- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05202535
Effect of Aerobic Exercise Training in Obese Adults
September 15, 2022 updated by: Riphah International University
Effect of Aerobic Exercise Training on Arterial Stiffness and Hemodynamics in Obese Adults.
To determine the effect of aerobic exercise training on arterial stiffness and hemodynamics in obese adults.
Proper evidence on the effect of aerobic exercise training on both arterial stiffness and hemodynamics are sparsely present in obese adults whereas separate studies were done in mainly hypertensive and cardiovascular disease populations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Obese adults always have been trying to improve their quality of life by managing the complications associated with obesity like arterial stiffness and disturbed hemodynamics.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Islamabad, Punjab, Pakistan, 04404
- Polyclinic Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index ≥28 kg/m²
- Able to do exercise
Exclusion Criteria:
- Involved in structured physical activity in last 6 months
- History of chronic systemic disease (cardiovascular, pulmonary, and metabolic disease)
- Continuous medication use.
- MSK or Neurological problems
- Pregnant females
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aerobic exercise training
hospital-based aerobic exercise training on treadmill/cycle ergometer with the intensity of 40-70% of HR max, for 15-30 mints for 8 weeks
|
Hospital-based aerobic exercise training for 15-30 minutes including pre and post-vitals assessment. 3x/week on alternate days for 8 weeks at 40-70% of HR Max |
|
Active Comparator: Conventional therapy
Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks
|
Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterial Stiffness
Time Frame: 6 weeks
|
Gradual fragmentation and loss of elastin fibers and accumulation of stiffer collagen fibers in the arterial wall.
Calculated through Arterial stiffness index.
|
6 weeks
|
|
Hemodynamics
Time Frame: 6 weeks
|
Factors that govern blood flow calculated through Rate Pressure Product.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hvidt KN. Blood pressure and arterial stiffness in obese children and adolescents. Dan Med J. 2015 Mar;62(3):B5043.
- Cote AT, Phillips AA, Harris KC, Sandor GG, Panagiotopoulos C, Devlin AM. Obesity and arterial stiffness in children: systematic review and meta-analysis. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1038-44. doi: 10.1161/ATVBAHA.114.305062. Epub 2015 Jan 29.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2021
Primary Completion (Actual)
March 15, 2022
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
January 8, 2022
First Submitted That Met QC Criteria
January 8, 2022
First Posted (Actual)
January 21, 2022
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
September 15, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01092 Khowla shah
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.