NCT05219227

Brief Summary

the aim of study is to investigate the effect of laser acupuncture and abdominal exercises on abdominal fat in breast feeding women

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

December 6, 2021

Last Update Submit

September 19, 2022

Conditions

Keywords

obesitylaser acupunctureabdominal exercises

Outcome Measures

Primary Outcomes (3)

  • Effect of laser acupuncture and abdominal exercises on Body fat mass

    Outcome measurement

    1 cycle (42 days)

  • Effect of laser acupuncture and abdominal exercises on Body mass index

    Outcome measurement

    1 cycle (42 days)

  • Effect of laser acupuncture and abdominal exercises on waist girth, hip girth

    Outcome measurement

    1 cycle (42 days)

Study Arms (2)

body fat mass (BFM)

EXPERIMENTAL

body fat mass will be measured before and after interventions

Other: laser acupuncture and abdominal exercises

Body mass index (BMI)

EXPERIMENTAL

BMI will be calculated before and after interventions

Other: laser acupuncture and abdominal exercises

Interventions

laser acupuncture on certain point on the abdomen The following abdominal acupuncture points were irradiated: Cv 8 (Shenque), St 25 (Tianshu, bilateral), and Sp 15 (Daheng , bilateral). The laser irradiations were applied directly to the skin of the points with a perpendicular beam. 478 J/cm2 Abdominal exercises: Types of abdominal exercises: 1. Static abdominal exercises: 2. Dynamic abdominal exercises: * Hip shrugging exercise from crook lying position: * Lateral flexion of the trunk from crook lying position: * Antero-posterior flexion of the trunk from crook lying position:

Body mass index (BMI)body fat mass (BFM)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants are free from any medical problems such as diabetes mellitus, hypertension and thyroid dysfunction.
  • All participants do not use any hormonal contraceptive method.

You may not qualify if:

  • Participants will be excluded if they had diabetes, hypertension, cardiac diseases, patients who had endocrine disease or digestive tract disease and patients with neurological or musculoskeletal disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafar Elsheikh Hospital

Kafr ash Shaykh, 12511, Egypt

Location

MeSH Terms

Conditions

Obesity, AbdominalObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy, basic science department, faculty of physical therapy

Study Record Dates

First Submitted

December 6, 2021

First Posted

February 2, 2022

Study Start

April 1, 2022

Primary Completion

August 1, 2022

Study Completion

September 1, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations