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Calorie Restricted Diet and Exercise

Not Applicable
Completed
Conditions
Metabolic Syndrome
Registration Number
NCT05092178
Lead Sponsor
The First People's Hospital of Jingzhou
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
86
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;

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The International Knee Documentation Committee Subjective Knee Evaluation score changeChange from Baseline IKDC at 12 months

The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score questionnaire contains 18 items (7 items for symptoms, 1 item for sport activity, 9 items for daily activities, and 1 item for current knee function.) The total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function and 0 is the worst.

The Knee injury and Osteoarthritis Outcome Score (KOOS) score changeChange from Baseline KOOS at 12 months

The Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales including: Pain (9 items); other Symptoms (7 items); Activities of Daily Living (ADL, 17 items); Sport and Recreation function (Sport/Rec, 5 items); and knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)

Secondary Outcome Measures
NameTimeMethod
KOOS activity of daily living changeChange from Baseline activity of daily living at 12 months

Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.

diastolic blood pressure changeChange from Baseline diastolic blood pressure at 12 months

diastolic blood pressure/mmHg

body mass index changeChange from Baseline body mass index at 12 months

body mass index /kg/㎡

triglycerides changeChange from Baseline triglycerides at 12 months

triglycerides (mmol/l)

subscales of KOOS pain score changeChange from Baseline pain at 12 months

Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life.The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.

fast blood glucose changeChange from Baseline fast blood glucose at 12 months

fast blood glucose (mmol/L)

subscales of KOOS symptoms score changeChange from Baseline symptoms at 12 months

Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.

sport and recreational function changeChange from Baseline sport and recreational function at 12 months

Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.

knee related quality of life changeChange from Baseline knee related quality of life at 12 months

Secondary outcomes include five subscales of the KOOS covered pain, symptoms, activity of daily living, sport and recreational function, and knee related quality of life. The minimum is 0 points, the maximum is 4 points. After the score of each part is calculated separately, it is converted into a percentage score by the conversion formula.

weight changeChange from Baseline weight at 12 months

Weight-kg

high-density lipoprotein cholesterol changeChange from Baseline high-density lipoprotein cholesterol at 12 months

high-density lipoprotein cholesterol (mmol/L)

low-density lipoprotein cholesterol changeChange from Baseline low-density lipoprotein cholesterol at 12 months

low-density lipoprotein cholesterol (mmol/L)

total cholesterol changeChange from Baseline total cholesterol at 12 months

total cholesterol (mmol/L)

waist circumstance changeChange from Baseline waist circumstance at 12 months

waist circumstance (cm)

systolic blood pressure changeChange from Baseline systolic blood pressure at 12 months

systolic blood pressure /mmHg

Trial Locations

Locations (1)

First Affiliated Hospital of Jinzhou Medical University

🇨🇳

Jinzhou, Liaoning, China

First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
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