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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04759469
Enrollment
60
Registered
2021-02-18
Start date
2018-12-01
Completion date
2019-12-01
Last updated
2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type II diabetes, cardiometabolic risk, high-intensity interval training

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.

Interventions

BEHAVIORALHigh-intensity interval training

High-intensity interval training is a form of intermittent training using relatively high exercise intensity

Moderate intensity interval training is a form of intermittent training using moderate exercise intensity

Sponsors

Kasr El Aini Hospital
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
six minute walking distance (in meters)12 weeksrepresent aerobic capacity (distance walked in 6 min)
Glycated Hemoglobin (HbA1C)12 weeksRepresenting glucose control over 120 days
Fasting blood glucose12 weeksRepresenting glucose level after 9 hours fasting
Exercise enjoyment and acceptability12 weeksThe 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

MeasureTime frameDescription
Adherence rates12 weeksTo what extent the patients will adhere to the exercise protocol

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026