Protocol summary

Study aim
The primary aim of this study is to compare the effects of lipid-lowering drugs and a 10-week resistance band training program on lipid profiles, body composition, and overall health outcomes in obese patients with elevated cholesterol levels.
Design
Pragmatic, community based, parallel group, double blinded, randomized controlled trial. Total 380 patients will be enrolled.
Settings and conduct
Muhammad physical therapy clinic and rehabilitation center, Multan.
Participants/Inclusion and exclusion criteria
Inclusion criteria • Adults aged 18-65 years • Diagnosed with dyslipidemia, defined as elevated levels of total cholesterol, LDL cholesterol or triglycerides , or low HDL cholesterol • Able and willing to adhere to either drug therapy or a structured exercise program Exclusion Criteria • History of cardiovascular diseases • Uncontrolled hypertension • Recent history of smoking or current tobacco use • Conditions contraindicating exercise • Current use of lipid-lowering drugs or recent participation in a structured exercise program • Pregnant or lactating women
Intervention groups
Group A: Will receive e.g., Rosuvastatin 5mg administered orally once daily. Group B: Participants in the exercise intervention group will undergo a structured resistance training program, tailored to individual fitness levels and conducted under the supervision of a certified exercise trainer. The exercise regimen will include a 5-minute warm-up, 30 minutes of resistance training (including chest press, seated row, shoulder press, biceps curl, squats, deadlift, wood chopper, Russian twists), followed by a 5-minute cool-down. Training sessions will be held three times a week for 12 weeks
Main outcome variables
Lipid profile parameters (total cholesterol, low density lipids, high density lipids, and triglycerides) will be measured at three time points: baseline, 5 weeks, and 10 weeks.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230202057310N15
Registration date: 2024-12-27, 1403/10/07
Registration timing: prospective

Last update: 2024-12-27, 1403/10/07
Update count: 0
Registration date
2024-12-27, 1403/10/07
Registrant information
Name
Imran Ahmad Khan
Name of organization / entity
Muhammad Nawaz Shareef University of Agriculture, Multan
Country
Pakistan
Phone
+92 333 6120602
Email address
imran.ahmad@mnsuam.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-06, 1403/10/17
Expected recruitment end date
2025-04-06, 1404/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of rosuvastatin and 10-week resistance band exercises for obese individuals of Multan
Public title
Rosuvastatin and 10-week resistance band exercises for obese individuals of Multan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged 18-65 years • Diagnosed with dyslipidemia, defined as elevated levels of total cholesterol (≥200 mg/dL) Able and willing to adhere to either drug therapy or a structured exercise program LDL cholesterol (≥130 mg/dL) Triglycerides (≥150 mg/dL) ow HDL cholesterol (<40 mg/dL for men, <50 mg/dL for women)
Exclusion criteria:
History of cardiovascular diseases (e.g., myocardial infarction, angina) Uncontrolled hypertension (≥160/100 mmHg) Conditions contraindicating exercise (e.g., musculoskeletal disorders) Recent history of smoking or current tobacco use Current use of lipid-lowering drugs or recent participation in a structured exercise program Pregnant or lactating women
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 380
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2024-12-07, 1403/09/17
Ethics committee reference number
MIMAS/07/19/IAK

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Lipid profile parameters (total cholesterol, LDL, HDL, and triglycerides)
Timepoint
10 weeks
Method of measurement
Blood sample

2

Description
Body mass index
Timepoint
10 weeks
Method of measurement
Calculated from weight and height (measured using a digital scale and stadiometer).

Secondary outcomes

1

Description
Blood pressure
Timepoint
10 weeks
Method of measurement
Measured using a calibrated sphygmomanometer after a 5-minute rest in a seated position.

2

Description
Waist-to-Hip Ratio, Hip to knee ration and Hip circumference
Timepoint
10 weeks
Method of measurement
Assessed using a flexible measuring tape

3

Description
Quality of life
Timepoint
10 weeks
Method of measurement
SF-36

Intervention groups

1

Description
Intervention group: Group 1: Participants in the drug intervention group will receive e.g., Rosuvastatin 5mg administered orally once daily. This medication has been selected based on its established efficacy in lowering LDL cholesterol and improving overall lipid profiles
Category
Treatment - Drugs

2

Description
Intervention group: Participants in the exercise intervention group will undergo a structured resistance training program, tailored to individual fitness levels and conducted under the supervision of a certified exercise trainer.Exercise Protocol: The exercise regimen will include a 5-minute warm-up, 30 minutes of resistance training (including chest press, seated row, shoulder press, biceps curl, squats, deadlift, wood chopper, Russian twists), followed by a 5-minute cool-down. Training sessions will be held three times a week for 10 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Muhammad Rehabilitation Centre, Multan
Full name of responsible person
Komal Ammar Bukhari
Street address
Multan
City
MULTAN
Postal code
66000
Phone
+92 333 6120602
Email
komalbukhari680@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Qurat Ul Ain
Street address
Multan
City
Multan
Postal code
66000
Phone
+92 333 6120602
Email
qain0635@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/12/4Kiran
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Proportion provided by this source
70
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Maliha Khalid Khan
Position
Punjab
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
malihatareen1997@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Muhammad Nawaz Sharif University of Agriculture Multan
Full name of responsible person
Imran Ahmad Khan
Position
Punjab
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Old shuja Abad road Multan
City
MULTAN
Province
Punjab
Postal code
66000
Phone
+92 333 6120602
Email
imran.ahmad@mnsuam.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Full name of responsible person
Kiran Ashraf
Position
Final Year Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6827130
Email
Kiranashraf523@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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