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NCT Number: NCT06098638

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

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.

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Key information

Conditions

Postpartum Weight Retention Behavior Body Weight Body Weight Changes Breast Feeding Feeding Behavior Gestational Weight Gain Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Gamal Mohamed Ali Anany

Abū Kabīr, Abu Kabir, 055, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nutritional recommendation and Faradic stimulation program

Other

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

Other

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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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