Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT06098638

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Weight Retention	Other: Nutritional recommendation and Faradic stimulation program Other: aerobic and resisted exercise for 12 weeks	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel assignmentparallel assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

double (participant, outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women: A Randomized Clinical Trial

Actual Study Start Date :

Jan 1, 2023

Actual Primary Completion Date :

Jul 31, 2023

Actual Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group Group (A) included 27 overweight breastfeeding woman who received nutritional recommendation and faradic current stimulation on the abdominal surface for 12 weeks, while group	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
Experimental: exercise group Group (B) 27 overweight breastfeeding women, who received the same nutritional recommendation and faradic current stimulation on the abdominal surface plus exercise training (aerobic + resisted) for 12 weeks.	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 Other: 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

Arm

Intervention/Treatment

Active Comparator: control group

Group (A) included 27 overweight breastfeeding woman who received nutritional recommendation and faradic current stimulation on the abdominal surface for 12 weeks, while group

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

Experimental: exercise group

Group (B) 27 overweight breastfeeding women, who received the same nutritional recommendation and faradic current stimulation on the abdominal surface plus exercise training (aerobic + resisted) for 12 weeks.

Other: Nutritional recommendation and Faradic stimulation program

Other: 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

Outcome Measures

Primary Outcome Measures

measurement of lipid parameter level of High-density lipoprotein (HDL) mg/dL [12 weeks]
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.
measurement of Low-density lipoprotein (LDL) mg/dL [12 weeks]
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.
measurement of Triglycerides (TG) mg/dL [12 weeks]
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.

Secondary Outcome Measures

calculation of score of Short Form 36 Health Survey Questionnaire (SF-36) (Arabic version): [12 weeks]
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)

Other Outcome Measures

body mass index (BMI) kg/m² [12 weeks]
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
waist to hip ratio (W/H ratio) [12 weeks]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

All of women were sedentary, non-smoking, breastfeeding women at their 3rd to 6th months postpartum
they had delivered a single, healthy, mature fetus with no complications through normal vaginal delivery.
Their age was ranged from 20 to 30 years old.
Their parity number was one or two.
They were overweight (body mass index (BMI) was ranged from 25 to 30 kg/m²).

Exclusion Criteria:

Having chronic disorders, heart disease, respiratory infections, diabetes mellitus, pelvic abnormalities, hormonal abnormalities, psychological problems, menstrual disorders or anemia of other pathological origins.
Receiving any type of physical exercise or sport.
Following a specific diet program.