NCT06317337

Brief Summary

This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

April 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

January 18, 2024

Last Update Submit

March 17, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Borg rating of perceived exertion scale

    The Borg Rating of Perceived Exertion (RPE) scale, developed by Swedish researcher Gunnar Borg, is a tool for measuring an individual's effort and exertion, breathlessness and fatigue during physical work and so is highly relevant for occupational health and safety practice. In its simplest terms, it provides a measure of how hard it feels that the body is working based on the physical sensations that the subject experiences, including increased heart rate, increased respiration or breathing rate, increased sweating and muscle fatigue.

    4 weeks

  • girth

    Anthropometry is the measurement of human body dimension such as girths by using surface landmarks for reference. Like other areas of science the procedures and processes depend upon adherence to the particular rules of measurement as determined by national and international standards bodies. The definitions and instructions in this chapter are consistent with the international anthropometric standards body called the International Society for the Advancement of Kinanthropometry (ISAK).

    4weeks

  • 6min walk test

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity

    4weeks

Study Arms (2)

focused ultrasound cavitation augmented with aerobic exercise

EXPERIMENTAL

Ultrasound cavitation single session per week along with the Aerobic exercises. Aerobic Exercise was Treadmill walk for 30 min with moderate intensity

Other: focused ultrasound cavitation augmented with aerobic exercises

focused ultrasound cavitation

ACTIVE COMPARATOR

Ultrasound cavitation single session per week along with 6min walk test.

Other: focused ultrasound cavitation augmented with aerobic exercises

Interventions

Ultrasound cavitation single session per week along with the Aerobic exercises. Aerobic Exercise was Treadmill walk for 30 min with moderate intensity

focused ultrasound cavitationfocused ultrasound cavitation augmented with aerobic exercise

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with central obesity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females
  • Overweight (Asian BMI scoring)
  • to 40 years of age
  • Central obesity

You may not qualify if:

  • Morbidly obesity
  • Hypertension
  • Arthritis
  • Musculoskeletal disorders
  • Cardiovascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bioflex Aesthetic Clinic

Peshawar, KPK, Pakistan

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria Razzaq, MSCPPT

    Riphah International university Gulberg Greens D block Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

March 19, 2024

Study Start

April 15, 2022

Primary Completion

April 15, 2023

Study Completion

July 15, 2023

Last Updated

March 19, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations