NCT05202535

Brief 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 cardiovascular disease populations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

January 8, 2022

Last Update Submit

September 15, 2022

Conditions

Keywords

Aerobic exercise, arterial stiffness, hemodynamics, obesity

Outcome Measures

Primary Outcomes (2)

  • Arterial Stiffness

    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

    Factors that govern blood flow calculated through Rate Pressure Product.

    6 weeks

Study Arms (2)

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

Other: Aerobic exercise training

Conventional therapy

ACTIVE COMPARATOR

Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks

Other: Conventional therapy

Interventions

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

Aerobic exercise training

Patient education and counseling with diet plan.Walking 3 days15min/day for 8 weeks

Conventional therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index ≥28 kg/m²
  • Able to do exercise

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Polyclinic Hospital

Islamabad, Punjab Province, 04404, Pakistan

Location

Related Publications (2)

  • Hvidt KN. Blood pressure and arterial stiffness in obese children and adolescents. Dan Med J. 2015 Mar;62(3):B5043.

    PMID: 25748874BACKGROUND
  • 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.

    PMID: 25633314BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mehwish Waseem, MSPT(CPPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2022

First Posted

January 21, 2022

Study Start

November 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations