Postpartum Weight RetentionNCT06098638
Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women
A study testing Nutritional recommendation and Faradic stimulation program and aerobic and resisted exercise for 12 weeks in people with Postpartum Weight Retention, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women only
- Conditions the study is for
- Postpartum Weight Retention
- What is being tested?
- Nutritional recommendation and Faradic stimulation program and aerobic and resisted exercise for 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postpartum Weight Retention
- Being tested
- Nutritional recommendation and Faradic stimulation program, aerobic and resisted exercise for 12 weeks
- Keywords
- exercise, breastfeeding, Overweight, lipid, life quality
- Medical subject headings
- Gestational Weight Gain, Motor Activity, Breast Feeding, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional recommendation and Faradic stimulation programOther
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 weeksOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Nutritional recommendation and Faradic stimulation program; Other: aerobic and resisted exercise for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (1)
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Jan 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Weight RetentionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Gamal Mohamed Ali, Cairo University
- Investigators
- marwa G anany, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098638
- Sponsor's protocol ID
- No:P.T.REC/012/004227
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic and Resisted Exercise on Lipid Profile and Quality of Life in Overweight Breastfeeding Women: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06098638
- Acronym / sponsor ID
- No:P.T.REC/012/004227
- Conditions
- Postpartum Weight Retention
- Keywords
- exercise, breastfeeding, Overweight, lipid, life quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Nutritional recommendation and Faradic stimulation programGroup (A) included 27 overweight breastfeeding woman who received nutritional recommendation and faradic current stimulation on the abdominal surface for 12 weeks, while group |
| exercise group | Experimental | Other: Nutritional recommendation and Faradic stimulation program, Other: aerobic and resisted exercise for 12 weeksGroup (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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional recommendation and Faradic stimulation programproper 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 | control group, exercise group |
| aerobic and resisted exercise for 12 weeksEach 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 | Other | exercise group |
Primary outcome
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.
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.
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.
1 secondary outcome
calculation of score of Short Form 36 Health Survey Questionnaire (SF-36) (Arabic version):
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Postpartum Weight Retention
Not yet recruiting
Healthy Adaptation to Pregnancy, Postpartum and Parenthood
Perinatal Mental Health, Gestational Weight Gain
Active, not recruiting
Enhancing Mental and Physical Health of Women Veterans
Cardiovascular Diseases, Overweight
Recruiting
Harvesting Health: Advancing Nutrition and Wellness for Moms and Babies
Pregnant Women With Singleton Pregnancies
Recruiting
Time-restricted Eating for Postpartum Weight Loss
Postpartum Weight Retention, Overweight and Obesity
Recruiting
Healthy for Two-Home Visiting (H42-HV): Health Coaching for Pregnant Women
Postpartum Weight Retention, Pregnancy Weight Gain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marwa G anany principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional recommendation and Faradic stimulation program and aerobic and resisted exercise for 12 weeks in people with Postpartum Weight Retention, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of lipid parameter level of High-density lipoprotein (HDL) mg/dL (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.