NCT05845190

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

April 26, 2023

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • homocystiene

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

    12 weeks of training

Secondary Outcomes (2)

  • insulin

    12 weeks of training

  • cholestrol

    12 weeks of trianing

Study Arms (2)

aerobic exercises group (group A )

EXPERIMENTAL

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

resistance exercises group (group B)

EXPERIMENTAL

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

Interventions

aerobic exercises in form of walking on treadmill

Also known as: group A
aerobic exercises group (group A )

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

Also known as: group B
resistance exercises group (group B)

Eligibility Criteria

Age40 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • All patients are medically and psychologically stable

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egyptian Chineese University

Cairo, Gesr Elsuez, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • hanan hassan

    Egyptian Chinese University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: simple randomization using a randomization table created by a computer software program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

April 4, 2022

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

May 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

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

Time Frame
immediately following publication , no end data
Access Criteria
anyone who whishes to access the data, for any purpose

Locations