Recruiting NCT07713030

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

No phase Interventional PreDiabetes Pre Diabetes Prediabetic State

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: High-Intensity Interval Training, Continuous Endurance Training.
Who it may be relevant to: Registry conditions: PreDiabetes, Pre Diabetes, Prediabetic State. Basic parameters: 35 years — 54 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Pakistan
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Official title

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

Overview

Detailed description

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.

Interventions

Behavioral 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)
Behavioral 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)

Primary outcome measures

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

Secondary outcome measures (3)

Body mass index (BMI) [Time frame: 12 weeks]
IPAQ (short form) questionnaire [Time frame: 12 weeks]
Maximal Oxygen Uptake (VO₂max) [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

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).

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

Pakistan · 1 center

Rihpah international university Lahore campus — Lahore

Identifiers

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

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗