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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High-intensity interval training
Moderate intensity interval training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type II diabetes, cardiometabolic risk, high-intensity interval training

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alkasr Alaini hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity interval training (HIIT)

Moderate intensity interval training (MIIT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

six minute walking distance (in meters)
represent aerobic capacity (distance walked in 6 min)
Glycated Hemoglobin (HbA1C)
Representing glucose control over 120 days
Fasting blood glucose
Representing glucose level after 9 hours fasting
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.

Secondary Outcome Measures

Adherence rates
To what extent the patients will adhere to the exercise protocol

Full Information

First Posted
February 15, 2021
Last Updated
March 18, 2021
Sponsor
Cairo University
Collaborators
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04759469
Brief Title
Effect of Exercise on Cardiometabolic Risk Factors in Type II Diabetic Patients
Official Title
Effect of Time-efficient Exercise Training on Cardiometabolic Risk Factors in Type II Diabetic Patients: A Randomized Mixed-methods Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type II diabetes, cardiometabolic risk, high-intensity interval training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training (HIIT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate intensity interval training (MIIT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval training
Intervention Description
High-intensity interval training is a form of intermittent training using relatively high exercise intensity
Intervention Type
Behavioral
Intervention Name(s)
Moderate intensity interval training
Intervention Description
Moderate intensity interval training is a form of intermittent training using moderate exercise intensity
Primary Outcome Measure Information:
Title
six minute walking distance (in meters)
Description
represent aerobic capacity (distance walked in 6 min)
Time Frame
12 weeks
Title
Glycated Hemoglobin (HbA1C)
Description
Representing glucose control over 120 days
Time Frame
12 weeks
Title
Fasting blood glucose
Description
Representing glucose level after 9 hours fasting
Time Frame
12 weeks
Title
Exercise enjoyment and acceptability
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adherence rates
Description
To what extent the patients will adhere to the exercise protocol
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hady Atef, PhD
Organizational Affiliation
Lecturer of physical therapy, Cairo University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Alkasr Alaini hospital
City
Cairo
State/Province
AI Qahirah
ZIP/Postal Code
11847
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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