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

Effect of Time-efficient Exercise Training on Cardiometabolic Risk Factors in Type II Diabetic Patients: A Randomized Mixed-methods Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: High-intensity interval training; Behavioral: Moderate intensity interval training

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • AI Qahirah
    • Cairo, AI Qahirah, Egypt, 11847
      • Alkasr Alaini hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: High-intensity interval training; High-intensity interval training is a form of intermittent training using relatively high exercise intensity
ACTIVE_COMPARATOR: 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.	Behavioral: Moderate intensity interval training; Moderate intensity interval training is a form of intermittent training using moderate exercise intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rates	To what extent the patients will adhere to the exercise protocol	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Kasr El Aini Hospital
• Investigators: Study Director: Hady Atef, PhD, Lecturer of physical therapy, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (ACTUAL): February 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: cardiometabolic risk; high-intensity interval training; Type II diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: HIIT on DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After approval can be shared
• IPD Sharing Time Frame: after 1 month for12 months
• IPD Sharing Access Criteria: will upload it to the journal of publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No