Effect of Exercise on Cardiometabolic Risk Factors in Type II Diabetic Patients

NCT ID: NCT04759469

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-12-01

Brief Summary

Background: Physical activity is known to modify some of the diabetes risk factors; however, solid evidence is still needed to precisely know the optimum form of training best fits the individual needs of type II diabetic (T2D) patients.

Detailed Description

Objectives: the purpose of this study was to compare between high intensity interval training (HIIT) and moderate-intensity interval training (MIIT) effect on functional capacity (as a cardiorespiratory parameter), and on glucose control and glycated hemoglobin (HbA1C) (as metabolic parameters) in T2D patients, and to test exercise acceptability within these patients. Methods: 60 participants had participated in this study. Their ages ranged from 45 to 65 years. They were randomized into two equal groups (30/group); group (A) did HIIT and group (B) did MIIT. Both groups received 12 weeks of training. Measurements for six minute walking distance (6MWD), fasting blood glucose (FBG), and HbA1C levels were done before and after the study. Physical activity enjoyment scale (PACES) were filled by the patients by the end of the study; testing exercise enjoyment.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High-intensity interval training (HIIT)

A high-intensity interval training program for 3 days/week (day after day) for 12 weeks on atreadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program intensity.

Group Type: EXPERIMENTAL

High-intensity interval training

Intervention Type: BEHAVIORAL

High-intensity interval training is a form of intermittent training using relatively high exercise intensity

Moderate intensity interval training (MIIT)

A moderate intensity interval training program for 3 days/week (alternate days) on a treadmill (Biodex RTM500, Biodex Inc., New York), with a gradual increase in the program.

Group Type: ACTIVE_COMPARATOR

Moderate intensity interval training

Intervention Type: BEHAVIORAL

Moderate intensity interval training is a form of intermittent training using moderate exercise intensity

Interventions

High-intensity interval training

High-intensity interval training is a form of intermittent training using relatively high exercise intensity

Intervention Type: BEHAVIORAL

Moderate intensity interval training

Moderate intensity interval training is a form of intermittent training using moderate exercise intensity

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Controlled type 2 diabetic patients who were clinically stable for at least 3 months before entering the study,
• Aged 45-65 years
• Non-smokers
• body mass index (BMI) ranged between 20 to 39.9 Kg/m2
• Fasting blood glucose ranged from (126-160) mg/dl
• Sedentary lifestyle who didn't engage in physical activity for more than half an hour/ day for at least one month before entering the study.

Exclusion Criteria

• unstable medical condition
• smoker, recent surgery
• Body mass index is more than 39.9 kg/m2 or less than 20 kg/m2
• Any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hady Atef Labib

Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hady Atef, PhD

Role: STUDY_DIRECTOR

Lecturer of physical therapy, Cairo University, Egypt

Locations

Alkasr Alaini hospital

Cairo, AI Qahirah, Egypt

Countries

Egypt

Other Identifiers

HIIT on DM

Identifier Type: -

Identifier Source: org_study_id