Comparative Effects of High-Intensity Interval Training and Continuous Endurance Training Among Prediabetic Patients

Официальное название

Comparative Effects of High-Intensity Interval Training and Continuous Endurance Training on Glycemic Control, BMI, Vo₂ Max, Pulmonary Function, and Physical Activity Among Prediabetic Patients

Обзор

Prediabetics is a condition where blood sugar levels are normal but not yet high enough to be diagnosed as type 2 diabetes. This phase offers a crucial point for timely intervention to delay or prevent type 2 diabetes. The objective of the study will be to find the effects of high intensity interval and continuous endurance training on glycemic control, BMI, Vo2 Max, pulmonary function and physical activity among prediabetic patients. Study design will be randomized control trial. Total 80 participants will be enrolled in study. The data will be collected from faculty of Riphah International University, Lahore. The study will be completed within 8 months after approval of synopsis. A simple random sampling will be used to assign the groups; group A and group B. Group A will be assigned high intensity interval training and group B will be assigned to continuous training.

Подробное описание

Prediabetics is a condition where blood sugar levels are normal but not yet high enough to be diagnosed as type 2 diabetes. This phase offers a crucial point for timely intervention to delay or prevent type 2 diabetes. The objective of the study will be to find the effects of high intensity interval and continuous endurance training on glycemic control, BMI, Vo2 Max, pulmonary function and physical activity among prediabetic patients. Study design will be randomized control trial. Total 80 participants will be enrolled in study. The data will be collected from faculty of Riphah International University, Lahore. The study will be completed within 8 months after approval of synopsis. A simple random sampling will be used to assign the groups: group A and group B. Group A will be assigned high intensity interval training, and group B will be assigned to continuous training. Both interventions will be conducted over a 12-week period, with pre- and post-intervention assessments. Each exercise session constitutes a 5-minute warm up and finished with a 5-minute cool-down. Participants aged between 35 to 54 years with sedentary lifestyle, Stable medical condition, and stable body weight with changes less 3kg in the past 6 months will be included in this study. The study will exclude individuals with uncontrolled hypertension, history of heart disease, myocardial infarction and stroke and diagnosed type 2 diabetes, use of specific medications, severe obesity, high fasting blood glucose, previous history of respiratory problems, and smoking. Primary outcomes include changes in fasting blood glucose, HbA1c levels, and insulin sensitivity. Pre and post values of glucose level and FEV1, FVC and FEV1/FVC will be calculated. Secondary outcomes will assess BMI, VO₂ max through graded exercise testing, pulmonary function using spirometry, and physical activity levels measured by validated questionnaire of short form of IPAQ-SF. Data will be analysed using SPSS 24 and Shapiro wilks test will be applied to assess the normality of data. After assesing the normality of data paired sample/independent t test/ANOVA test will be applied to find which technique will be more beneficial for prediabetic patients.

Вмешательства

• Поведенческое High-Intensity Interval Training
  5 minutes warm up including walk * 30s fast stairs climbing * 60s slow walk down * Repeat 5 to 6 rounds * 5 minute stretching or slow walk (cool down)
• Поведенческое Continuous Endurance Training
  5 to 10 minute walking (warm up ) * 25 to 30minutes at 60 to 70 %continuous training * Continuous walk for 15 to 20 minutes. * 5 to 10 minutes stretching (cool down)

Первичные конечные точки

• fasting blood glucose [Срок оценки: 12 weeks]
• Forced Vital Capacity [Срок оценки: 12 weeks]
• Forced Expiratory Volume in One Second [Срок оценки: 12 weeks]
• FEV₁/FVC ratio [Срок оценки: 12 weeks]
• HbA1c [Срок оценки: 12 weeks]

Вторичные конечные точки (3)

• Body mass index (BMI) [Срок оценки: 12 weeks]
• IPAQ (short form) questionnaire [Срок оценки: 12 weeks]
• Maximal Oxygen Uptake (VO₂max) [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Sedentary lifestyle (Individuals reporting minimal structured physical activity e.g., <30 minutes of exercise per week) .

• Stable Medical Condition (No history of significant cardiovascular events, uncontrolled hypertension, or other major comorbidities).
• Stable Body Weight (Stable body weight with changes less than 3 kg in the past 6 months).

Критерии исключения

• uncontrolled hypertension

• history of heart disease
• myocardial infarction
• stroke
• Use of Specific Medications (Current use of insulin or other medications affecting glucose metabolism or exercise response)
• Severe Obesity (Individuals with a BMI ≥ 40 kg/m)
• High fasting blood glucose (Fasting blood glucose of >100mg.dl-1)
• Previous history of respiratory problems
• Smoking

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Rihpah international university Lahore campus — Lahore

Идентификаторы

NCT: NCT07713030 · REC/RCR & AHS/25/0302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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