Calorie Restricted Diet and Exercise

January 15, 2023 updated by: Hongyu Wang, The First People's Hospital of Jingzhou

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Jinzhou, Liaoning, China, 121000
        • First Affiliated Hospital of Jinzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Calorie restricted diet and exercise intervention

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline KOOS at 6 months
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.
Change from Baseline IKDC at 6 months
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)
Change from Baseline KOOS at 12 months
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.
Change from Baseline IKDC at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline pain at 6 months
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.
Change from Baseline pain at 12 months
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.
Change from Baseline symptoms at 6 months
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.
Change from Baseline symptoms at 12 months
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.
Change from Baseline activity of daily living at 6 months
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.
Change from Baseline activity of daily living at 12 months
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.
Change from Baseline sport and recreational function at 6 months
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.
Change from Baseline sport and recreational function at 12 months
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.
Change from Baseline knee related quality of life at 6 months
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.
Change from Baseline knee related quality of life at 12 months
systolic blood pressure change
Time Frame: Change from Baseline systolic blood pressure at 6 months
systolic blood pressure /mmHg
Change from Baseline systolic blood pressure at 6 months
systolic blood pressure change
Time Frame: Change from Baseline systolic blood pressure at 12 months
systolic blood pressure /mmHg
Change from Baseline systolic blood pressure at 12 months
diastolic blood pressure change
Time Frame: Change from Baseline diastolic blood pressure at 6 months
diastolic blood pressure/mmHg
Change from Baseline diastolic blood pressure at 6 months
diastolic blood pressure change
Time Frame: Change from Baseline diastolic blood pressure at 12 months
diastolic blood pressure/mmHg
Change from Baseline diastolic blood pressure at 12 months
body mass index change
Time Frame: Change from Baseline body mass index at 6 months
body mass index /kg/㎡
Change from Baseline body mass index at 6 months
body mass index change
Time Frame: Change from Baseline body mass index at 12 months
body mass index /kg/㎡
Change from Baseline body mass index at 12 months
weight change
Time Frame: Change from Baseline weight at 6 months
Weight-kg
Change from Baseline weight at 6 months
weight change
Time Frame: Change from Baseline weight at 12 months
Weight-kg
Change from Baseline weight at 12 months
high-density lipoprotein cholesterol change
Time Frame: Change from Baseline high-density lipoprotein cholesterol at 6 months
high-density lipoprotein cholesterol (mmol/L)
Change from Baseline high-density lipoprotein cholesterol at 6 months
high-density lipoprotein cholesterol change
Time Frame: Change from Baseline high-density lipoprotein cholesterol at 12 months
high-density lipoprotein cholesterol (mmol/L)
Change from Baseline high-density lipoprotein cholesterol at 12 months
low-density lipoprotein cholesterol change
Time Frame: Change from Baseline low-density lipoprotein cholesterol at 6 months
low-density lipoprotein cholesterol (mmol/L)
Change from Baseline low-density lipoprotein cholesterol at 6 months
low-density lipoprotein cholesterol change
Time Frame: Change from Baseline low-density lipoprotein cholesterol at 12 months
low-density lipoprotein cholesterol (mmol/L)
Change from Baseline low-density lipoprotein cholesterol at 12 months
triglycerides change
Time Frame: Change from Baseline triglycerides at 6 months
triglycerides (mmol/l)
Change from Baseline triglycerides at 6 months
triglycerides change
Time Frame: Change from Baseline triglycerides at 12 months
triglycerides (mmol/l)
Change from Baseline triglycerides at 12 months
total cholesterol change
Time Frame: Change from Baseline total cholesterol at 6 months
total cholesterol (mmol/L)
Change from Baseline total cholesterol at 6 months
total cholesterol change
Time Frame: Change from Baseline total cholesterol at 12 months
total cholesterol (mmol/L)
Change from Baseline total cholesterol at 12 months
fast blood glucose change
Time Frame: Change from Baseline fast blood glucose at 6 months
fast blood glucose (mmol/L)
Change from Baseline fast blood glucose at 6 months
fast blood glucose change
Time Frame: Change from Baseline fast blood glucose at 12 months
fast blood glucose (mmol/L)
Change from Baseline fast blood glucose at 12 months
waist circumstance change
Time Frame: Change from Baseline waist circumstance at 6 months
waist circumstance (cm)
Change from Baseline waist circumstance at 6 months
waist circumstance change
Time Frame: Change from Baseline waist circumstance at 12 months
waist circumstance (cm)
Change from Baseline waist circumstance at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First People's Hospital of Jingzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • exercise01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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