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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04759469
• Other study ID #: HIIT on DM
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• High-intensity interval training
High-intensity interval training is a form of intermittent training using relatively high exercise intensity
• Moderate intensity interval training
Moderate intensity interval training is a form of intermittent training using moderate exercise intensity

Locations

Country	Name	City	State
Egypt	Alkasr Alaini hospital	Cairo	AI Qahirah

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six minute walking distance (in meters)	represent aerobic capacity (distance walked in 6 min)	12 weeks
Primary	Glycated Hemoglobin (HbA1C)	Representing glucose control over 120 days	12 weeks
Primary	Fasting blood glucose	Representing glucose level after 9 hours fasting	12 weeks
Primary	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	Adherence rates	To what extent the patients will adhere to the exercise protocol	12 weeks