- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07713030
Comparative Effects of High-Intensity Interval Training and Continuous Endurance Training Among Prediabetic Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Iqbal Tariq, pHD
- Phone Number: 333826752
- Email: iqbal.tariq@riphah.edu.pk
Study Contact Backup
- Name: Misdaq Batool, MS PT
- Phone Number: 03466584498
- Email: misdaaqbatool@yahoo.com.ph
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 40100
- Recruiting
- Rihpah international university Lahore campus
-
Contact:
- Misdaq Batool, MS PT
- Phone Number: 03466584498
- Email: misdaaqbatool@yahoo.com.ph
-
Contact:
- Areeza Mansha, MS PT
- Phone Number: 03363405060
- Email: Areeza154@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High-Intensity Interval Training
High intensity interval training is a training method that involves repeated bouts of short duration, highintensity exercise typicallyb performed at ≥ 85 -95% of maximal heart rate or vo2 max interspersed with period of low intensity recovery or complete rest.
|
5 minutes warm up including walk
|
|
Active Comparator: Continuous Endurance Training
Continuous endurance training also called moderate intensity continuous training involves sustained exercise at a moderate and steady intensity typically 60to 75% of vo2 max or maximal heart rate performed for a continuous duration without rest intervals
|
5 to 10 minute walking (warm up )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fasting blood glucose
Time Frame: 12 weeks
|
Participants were instructed to fast overnight for 8 to 12 hours.
FBG was measured using an automated glucose analyzer
|
12 weeks
|
|
Forced Vital Capacity
Time Frame: 12 weeks
|
Spirometry using devices like a digital spirometry will be used.
Forced Vital Capacity (FVC) will be measured in liters (L) using spirometry.
FVC represents the maximum volume of air that can be forcefully exhaled after a maximal inspiration.
|
12 weeks
|
|
Forced Expiratory Volume in One Second
Time Frame: 12 weeks
|
Forced Expiratory Volume in One Second (FEV₁) will be measured in liters (L) using spirometry.
FEV₁ represents the volume of air exhaled during the first second of a forced expiratory maneuver.
|
12 weeks
|
|
FEV₁/FVC ratio
Time Frame: 12 weeks
|
The FEV₁/FVC ratio will be expressed as a percentage (%) and calculated from spirometric measurements to assess the degree of airflow limitation.
|
12 weeks
|
|
HbA1c
Time Frame: 12 weeks
|
HbA1c was assesed through high performance liquid chromatography
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body mass index (BMI)
Time Frame: 12 weeks
|
Participants weight was measured using a calibrated digital scale with minimal clothing and no shoes height was measured using a wall mounted stadiometer with participants standing upright
|
12 weeks
|
|
IPAQ (short form) questionnaire
Time Frame: 12 weeks
|
International physical activity questionnaire is applicable for survey among 18 to 65 years to Assess the level of physical activity along different countries. It is developed in 2 Versions; first is long version (27 items), and the second is the short version (7 items). We will use IPAQ short version which consists of job, transport, domestic, and leisure time physical activity domains. Moderate and high-intensity walking and sitting time activities are addressed in this questionnaire |
12 weeks
|
|
Maximal Oxygen Uptake (VO₂max)
Time Frame: 12 weeks
|
In this research VO2 Max will be measured through a submaximal 6 mint walk test
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arjumand Bano, MS, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Hyperglycemia
- Behavior
- Nutritional and Metabolic Diseases
- Prediabetic State
- Glucose Intolerance
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Conditioning, Human
- Exercise
- High-Intensity Interval Training
Other Study ID Numbers
- REC/RCR & AHS/25/0302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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