesterol change
timeFrame: Change from Baseline high-density lipoprotein cholesterol at 12 months
measure: low-density lipoprotein cholesterol change
timeFrame: Change from Baseline low-density lipoprotein cholesterol at 6 months
measure: low-density lipoprotein cholesterol change
timeFrame: Change from Baseline low-density lipoprotein cholesterol at 12 months
measure: triglycerides change
timeFrame: Change from Baseline triglycerides at 6 months
measure: triglycerides change
timeFrame: Change from Baseline triglycerides at 12 months
measure: total cholesterol change
timeFrame: Change from Baseline total cholesterol at 6 months
measure: total cholesterol change
timeFrame: Change from Baseline total cholesterol at 12 months
measure: fast blood glucose change
timeFrame: Change from Baseline fast blood glucose at 6 months
measure: fast blood glucose change
timeFrame: Change from Baseline fast blood glucose at 12 months
measure: waist circumstance change
timeFrame: Change from Baseline waist circumstance at 6 months
measure: waist circumstance change
timeFrame: Change from Baseline waist circumstance at 12 months
Other outcomes:
Locations:
city: Jinzhou
country: China
facility: First Affiliated Hospital of Jinzhou Medical University
state: Liaoning
Study officials:
References: