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

NCT04759469 | Completed

• 1 other identifier: HIIT on DM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type II diabetes; cardiometabolic risk; high-intensity interval training

Outcome Measures

Primary Outcomes (4)

• six minute walking distance (in meters)

  represent aerobic capacity (distance walked in 6 min)

  12 weeks

• Glycated Hemoglobin (HbA1C)

  Representing glucose control over 120 days

  12 weeks

• Fasting blood glucose

  Representing glucose level after 9 hours fasting

  12 weeks

• Exercise enjoyment and acceptability

  The Physical Activity Enjoyment Scale (PACES) score, out of 119. It is an 18-item scale that assesses enjoyment for physical activity by asking participants to rate "how you feel at the moment about the physical activity you have been doing" using a 7-point bipolar Likert scale, from 1 (I enjoy it) to 7 (I hate it). Eleven items were negatively worded and seven items were positively worded. After reverse scoring the 11negatively worded items, an overall enjoyment for physical activity score is determined by summing the items, with a range of 18-126 being possible. Higher scores indicate higher enjoyment.

  12 weeks

Secondary Outcomes (1)

• Adherence rates

  12 weeks

Study Arms (2)

High-intensity interval training (HIIT)

EXPERIMENTAL

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.

Behavioral: High-intensity interval training

Moderate intensity interval training (MIIT)

ACTIVE COMPARATOR

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.

Behavioral: Moderate intensity interval training

Interventions

High-intensity interval training BEHAVIORAL

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

High-intensity interval training (HIIT)

Moderate intensity interval training BEHAVIORAL

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

Moderate intensity interval training (MIIT)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Kasr El Aini Hospital: collaborator

Study Sites (1)

Alkasr Alaini hospital

Cairo, AI Qahirah, 11847, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hady Atef, PhD

  Lecturer of physical therapy, Cairo University, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for cardiopulmonary disorders, Faculty of Physical therapy

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: December 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after 1 month for12 months
• Access Criteria: will upload it to the journal of publication

Locations

EG (1)