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THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05895435
Collaborator
(none)
60
Enrollment
2
Arms
4.6
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: radiofrequancy
  • Other: aerobic exercise
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
THE EFFECT OF RADIOFREQUENCY ON POSTMENOPAUSAL ADIPOSE TISSUE
Anticipated Study Start Date :
May 31, 2023
Anticipated Primary Completion Date :
Oct 15, 2023
Anticipated Study Completion Date :
Oct 18, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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
Experimental: 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.

Device: 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.

Other: 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

Outcome Measures

Primary Outcome Measures

  1. total cholestrol and HDL and LDL and triglycerides and VLDL by blood analysis [8 week]

    measure before and after tratement programm

Secondary Outcome Measures

  1. waist circumferance using tape measurment [8 week]

    measure before and after tratement

  2. body mass index [8 week]

    measure before and after tratement

  3. weight [8 week]

    measure before and after tratement

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Mahmoud Adel Elasyed Darahem, effect of radiofrequancy on postmenopausal adipose tissue, Cairo University
ClinicalTrials.gov Identifier:
NCT05895435
Other Study ID Numbers:
  • the effect of radiofrequancy
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 8, 2023