THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE

NCT ID: NCT05895435

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2023-10-18

Brief Summary

• Menopause is associated with a redistribution of adipose tissue towards central adiposity, known to cause insulin resistance. It was found that menopause was associated with changes in adipose tissue phenotype related to metabolic dysfunction. In subcutaneous adipose tissue (SAT)
• The radiofrequency uses high-frequency electromagnetic waves to produce heat at the cutaneous and the subcutaneous levels. The mechanism of action, through the vibration of water molecules, transforms the electromagnetic energy into thermal. The heat generated by conversion occurs under 30 kHz to 300 MHz, and the most frequently used frequency is set between 0.5 and 1.5 MHz. The RF mechanism of fat reduction occurs by the generation of thermal stimulation of adipocyte metabolism, occurring through enzymatic degradation by lipase-mediated triglycerides, apoptosis, and adipocyte rupture and the objective of study to show the positive effect of radiofrequancy on postmenopausal adipose tissue

Detailed Description

About 90% of menopausal women experience some amount of weight gain. It is a natural and common aspect of getting older. It occurs because the body mass increases, as a result of fat deposits. However, weight gain associated with menopause typically involves increased amounts of fat around the abdomen. On an average, women gain between 8-10 kilogram between the ages of 45 and 55, the stage in life when menopause occurs. This extra weight generally does not evenly distribute itself throughout a woman's body. The weight tends instead to accumulate around the abdomen or thighs (Singh et al., 2013).

Postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and android fat redistribution it is mostly attributed to estrogen depletion though other factors such as chronological aging and decline in physical activity play a significant role. The deleterious health consequences of obesity and visceral fat deposition after menopause encompass a variety of problems; from dyslipidemia and metabolic syndrome to increased risk of cardiovascular disease (CVD), osteoporosis, malignancies and mortality (Stachowiak et al., 2015) This emphasizes the need of effective methods for treating central adiposity in post-menopausal woman. No prior studies have investigated the effect of radiofrequency on adipose tissue. So this may add a new physical therapy method for treating this problem.

Conditions

Show Positive Effect of Radiofrequancy on Postmenopausal Adipose Tissue

Study Design

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

Study Groups

first group

Group (A) (Control Group):

It will be consisted of 30 patients who will receive aerobic exercise and diet for 8 successive weeks 2 sessions per week.

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: OTHER

The program include five minutes for warming-up in the form of range of motion and stretching exercises, thirty minutes of walking on treadmill with high speed (60-70% of maximum heart rate) and five minutes of cooling down (on treadmill with low speed and without inclination

second group

Group (B) (Study Group):

It will be consisted of 30 patients who will receive aerobic exercise and diet and radiofrequency for 8 successive weeks 2 sessions per week.

Group Type: EXPERIMENTAL

radiofrequancy

Intervention Type: DEVICE

• Power of device: 150 W
• Duration of the session: 40 minutes
• Frequency: 2 sessions per week for 8 week.
• Heating temperature: According to patient tolerance.

aerobic exercise

Intervention Type: OTHER

The program include five minutes for warming-up in the form of range of motion and stretching exercises, thirty minutes of walking on treadmill with high speed (60-70% of maximum heart rate) and five minutes of cooling down (on treadmill with low speed and without inclination

Interventions

radiofrequancy

• Power of device: 150 W
• Duration of the session: 40 minutes
• Frequency: 2 sessions per week for 8 week.
• Heating temperature: According to patient tolerance.

Intervention Type: DEVICE

aerobic exercise

The program include five minutes for warming-up in the form of range of motion and stretching exercises, thirty minutes of walking on treadmill with high speed (60-70% of maximum heart rate) and five minutes of cooling down (on treadmill with low speed and without inclination

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1-Their ages will be ranged from 45 to 60 years 2- BMI > 25 kg/m² and < 35 kg/m². 3- Waist circumference more than 88cm

Exclusion Criteria

• 1-Cancer. 2-Renal failure 3-tumors 4-Hepatic diseases 5-skin disease that prevent the use of radiofrequancy

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Adel Elasyed Darahem

effect of radiofrequancy on postmenopausal adipose tissue

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

mahmoud adel darahem

Role: CONTACT

mahmouddarahem2023@gamil.com

01028911100

afaf mohamed botla

Role: CONTACT

drafafmohamed@cu.edu.eg

01283126608

References

Guthrie JR, Dennerstein L, Taffe JR, Donnelly V. Health care-seeking for menopausal problems. Climacteric. 2003 Jun;6(2):112-7.

Reference Type: BACKGROUND

PMID: 12841881 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Related Links

https://www.who.int/news-room/fact-sheets/detail/menopause

data obtain through the study may be provided to a qualified resarcher

Other Identifiers

the effect of radiofrequancy

Identifier Type: -

Identifier Source: org_study_id