Focused Ultrasound Cavitation Augmented With Aerobic Exercise

NCT ID: NCT06317337

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2023-07-15

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.

Detailed Description

Abdominal obesity can be treated through invasive and non-invasive procedures. The most common invasive protocol is surgical liposuction, this is mostly useful for removing large volume of fat. Nonsurgical approaches included exercises and selective focus energy which target the subcutaneous adipose tissue including focused ultrasound. Focus ultrasound produce cavitation which results in fat cell lysis through mechanical energy without causing any harmful effect on surrounding nerves and connective tissue.

There is an increasing demand for noninvasive fat reduction methods; there is variety of physical treatments in practice for localized fat reduction such as electrical stimulation, mechanical massage, light based therapies and cold low level laser irradiation but clinically most of them failed to meet expectations. Literature reported that clinically High Intensity Focused Ultrasound (HIFU) is most effective for noninvasive fat reduction therapy. Ultrasound causes cavitation phenomena on fat droplet watery cytoplasm interface and eventually rupture of adipocytes and triglycerides release, this whole phenomena is caused through generation of compression and decompression cycle at specific frequency. Ultrasound Fat cavitation is the technique of handling obesity, specially by destroying fat and shaping a body part. There is a limited literature available on effects of aerobic exercises and focused ultrasound cavitation on obesity but there was no literature available on combine effects of both treatments. 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.

Conditions

Central Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

focused ultrasound cavitation augmented with aerobic exercise

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

Group Type: EXPERIMENTAL

focused ultrasound cavitation augmented with aerobic exercises

Intervention Type: OTHER

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

focused ultrasound cavitation

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

Group Type: ACTIVE_COMPARATOR

focused ultrasound cavitation augmented with aerobic exercises

Intervention Type: OTHER

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

Interventions

focused ultrasound cavitation augmented with aerobic exercises

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Razzaq, MSCPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International university Gulberg Greens D block Islamabad

Locations

Bioflex Aesthetic Clinic

Peshawar, KPK, Pakistan

Countries

Pakistan

Other Identifiers

Sana Bshir

Identifier Type: -

Identifier Source: org_study_id