search
Back to results

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

Primary Purpose

Postpartum Weight Retention

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nutritional recommendation and Faradic stimulation program
aerobic and resisted exercise for 12 weeks
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Weight Retention focused on measuring exercise, breastfeeding, Overweight, lipid, life quality

Eligibility Criteria

20 Years - 30 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Marwa Gamal Mohamed Ali Anany

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

exercise group

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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)

Full Information

First Posted
October 14, 2023
Last Updated
October 21, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT06098638
Brief Title
Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women
Official Title
Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Weight Retention
Keywords
exercise, breastfeeding, Overweight, lipid, life quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double (participant, outcomes Assessor)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Group (A) included 27 overweight breastfeeding woman who received nutritional recommendation and faradic current stimulation on the abdominal surface for 12 weeks, while group
Arm Title
exercise group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nutritional recommendation and Faradic stimulation program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
aerobic and resisted exercise for 12 weeks
Intervention Description
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
Primary Outcome Measure Information:
Title
measurement of lipid parameter level of High-density lipoprotein (HDL) mg/dL
Description
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.
Time Frame
12 weeks
Title
measurement of Low-density lipoprotein (LDL) mg/dL
Description
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.
Time Frame
12 weeks
Title
measurement of Triglycerides (TG) mg/dL
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
calculation of score of Short Form 36 Health Survey Questionnaire (SF-36) (Arabic version):
Description
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)
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
body mass index (BMI) kg/m²
Description
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
Time Frame
12 weeks
Title
waist to hip ratio (W/H ratio)
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female (overweight breast feeding)
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marwa G anany
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marwa Gamal Mohamed Ali Anany
City
Abū Kabīr
State/Province
Abu Kabir
ZIP/Postal Code
055
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs