NCT06098638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 14, 2023

Last Update Submit

October 21, 2023

Conditions

Keywords

exercisebreastfeedingOverweightlipidlife quality

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • calculation of score of Short Form 36 Health Survey Questionnaire (SF-36) (Arabic version):

    12 weeks

Other Outcomes (2)

  • body mass index (BMI) kg/m²

    12 weeks

  • waist to hip ratio (W/H ratio)

    12 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

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

exercise group

EXPERIMENTAL

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 programOther: aerobic and resisted exercise for 12 weeks

Interventions

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

control groupexercise group

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

exercise group

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale (overweight breast feeding)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Gamal Mohamed Ali Anany

Abū Kabīr, Abu Kabir, 055, Egypt

Location

MeSH Terms

Conditions

Gestational Weight GainMotor ActivityBreast FeedingOverweight

Condition Hierarchy (Ancestors)

Weight GainBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorFeeding BehaviorOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • marwa G anany

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double (participant, outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist at Abo Kabir general hospital

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 24, 2023

Study Start

January 1, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations