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Completed

NCT Number: NCT05092178

Calorie Restricted Diet and Exercise

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

calorie restricted diet and exercise

Behavioral

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.

exercise alone

Behavioral

In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program.

Primary outcomes

  1. The Knee injury and Osteoarthritis Outcome Score (KOOS) score change

    Time frame: 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)

  2. The International Knee Documentation Committee Subjective Knee Evaluation score change

    Time frame: 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.

  3. The Knee injury and Osteoarthritis Outcome Score (KOOS) score change

    Time frame: Change 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)

  4. The International Knee Documentation Committee Subjective Knee Evaluation score change

    Time frame: Change 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.

Secondary outcomes

  1. subscales of KOOS pain score change

    Time frame: 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.

  2. subscales of KOOS pain score change

    Time frame: Change 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.

  3. subscales of KOOS symptoms score change

    Time frame: 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.

  4. subscales of KOOS symptoms score change

    Time frame: Change 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.

  5. KOOS activity of daily living change

    Time frame: 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.

  6. KOOS activity of daily living change

    Time frame: Change 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.

  7. sport and recreational function change

    Time frame: 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.

  8. sport and recreational function change

    Time frame: Change 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.

  9. knee related quality of life change

    Time frame: 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.

  10. knee related quality of life change

    Time frame: Change 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.

  11. systolic blood pressure change

    Time frame: Change from Baseline systolic blood pressure at 6 months

    systolic blood pressure /mmHg

  12. systolic blood pressure change

    Time frame: Change from Baseline systolic blood pressure at 12 months

    systolic blood pressure /mmHg

  13. diastolic blood pressure change

    Time frame: Change from Baseline diastolic blood pressure at 6 months

    diastolic blood pressure/mmHg

  14. diastolic blood pressure change

    Time frame: Change from Baseline diastolic blood pressure at 12 months

    diastolic blood pressure/mmHg

  15. body mass index change

    Time frame: Change from Baseline body mass index at 6 months

    body mass index /kg/㎡

  16. body mass index change

    Time frame: Change from Baseline body mass index at 12 months

    body mass index /kg/㎡

  17. weight change

    Time frame: Change from Baseline weight at 6 months

    Weight-kg

  18. weight change

    Time frame: Change from Baseline weight at 12 months

    Weight-kg

  19. high-density lipoprotein cholesterol change

    Time frame: Change from Baseline high-density lipoprotein cholesterol at 6 months

    high-density lipoprotein cholesterol (mmol/L)

  20. high-density lipoprotein cholesterol change

    Time frame: Change from Baseline high-density lipoprotein cholesterol at 12 months

    high-density lipoprotein cholesterol (mmol/L)

  21. low-density lipoprotein cholesterol change

    Time frame: Change from Baseline low-density lipoprotein cholesterol at 6 months

    low-density lipoprotein cholesterol (mmol/L)

  22. low-density lipoprotein cholesterol change

    Time frame: Change from Baseline low-density lipoprotein cholesterol at 12 months

    low-density lipoprotein cholesterol (mmol/L)

  23. triglycerides change

    Time frame: Change from Baseline triglycerides at 6 months

    triglycerides (mmol/l)

  24. triglycerides change

    Time frame: Change from Baseline triglycerides at 12 months

    triglycerides (mmol/l)

  25. total cholesterol change

    Time frame: Change from Baseline total cholesterol at 6 months

    total cholesterol (mmol/L)

  26. total cholesterol change

    Time frame: Change from Baseline total cholesterol at 12 months

    total cholesterol (mmol/L)

  27. fast blood glucose change

    Time frame: Change from Baseline fast blood glucose at 6 months

    fast blood glucose (mmol/L)

  28. fast blood glucose change

    Time frame: Change from Baseline fast blood glucose at 12 months

    fast blood glucose (mmol/L)

  29. waist circumstance change

    Time frame: Change from Baseline waist circumstance at 6 months

    waist circumstance (cm)

  30. waist circumstance change

    Time frame: Change from Baseline waist circumstance at 12 months

    waist circumstance (cm)

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Jingzhou

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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