Metabolic Syndrome
Conditions
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.
Interventions
BEHAVIORALcalorie restricted diet and exercise
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.The exercise intervention consists of aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for≥2 d•wk for six months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d•wk, while, resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d•wk, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d•wk. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video.
BEHAVIORALexercise alone
In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program.
Sponsors
The First People's Hospital of Jingzhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Knee injury and Osteoarthritis Outcome Score (KOOS) score change | Change from Baseline KOOS at 6 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) |
| The International Knee Documentation Committee Subjective Knee Evaluation score change | Change from Baseline IKDC at 6 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS activity of daily living change | Change from Baseline activity of daily living at 6 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 change | Change from Baseline sport and recreational function at 6 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 change | Change from Baseline knee related quality of life at 6 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. |
| systolic blood pressure change | Change from Baseline systolic blood pressure at 6 months | systolic blood pressure /mmHg |
| diastolic blood pressure change | Change from Baseline diastolic blood pressure at 6 months | diastolic blood pressure/mmHg |
| body mass index change | Change from Baseline body mass index at 6 months | body mass index /kg/㎡ |
| subscales of KOOS pain score change | Change from Baseline pain at 6 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. |
| high-density lipoprotein cholesterol change | Change from Baseline high-density lipoprotein cholesterol at 6 months | high-density lipoprotein cholesterol (mmol/L) |
| low-density lipoprotein cholesterol change | Change from Baseline low-density lipoprotein cholesterol at 6 months | low-density lipoprotein cholesterol (mmol/L) |
| triglycerides change | Change from Baseline triglycerides at 6 months | triglycerides (mmol/l) |
| total cholesterol change | Change from Baseline total cholesterol at 6 months | total cholesterol (mmol/L) |
| fast blood glucose change | Change from Baseline fast blood glucose at 6 months | fast blood glucose (mmol/L) |
| waist circumstance change | Change from Baseline waist circumstance at 6 months | waist circumstance (cm) |
| weight change | Change from Baseline weight at 6 months | Weight-kg |
| subscales of KOOS symptoms score change | Change from Baseline symptoms at 6 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. |
Countries
China
Outcome results
None listed