Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients

Sponsor
Egyptian Chinese University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05845190
Collaborator
(none)
60
1
2
13.3
4.5

Study Details

Study Description

Brief Summary

The goal of this [clinical trial] is to [ compare ] in [ diabetic male patients ]. The main question to answer is :

Will be any difference between aerobic exercises and resistance exercises in improving levels of homocysteine, cholesterol and insulin in diabetic patients?

Participants will take their medications and group of them do aerobic exercises and another group do resistance training

Condition or Disease Intervention/Treatment Phase
  • Other: aerobic exercises
  • Other: resistance exercises
N/A

Detailed Description

40 male diabetic patients diagnosed by type 2 diabetes mellites to evaluate therapeutics outcomes of aerobic exercises versus resistance exercises as a treatment tool on homocysteine, insulin and cholesterol levels in diabetic patients.

The patients will be randomly assigned to two equal (in number) groups:

Group (A) Twenty male patients will receive moderate intensity aerobic exercises in a form of supervised treadmill walking for 30-45 mins performed 3 times/ week for 12 weeks.

Group (B) Twenty male patients will receive resistance training program comprised 30-45 min performed 3 times /week for 12 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
simple randomization using a randomization table created by a computer software programsimple randomization using a randomization table created by a computer software program
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Aerobic Training Versus Resistance Training on Plasma Homocystiene in Diabetic Patients
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: aerobic exercises group (group A )

20 male patients with diabetes mellites Attended the program of walking on treadmill for 12 weeks according to the following parameters. Exercise prescription: Intensity: started by 60-75% of target heart rate according to each patient response. Duration: Each session consisted of five minutes warming up firstly then 25-30 minutes time of session ended by five minutes cool down exercises Frequency: Three times / week (day after day) for 12 weeks

Other: aerobic exercises
aerobic exercises in form of walking on treadmill
Other Names:
  • group A
  • Experimental: resistance exercises group (group B)

    20 male patients with diabetes mellites will participate in resistance training exercises 30-45 mins. The subject will warm up and cool down for at least five to seven minutes each, (before and after exercise) with initial load of 60% of 1 repetition maximum. This program consists of 3 sets of 8 to 12 repetitions, then increasing load when subject was able to complete 12 repetitions. A rest period of 1.5 min was established between each set. Mode: 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 leg exercises (leg press, extension, and flexion), abdominal crunches and back extensions. with the individualized workloads at 60% of 1RM. Duration: 30 min-45 min (total session). Frequency: Three times / week (day after day). Intensity: increased load was established when subject was able to complete 12 repetitions.

    Other: resistance exercises
    60% of One-repetition maximum 3 sets ( 8 to 12 ) repetitions
    Other Names:
  • group B
  • Outcome Measures

    Primary Outcome Measures

    1. homocystiene [12 weeks of training]

      Homocysteine was measured with an enzyme linked immunosorbent (ELISA) method. The upper limit of normal is 15 μmol/l

    Secondary Outcome Measures

    1. insulin [12 weeks of training]

      normal value <25 mlu/L fasting

    2. cholestrol [12 weeks of trianing]

      Desirable cholesterol levels are considered to be those below 200 mg/dL in adults

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 1- Their ages will range from 40 -55 years 2- Their body mass indexes will range between (25 to 35 Kg / m²). 3-All patients are diagnosed with type 2 diabetes mellites.

    • Diagnostic criteria for type 2 diabetes were: 1) a fasting plasma glucose concentration of 7.0 mmol·L-1 or higher or 2) a plasma glucose concentration of 11.1 mmol·L-1 or higher two hours after an oral glucose challenge. (Punthakee et al.,2018).

    • All subjects took oral hypoglycemic drugs but none of them were being treated with insulin when enrolled.

    4- All patients are medically and psychologically stable

    Exclusion Criteria:
    1. Patients with uncontrolled blood glucose level

    2. Patients with unstable cardiovascular conditions (those with a known history of uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure, currently on anticoagulation therapy) were excluded from this study.

    3. Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease).

    4. Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis).

    5. Patients with BMI > 35 will be excluded from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Egyptian Chineese University Cairo Gesr Elsuez Egypt

    Sponsors and Collaborators

    • Egyptian Chinese University

    Investigators

    • Principal Investigator: hanan hassan, Egyptian Chinese University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    hanan hassan, Assistant lecturer, Egyptian Chinese University
    ClinicalTrials.gov Identifier:
    NCT05845190
    Other Study ID Numbers:
    • P.T.REC/012/003654
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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 May 6, 2023