Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women
October 21, 2023 updated by: Marwa Gamal Mohamed Ali, Cairo University
Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women: A Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Abu Kabir
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Abū Kabīr, Abu Kabir, Egypt, 055
- Marwa Gamal Mohamed Ali Anany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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
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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
|
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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.
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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
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measurement of lipid parameter level of High-density lipoprotein (HDL) mg/dL
Time Frame: 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.
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12 weeks
|
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measurement of Low-density lipoprotein (LDL) mg/dL
Time Frame: 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.
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12 weeks
|
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measurement of Triglycerides (TG) mg/dL
Time Frame: 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.
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
calculation of score of Short Form 36 Health Survey Questionnaire (SF-36) (Arabic version):
Time Frame: 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)
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12 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body mass index (BMI) kg/m²
Time Frame: 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
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12 weeks
|
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waist to hip ratio (W/H ratio)
Time Frame: 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).
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: marwa G anany, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
October 14, 2023
First Submitted That Met QC Criteria
October 21, 2023
First Posted (Actual)
October 24, 2023
Study Record Updates
Last Update Posted (Actual)
October 24, 2023
Last Update Submitted That Met QC Criteria
October 21, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- No:P.T.REC/012/004227
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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