HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children
NCT05009433, Not applicable, Recruiting, Gdansk University of Physical Education and Sport
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children | ClinicalTrials.gov |
| NCT number | NCT05009433 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 600 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Gdansk University of Physical Education and Sport | ClinicalTrials.gov |
| Conditions | Pregnancy, Postpartum, Childbirth, Health Status, Physical Fitness, Noncommunicable Diseases, Metabolism, Diabetes Mellitus, Gestational, Pregnancy Induced Hypertension, Body Composition, Back Pain, Pain Threshold, Biomechanics, Pelvic Floor Disorders, Urinary Incontinence, Cognitive Function, Depression, Anxiety | ClinicalTrials.gov |
| Interventions | High intensity interval training program for pregnant women, Moderate intensity continuous training program for pregnant women, Standard obstetric care with extended education on healthy lifestyle, High intensity interval training program for nonpregnant women, Moderate intensity continuous training program for nonpregnant women, Standard health care with extended education on healthy lifestyle | ClinicalTrials.gov |
| First posted | 2021-08-17 | ClinicalTrials.gov |
| Last updated | 2022-12-02 | ClinicalTrials.gov |
Registered outcomes 93
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in maternal oxygen consumption, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes from the baseline maternal oxygen consumption (VO2; ml/min), including the maximal oxygen consumption (VO2max) values in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using stationary respiratory gas analyzer. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. | ClinicalTrials.gov |
| Primary | Changes in maternal heart rate, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes from the baseline heart rate (HR; beats per minute), including the maximal HR values, in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using heart rate monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. | ClinicalTrials.gov |
| Primary | Changes in systolic blood pressure, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes from the baseline maternal systolic blood pressure (SBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. | ClinicalTrials.gov |
| Primary | Changes in diastolic blood pressure, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes from the baseline maternal diastolic blood pressure (DBP; mm Hg), in a progressive maximal exercise test on a cycloergometer with electronically regulated load, using electronic blood pressure monitor. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters. | ClinicalTrials.gov |
| Primary | Changes in blood glucose level, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | To assess the changes in glucose levels (mg/dl) the blood samples will be taken on the day of the maximal exercise capacity test before the test (at fasting condition), immediately (approx. 1 min) after completion the test and approx. 40 min. after the test. The investigators will analyze changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in triglycerides, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes in triglycerides (TG; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in high-density lipoproteins, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes in high-density lipoproteins (HDL; mg/dl) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially related to metabolism and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in urea, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | To assess the changes in urea levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in creatinine, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | To assess the changes in creatinine levels (ml/dl), the study participants will collect urine samples to standard urine containers on the day of the maximal exercise capacity test before the test (at fasting condition), immediately after completion the test (up to 15 min) and approx. 60 min after the test. The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially related to renal function and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in maternal weight, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes in maternal weight will be expressed in kilograms (kg). The investigators will analyze the changes in this parameter in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in maternal Body Mass Index during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | Changes in Body Mass Index (BMI, kg/m2) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in maternal neuromuscular activity of pelvic floor muscles, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The neuromuscular activity of pelvic floor muscles (µV) will be evaluated with surface electromyography with a vaginal probe, in the condition of synergistic muscle relaxation. The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in the Incontinence Impact Questionnaire score, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The urinary incontinence symptoms will be assessed using the scale of incontinence impact on the quality of life based on the Incontinence Impact Questionnaire - short form (Uebersax et al., 1995; IIQ-7 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in the Urogenital Distress Inventory score, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The pelvic floor disorders will be assessed using the scale based on the Urogenital Distress Inventory - short form questionnaire (Uebersax et al., 1995; UDI - 6 score; minimum score: 0; maximum score: 100; higher scores mean worse outcome). The investigators will analyze the changes in this outcome in terms of intervention mode and its relationship with other selected parameters, potentially related to pelvic floor function and changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in the inter-rectus distance, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The changes in the inter-rectus distance (IRD, mm) will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in the center of pressure excursions (static balance), during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The changes in the excursions of the center of pressure (COP; mm) will be measured in standing position using a specialized force platform. The changes in the static balance will be analyzed in terms of intervention mode and its relationship with other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in lumbar spine mobility, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The changes in the lumbar spine mobility (°) will be measured in standing position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in cervical spine mobility, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The changes in the cervical spine mobility (°) will be measured in sitting position using specialized motion detectors and software. The changes lumbar spine mobility will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in foot loading, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The changes in foot loading (kPa) will be measured in standing position using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
| Primary | Changes in spatiotemporal gait parameters: step length, during and after pregnancy | Before starting the intervention and after the completion of each training or educational cycle (during the first 8 months or until birth each training or education cycle lasts 8 weeks; during the next 12 months each cycle lasts 3 months). | The changes in the step length (m) will be measured in walking using plantar pressure measurements platform and software. This outcome will be analyzed in terms of intervention mode and in relation to other selected parameters, potentially changing with regular exercise in the perinatal period. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 24
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 26566220 | BACKGROUND | PubMed |
| 27127296 | BACKGROUND | PubMed |
| 27417194 | BACKGROUND | PubMed |
| 27733352 | BACKGROUND | PubMed |
| 28642221 | BACKGROUND | PubMed |
| 29226153 | BACKGROUND | PubMed |
| 30337349 | BACKGROUND | PubMed |
| 30337463 | BACKGROUND | PubMed |
| 30337464 | BACKGROUND | PubMed |
| 30337466 | BACKGROUND | PubMed |
| 30761019 | BACKGROUND | PubMed |
| 30944566 | BACKGROUND | PubMed |
| 31095079 | BACKGROUND | PubMed |
| 32023833 | BACKGROUND | PubMed |
| 32028397 | BACKGROUND | PubMed |
| 32217980 | BACKGROUND | PubMed |
| 33040592 | BACKGROUND | PubMed |
| 33098219 | BACKGROUND | PubMed |
| 33139602 | BACKGROUND | PubMed |
| 33239350 | BACKGROUND | PubMed |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.