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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06098638
Other study ID # No:P.T.REC/012/004227
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date July 31, 2023

Study information

Verified date October 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of the study was to investigate the effect of aerobic and resisted exercise program on lipid profile and quality of life in overweight breastfeeding women.


Description:

Although previous studies reported that exercise training during the postpartum period could improve the lipid profile and quality of life in overweight women and reduce the postpartum fatigue . None of them had investigated the effect of aerobic and resisted exercises on lipid profile and quality of life in overweight breastfeeding women.this trial will include 2 groups: Group (A): was consist of 27 overweight breastfeeding women, who received nutritional recommendation and faradic current stimulation for 20 min on abdominal surface 2 times per week for 12 weeks. Group (B): was consist of 27 overweight breastfeeding women, who received the same nutritional recommendation and faradic current stimulation for 20 min on abdominal surface 2 times per week plus exercise training (aerobic + resisted) for 12 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date July 31, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 30 Years
Eligibility Inclusion Criteria: 1. All of women were sedentary, non-smoking, breastfeeding women at their 3rd to 6th months postpartum 2. they had delivered a single, healthy, mature fetus with no complications through normal vaginal delivery. 3. Their age was ranged from 20 to 30 years old. 4. Their parity number was one or two. 5. They were overweight (body mass index (BMI) was ranged from 25 to 30 kg/m²). Exclusion Criteria: 1. Having chronic disorders, heart disease, respiratory infections, diabetes mellitus, pelvic abnormalities, hormonal abnormalities, psychological problems, menstrual disorders or anemia of other pathological origins. 2. Receiving any type of physical exercise or sport. 3. Following a specific diet program.

Study Design


Intervention

Other:
Nutritional recommendation and Faradic stimulation program
proper maternal nutrition and fluid intake during breast-feeding per day for 12 weeks and2 sessions per week, each session 20 minutes, for 12 weeks. Frequency of 65 Hz, and width pulse 300 ms, with contraction time 10 sec and relaxation time 10 sec
aerobic and resisted exercise for 12 weeks
Each woman in group (B) participated in a moderate exercise program (aerobic+resistive), 3 days/week, for 12 weeks. The session began with 15 minutes of aerobic exercise on a bicycle ergometer, at 60% of heart rate reserve (HRR), with HRR estimated (220-age-resting heart rate). Then, the participant was performed 15 minutes of resistive exercise (two sets of 8-12 repetitions at 75% of one repetition maximum (1-RM) for basic core exercises in the form of hip lifts, knee extension and flexion, crunches, shoulder flexion and extension, elbow flexion and extension with resistance

Locations

Country Name City State
Egypt Marwa Gamal Mohamed Ali Anany Abu Kabir Abu Kabir

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other body mass index (BMI) kg/m² The height and weight were determined for each woman in the both groups (A & B) to calculate her (BMI = (weight in kg)/(height in m^2 ) ) at pre-treatment and post-treatment 12 weeks
Other waist to hip ratio (W/H ratio) The waist and hip circumferences were taken for each woman in both groups (A & B) before and after treatment course for calculating waist and hip ratio (W/H ratio) by dividing waist circumference (WC) on the hip circumference (HC). 12 weeks
Primary measurement of lipid parameter level of High-density lipoprotein (HDL) mg/dL It was used to measure the lipid profile parameters (High-density lipoprotein (HDL)- level in for each woman in the both groups (A & B) at pre-treatment and post-treatment. 12 weeks
Primary measurement of Low-density lipoprotein (LDL) mg/dL It was used to measure the lipid profile parameters Low-density lipoprotein (LDL) level for each woman in the both groups (A & B) at pre-treatment and post-treatment. 12 weeks
Primary measurement of Triglycerides (TG) mg/dL t was used to measure the lipid profile parameters Triglycerides (TG) level for each woman in the both groups (A & B) at pre-treatment and post-treatment. 12 weeks
Secondary calculation of score of Short Form 36 Health Survey Questionnaire (SF-36) (Arabic version): It was assessed using the SF-36 (Arabic version) questionnaire in both groups (A & B) before and after treatment, which consists of 36 questions. Answers were awarded a score in a five-point scale (0-4).Scores for each of the dimensions range from 0 (worst level of functioning) to 4 (best level of functioning) 12 weeks
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