ObesityNCT05202535
Effect of Aerobic Exercise Training in Obese Adults
A study testing Aerobic exercise training and Conventional therapy in people with Obesity, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Aerobic exercise training and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index ≥28 kg/m²
- Able to do exercise
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Aerobic exercise training, Conventional therapy
- Keywords
- Aerobic exercise, arterial stiffness, hemodynamics, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise trainingOther
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
Conventional therapyOther
Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise training | Experimental | 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 Receives: Other: Aerobic exercise training |
| Conventional therapy | Active comparator | Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Stiffness
Gradual fragmentation and loss of elastin fibers and accumulation of stiffer collagen fibers in the arterial wall. Calculated through Arterial stiffness index.
Measured: 6 weeks
Hemodynamics
Factors that govern blood flow calculated through Rate Pressure Product.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Nov 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Waseem, MSPT(CPPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202535
- Sponsor's protocol ID
- REC/01092 Khowla shah
- Status last verified
- Sep 2022
- First submitted
- 8 Jan 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hvidt KN. Blood pressure and arterial stiffness in obese children and adolescents. Dan Med J. 2015 Mar;62(3):B5043.
PubMed 25748874Cote 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.
PubMed 25633314
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Training on Arterial Stiffness and Hemodynamics in Obese Adults.
- ClinicalTrials.gov ID
- NCT05202535
- Acronym / sponsor ID
- REC/01092 Khowla shah
- Conditions
- Obesity
- Keywords
- Aerobic exercise, arterial stiffness, hemodynamics, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise training | Experimental | Other: Aerobic exercise traininghospital-based aerobic exercise training on treadmill/cycle ergometer with the intensity of 40-70% of HR max, for 15-30 mints for 8 weeks |
| Conventional therapy | Active comparator | Other: Conventional therapyPatient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index ≥28 kg/m²
- Able to do exercise
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise trainingHospital-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 | Other | Aerobic exercise training |
| Conventional therapyPatient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks | Other | Conventional therapy |
Primary outcome
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.
Hemodynamics
Time frame: 6 weeks
Factors that govern blood flow calculated through Rate Pressure Product.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 25748874Hvidt KN. Blood pressure and arterial stiffness in obese children and adolescents. Dan Med J. 2015 Mar;62(3):B5043.
- Background: PubMed 25633314Cote 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehwish Waseem, MSPT(CPPT) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise training and Conventional therapy in people with Obesity, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial Stiffness (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202535, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.