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Register:	ClinicalTrials.gov
Last refreshed on:	5 July 2021
Main ID:	NCT04949958
Date of registration:	26/06/2021
Prospective Registration:	Yes
Primary sponsor:	Riphah International University
Public title:	Effects of Exercise Based Manual in Sedentary Prediabetic Population
Scientific title:	Effects of Exercise Based Manual on Biochemical, Cardiorespiratory and Physical Parameters in Sedentary Prediabetic Population
Date of first enrolment:	September 15, 2021
Target sample size:	100
Recruitment status:	Not yet recruiting
URL:	https://clinicaltrials.gov/show/NCT04949958
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Pakistan

Contacts

Name:	Sana Hafeez, PhD*
Address:
Telephone:	92331-4545667
Email:	sana.hafeez@riphah.edu.pk
Affiliation:

Name:	Sana Hafeez, PhD*
Address:
Telephone:	92331-4545667
Email:	sana.hafeez@riphah.edu.pk
Affiliation:

Name:	Syed Shakil ur Rehman, PhD
Address:
Telephone:
Email:
Affiliation:	Riphah International University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Serum glucose test indicating prediabetic (HbA1c level of 5.7% - 6.4% or fasting
plasma glucose of 100 - 12

- Sedentary Subjects (<150 min/week or <600 MET-min/week on IPAQ Urdu Version)

Exclusion Criteria:•

- History of type 2 diabetes mellitus or newly diagnosed diabetes within last 6 months

- BMI under 18.5 and more 30

- Persons involve in other weight management program,

- History of taking any herbal medications to control the weight

- Clinical history of cardiovascular diseases occurred within the past six months

- Pregnancy

Age minimum: 18 Years
Age maximum: 44 Years
Gender: All

Health Condition(s) or Problem(s) studied

PreDiabetes

Intervention(s)

Other: Control

Other: Exercise Based Manual (Home Based)

Other: Exercise Based Manual (Supervised)

Primary Outcome(s)

Baseline Dyspnea Index(BDI) [Time Frame: 16 weeks]

Body fat percentage [Time Frame: 16 weeks]

Body mass index (BMI) [Time Frame: 16 weeks]

Fasting blood Glucose(FBG) [Time Frame: 16 weeks]

Hemoglobin A1c Test (HbA1C0 [Time Frame: 16 week]

high-density lipoproteins( HDL) [Time Frame: 16 weeks]

Homeostasis model assessment of ß-cell function(HOMA-ß) [Time Frame: 16 weeks]

Homeostatic Model Assessment for Insulin Resistance(HOMA-IR) [Time Frame: 16 weeks]

low-density lipoproteins(LDL) [Time Frame: 16 weeks]

Maximal oxygen consumption( VO2max) [Time Frame: 16 weeks]

Rate of perceived exertion( PRE) [Time Frame: 16 weeks]

Triglycerides [Time Frame: 16 weeks]

waist circumference [Time Frame: 16 weeks]

waist to hip ratio (WHR) [Time Frame: 16 weeks]

weight in kilograms [Time Frame: 16 weeks]

Secondary Outcome(s)

Secondary ID(s)

REC/Lhr/21/1103 Sana Hafeez

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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