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Completed

NCT Number: NCT04759469

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alkasr Alaini hospital

Cairo, AI Qahirah, 11847, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity interval training

Behavioral

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

Moderate Intensity Interval Training

Behavioral

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

Primary outcomes

  1. six minute walking distance (in meters)

    Time frame: 12 weeks

    represent aerobic capacity (distance walked in 6 min)

  2. Glycated Hemoglobin (HbA1C)

    Time frame: 12 weeks

    Representing glucose control over 120 days

  3. Fasting blood glucose

    Time frame: 12 weeks

    Representing glucose level after 9 hours fasting

  4. Exercise enjoyment and acceptability

    Time frame: 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 outcomes

  1. Adherence rates

    Time frame: 12 weeks

    To what extent the patients will adhere to the exercise protocol

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kasr El Aini Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Feb 18, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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