Calorie Restricted Diet and Exercise

Sponsor
The First People's Hospital of Jingzhou (Other)
Overall Status
Completed
CT.gov ID
NCT05092178
Collaborator
(none)
100
1
2
33.5
3

Study Details

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 tears(DMTs) was still poorly investigated.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: calorie restricted diet and exercise
N/A

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 [23]. The energy intake per day of the calorie restricted diet was calculated based on the detailed composition of meals such as rice, vegetables, eggs, pork, and beef, using the Chinese food composition tables[24]. 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 were guided by a dietitian for modulations of their caloric intake weekly for six months.

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. Calorie restricted diet and exercise group contain both the above intervention for 6 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Calorie-restricted Diet and Exercise Intervention vs Exercise Control on the Knee Function Outcomes of Metabolic Syndrome Patients With Degenerate Meniscus Tears at 1 Year Follow up
Actual Study Start Date :
Dec 6, 2018
Actual Primary Completion Date :
Jun 4, 2021
Actual Study Completion Date :
Sep 20, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Calorie restricted diet and excecise 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 [23]. Participants were guided by a dietitian for modulations of their caloric intake weekly for six months. The exercise intervention consists of aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for≥2 d•wk for six months. Calorie restricted diet and exercise group contain both the above intervention 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

participants then underwent libitum diet and the same exercise intervention during the program

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.

Outcome Measures

Primary Outcome Measures

  1. KOOS [up to 12 months]

    the questionnaires of the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales

  2. IKDC [up to 12 months]

    the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) score

Secondary Outcome Measures

  1. subscales of the KOOS pain [up to 12 month]

    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

  2. KOOS symptoms [up to 12 month]

    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

  3. KOOS activity of daily living [up to 12 month]

    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

  4. sport and recreational function [up to 12 month]

    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

  5. knee related quality of life [up to 12 month]

    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

  6. SBP [up to 12 month]

    systolic blood pressure

  7. DBP [up to 12 month]

    diastolic blood pressure

  8. BMI [up to 12 month]

    body mass index

  9. weight [up to 12 month]

    weight

  10. HDL [up to 12 month]

    high-density lipoprotein cholesterol

  11. LDL-C [up to 12 month]

    low-density lipoprotein cholesterol

  12. TG [up to 12 month]

    triglycerides

  13. TC [up to 12 month]

    total cholesterol

  14. FBG [up to 12 month]

    fast blood glucose

  15. WC [up to 12 month]

    waist circumstance

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital of Jinzhou Medical University Jinzhou Liaoning China 121000

Sponsors and Collaborators

  • The First People's Hospital of Jingzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hongyu Wang, the chief residents, Shenzhen People's Hospital
ClinicalTrials.gov Identifier:
NCT05092178
Other Study ID Numbers:
  • exercise01
First Posted:
Oct 25, 2021
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021