Clinical trial NCT04759469: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type II diabetes
cardiometabolic risk
high-intensity interval training
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2021-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: six minute walking distance (in meters)
timeFrame: 12 weeks
measure: Glycated Hemoglobin (HbA1C)
timeFrame: 12 weeks
measure: Fasting blood glucose
timeFrame: 12 weeks
measure: Exercise enjoyment and acceptability
timeFrame: 12 weeks
Secondary outcomes:
measure: Adherence rates
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alkasr Alaini hospital
state: AI Qahirah
Study officials:
affiliation: Lecturer of physical therapy, Cairo University, Egypt
name: Hady Atef, PhD
role: STUDY_DIRECTOR
References: