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

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

aerobic exercises

resistance exercises

About this trial

This is an interventional other trial for Diabete Type 2

Eligibility Criteria

40 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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: Patients with uncontrolled blood glucose level 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. Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease). Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis). Patients with BMI > 35 will be excluded from the study.

Sites / Locations

Egyptian Chineese University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

aerobic exercises group (group A )

resistance exercises group (group B)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

homocystiene

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

Secondary Outcome Measures

insulin

normal value <25 mlu/L fasting

cholestrol

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

Full Information

NCT ID

NCT05845190

First Posted

April 26, 2023

Last Updated

April 26, 2023

Sponsor

Egyptian Chinese University

1. Study Identification

Unique Protocol Identification Number

NCT05845190

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 4, 2022 (Actual)

Primary Completion Date

May 15, 2023 (Anticipated)

Study Completion Date

May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Egyptian Chinese University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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

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.

6. Conditions and Keywords

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

Diabete Type 2

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

simple randomization using a randomization table created by a computer software program

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aerobic exercises group (group A )

Arm Type

Experimental

Arm Description

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

Arm Title

resistance exercises group (group B)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

aerobic exercises

Other Intervention Name(s)

group A

Intervention Description

aerobic exercises in form of walking on treadmill

Intervention Type

Other

Intervention Name(s)

resistance exercises

Other Intervention Name(s)

group B

Intervention Description

60% of One-repetition maximum 3 sets ( 8 to 12 ) repetitions

Primary Outcome Measure Information:

Title

homocystiene

Description

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

Time Frame

12 weeks of training

Secondary Outcome Measure Information:

Title

insulin

Description

normal value <25 mlu/L fasting

Time Frame

12 weeks of training

Title

cholestrol

Description

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

Time Frame

12 weeks of trianing

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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: Patients with uncontrolled blood glucose level 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. Patients with severe pulmonary disease (with restrictive lung disease or with obstructive lung disease). Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis or severe osteoarthritis). Patients with BMI > 35 will be excluded from the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

hanan hassan

Organizational Affiliation

Egyptian Chinese University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Egyptian Chineese University

City

Cairo

State/Province

Gesr Elsuez

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

all of the individual participant data collected during the trail, after de-identification

IPD Sharing Time Frame

immediately following publication , no end data

IPD Sharing Access Criteria

anyone who whishes to access the data, for any purpose

Diabete Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial