Effect of Exercise on Cardiometabolic Risk Factors in Type II Diabetic Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Behavioral: High-intensity interval trainingBehavioral: Moderate intensity interval training
- Registration Number
- NCT04759469
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-intensity interval training (HIIT) High-intensity interval training 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. Moderate intensity interval training (MIIT) Moderate intensity interval training 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.
- Primary Outcome Measures
Name Time Method six minute walking distance (in meters) 12 weeks represent aerobic capacity (distance walked in 6 min)
Glycated Hemoglobin (HbA1C) 12 weeks Representing glucose control over 120 days
Fasting blood glucose 12 weeks Representing glucose level after 9 hours fasting
Exercise enjoyment and acceptability 12 weeks 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
Name Time Method Adherence rates 12 weeks To what extent the patients will adhere to the exercise protocol
Trial Locations
- Locations (1)
Alkasr Alaini hospital
🇪🇬Cairo, AI Qahirah, Egypt