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Calorie Restricted Diet and Exercise

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
calorie restricted diet and exercise
exercise alone
Sponsored by
The First People's Hospital of Jingzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • First Affiliated Hospital of Jinzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Calorie restricted diet and exercise intervention

exercise group

Arm 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. The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months.

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

Outcomes

Primary Outcome Measures

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

subscales of KOOS pain score change
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.
subscales of KOOS pain score change
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.
subscales of KOOS symptoms score change
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.
subscales of KOOS symptoms score change
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.
KOOS activity of daily living change
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.
KOOS activity of daily living change
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
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
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
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
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
systolic blood pressure /mmHg
systolic blood pressure change
systolic blood pressure /mmHg
diastolic blood pressure change
diastolic blood pressure/mmHg
diastolic blood pressure change
diastolic blood pressure/mmHg
body mass index change
body mass index /kg/㎡
body mass index change
body mass index /kg/㎡
weight change
Weight-kg
weight change
Weight-kg
high-density lipoprotein cholesterol change
high-density lipoprotein cholesterol (mmol/L)
high-density lipoprotein cholesterol change
high-density lipoprotein cholesterol (mmol/L)
low-density lipoprotein cholesterol change
low-density lipoprotein cholesterol (mmol/L)
low-density lipoprotein cholesterol change
low-density lipoprotein cholesterol (mmol/L)
triglycerides change
triglycerides (mmol/l)
triglycerides change
triglycerides (mmol/l)
total cholesterol change
total cholesterol (mmol/L)
total cholesterol change
total cholesterol (mmol/L)
fast blood glucose change
fast blood glucose (mmol/L)
fast blood glucose change
fast blood glucose (mmol/L)
waist circumstance change
waist circumstance (cm)
waist circumstance change
waist circumstance (cm)

Full Information

First Posted
October 13, 2021
Last Updated
January 15, 2023
Sponsor
The First People's Hospital of Jingzhou
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1. Study Identification

Unique Protocol Identification Number
NCT05092178
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2019 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First People's Hospital of Jingzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calorie restricted diet and exercise intervention
Arm Type
Experimental
Arm 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. The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months.
Arm Title
exercise group
Arm Type
Active Comparator
Arm Description
In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program.
Intervention Type
Behavioral
Intervention Name(s)
calorie restricted diet and exercise
Intervention 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.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.
Intervention Type
Behavioral
Intervention Name(s)
exercise alone
Intervention Description
In exercise alone group, participants then underwent their usual habitual dietary diet and the above exercise intervention during the program.
Primary Outcome Measure Information:
Title
The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
Description
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)
Time Frame
Change from Baseline KOOS at 6 months
Title
The International Knee Documentation Committee Subjective Knee Evaluation score change
Description
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.
Time Frame
Change from Baseline IKDC at 6 months
Title
The Knee injury and Osteoarthritis Outcome Score (KOOS) score change
Description
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)
Time Frame
Change from Baseline KOOS at 12 months
Title
The International Knee Documentation Committee Subjective Knee Evaluation score change
Description
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.
Time Frame
Change from Baseline IKDC at 12 months
Secondary Outcome Measure Information:
Title
subscales of KOOS pain score change
Description
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.
Time Frame
Change from Baseline pain at 6 months
Title
subscales of KOOS pain score change
Description
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.
Time Frame
Change from Baseline pain at 12 months
Title
subscales of KOOS symptoms score change
Description
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.
Time Frame
Change from Baseline symptoms at 6 months
Title
subscales of KOOS symptoms score change
Description
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.
Time Frame
Change from Baseline symptoms at 12 months
Title
KOOS activity of daily living change
Description
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.
Time Frame
Change from Baseline activity of daily living at 6 months
Title
KOOS activity of daily living change
Description
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.
Time Frame
Change from Baseline activity of daily living at 12 months
Title
sport and recreational function change
Description
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.
Time Frame
Change from Baseline sport and recreational function at 6 months
Title
sport and recreational function change
Description
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.
Time Frame
Change from Baseline sport and recreational function at 12 months
Title
knee related quality of life change
Description
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.
Time Frame
Change from Baseline knee related quality of life at 6 months
Title
knee related quality of life change
Description
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.
Time Frame
Change from Baseline knee related quality of life at 12 months
Title
systolic blood pressure change
Description
systolic blood pressure /mmHg
Time Frame
Change from Baseline systolic blood pressure at 6 months
Title
systolic blood pressure change
Description
systolic blood pressure /mmHg
Time Frame
Change from Baseline systolic blood pressure at 12 months
Title
diastolic blood pressure change
Description
diastolic blood pressure/mmHg
Time Frame
Change from Baseline diastolic blood pressure at 6 months
Title
diastolic blood pressure change
Description
diastolic blood pressure/mmHg
Time Frame
Change from Baseline diastolic blood pressure at 12 months
Title
body mass index change
Description
body mass index /kg/㎡
Time Frame
Change from Baseline body mass index at 6 months
Title
body mass index change
Description
body mass index /kg/㎡
Time Frame
Change from Baseline body mass index at 12 months
Title
weight change
Description
Weight-kg
Time Frame
Change from Baseline weight at 6 months
Title
weight change
Description
Weight-kg
Time Frame
Change from Baseline weight at 12 months
Title
high-density lipoprotein cholesterol change
Description
high-density lipoprotein cholesterol (mmol/L)
Time Frame
Change from Baseline high-density lipoprotein cholesterol at 6 months
Title
high-density lipoprotein cholesterol change
Description
high-density lipoprotein cholesterol (mmol/L)
Time Frame
Change from Baseline high-density lipoprotein cholesterol at 12 months
Title
low-density lipoprotein cholesterol change
Description
low-density lipoprotein cholesterol (mmol/L)
Time Frame
Change from Baseline low-density lipoprotein cholesterol at 6 months
Title
low-density lipoprotein cholesterol change
Description
low-density lipoprotein cholesterol (mmol/L)
Time Frame
Change from Baseline low-density lipoprotein cholesterol at 12 months
Title
triglycerides change
Description
triglycerides (mmol/l)
Time Frame
Change from Baseline triglycerides at 6 months
Title
triglycerides change
Description
triglycerides (mmol/l)
Time Frame
Change from Baseline triglycerides at 12 months
Title
total cholesterol change
Description
total cholesterol (mmol/L)
Time Frame
Change from Baseline total cholesterol at 6 months
Title
total cholesterol change
Description
total cholesterol (mmol/L)
Time Frame
Change from Baseline total cholesterol at 12 months
Title
fast blood glucose change
Description
fast blood glucose (mmol/L)
Time Frame
Change from Baseline fast blood glucose at 6 months
Title
fast blood glucose change
Description
fast blood glucose (mmol/L)
Time Frame
Change from Baseline fast blood glucose at 12 months
Title
waist circumstance change
Description
waist circumstance (cm)
Time Frame
Change from Baseline waist circumstance at 6 months
Title
waist circumstance change
Description
waist circumstance (cm)
Time Frame
Change from Baseline waist circumstance at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
Facility Name
First Affiliated Hospital of Jinzhou Medical University
City
Jinzhou
State/Province
Liaoning
ZIP/Postal Code
121000
Country
China

12. IPD Sharing Statement

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Calorie Restricted Diet and Exercise

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