Effects of Exercise During Gestation on Maternal and Foetal Health
NCT02582567, Not applicable, Completed, Universidad de Granada
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Exercise During Gestation on Maternal and Foetal Health | ClinicalTrials.gov |
| NCT number | NCT02582567 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 140 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Universidad de Granada | ClinicalTrials.gov |
| Conditions | Pregnancy | ClinicalTrials.gov |
| Interventions | Exercise intervention, Control group | ClinicalTrials.gov |
| First posted | 2015-10-21 | ClinicalTrials.gov |
| Last updated | 2025-11-17 | ClinicalTrials.gov |
Registered outcomes 51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR) | 34th week of gestation | Insulin sensitivity will be derived from the homeostatic model assessment for insulin resistance (HOMA-IR), which will be calculated using the formula \[fasting insulin (μIU/mL) x fasting glucose (mg/dL)\]/405. | ClinicalTrials.gov |
| Primary | Maternal weight gain (kg) | 34th week of gestation | Maternal weight gain will be defined as the weight change from baseline measurement to the last measurement | ClinicalTrials.gov |
| Primary | Neonatal insuline-glucose index | At delivery in cord blood samples | Neonatal insulin sensitivity will be assessed through the ratio glucose/insulin. | ClinicalTrials.gov |
| Secondary | Systolic and diastolic blood pressure (mmHg) | at the 16th and 34th week of gestation | Systolic and diastolic blood pressure (mmHg) will be measured after 5 minutes of rest, on 2 separate occasions (with 2 minutes between trials), with the person seated (Omron Health Care Europe B.V. Hoolddorp). The lowest value of the two trials will be selected for the analysis. | ClinicalTrials.gov |
| Secondary | Resting heart rate (bpm) | at the 16th and 34th week of gestation | Resting heart rate (bpm), will be measured after 5 minutes of rest, on 2 separate occasions (with 2 minutes between trials), with the person seated (Omron Health Care Europe B.V. Hoolddorp). The lowest value of the two trials will be selected for the analysis. | ClinicalTrials.gov |
| Secondary | The Mediterranean Diet Score | at the 16th and 34th week of gestation | The Mediterranean Diet Score in a version adapted to the specific needs during pregnancy for Fe, Ca and folic acid will be used to assess the adherence to the traditional Mediterranean dietary pattern. | ClinicalTrials.gov |
| Secondary | Cardiorespiratory fitness (Vo2max) | at the 16th and 34th week of gestation | The modified Bruce protocol will be performed to estimate maximal oxygen uptake (VO2max), and will be used as measure of cardiorespiratory fitness. | ClinicalTrials.gov |
| Secondary | Cardiorespiratory fitness (meters in the 6-min walk test) | at the 16th and 34th week of gestation | We perform the 6-minute walk test, which measures the maximum distance (in meters) each participant can walk in 6 minutes along a 45.7 m rectangular course. | ClinicalTrials.gov |
| Secondary | Muscle strength (kg) | at the 16th and 34th week of gestation | The handgrip strength test will be used as measure of strength | ClinicalTrials.gov |
| Secondary | Flexibility (cm) | at the 16th and 34th week of gestation | The back-scratch test will be used as measure of flexibility | ClinicalTrials.gov |
| Secondary | Physical activity and sedentary behaviour (in minutes) | at the 16th, 24th and 34th week of gestation | Accelerometry will be used to objectively assess physical activity and sedentary time. Women will be asked to wear a tri-axial accelerometer (ActiSleep+, Pensacola, Florida, United States) for 9 consecutive days, starting the same day they receive the monitor (e.g. participants who receive the accelerometer on Monday, will carry the device until Tuesday of the next week). Participants will be instructed to wear the accelerometer during the whole day (24 hours) on their wrist attached by an elastic belt. Time (in minutes) engaged in light, moderate, and moderate-vigorous intensity PA and sedentary time will be calculated. This accelerometer has been previously used in pregnancy with similar methodology as described in the present protocol. | ClinicalTrials.gov |
| Secondary | Sleep behaviours (through accelerometry) | at the 16th, 24th and 34th week of gestation | Behaviours related to sleep, such as sleep onset, sleep latency, total sleep time, number and duration of awakenings and sleep efficiency will be objectively calculated by using a triaxial accelerometer (ActiSleep+, Pensacola, Florida, United States). The data analysis of such ActiSleep accelerometry data will be carried out through its specific software (Actilife). | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index | at the 16th, 24th and 34th week of gestation | It will be used to assess sleep quality and disturbances over a l-month time interval. | ClinicalTrials.gov |
| Secondary | Insomnia Symptoms Questionnaire | at the 16th, 24th and 34th week of gestation | The presence of symptoms of insomnia will be measured with the Insomnia Symptoms Questionnaire, validated in pregnant women. | ClinicalTrials.gov |
| Secondary | Quality of life (Short-Form Health Survey 36) | at the 16th and 34th week of gestation | We will use the Short-Form Health Survey 36, for assessing health-related quality of life. | ClinicalTrials.gov |
| Secondary | Epidemiological Studies-Depression Scale questionnaire | at the 16th and 34th week of gestation | The pregnant antenatal depression levels will be assessed by the Center for Epidemiological Studies-Depression Scale questionnaire, which is validated and widely employed in pregnancy. | ClinicalTrials.gov |
| Secondary | State Trait Anxiety Index. | at the 16th and 34th week of gestation | Anxiety levels will be assessed with the State Trait Anxiety Index. | ClinicalTrials.gov |
| Secondary | The Detention of Restless Legs Syndrome questionnaire | at the 16th and 34th week of gestation | The "Restless Legs Syndrome" largely determines the quality of life for many pregnant and is related to their levels of depression and sleep quality. The Spanish version of the Detention of Restless Legs Syndrome questionnaire will be employed to assess the presence and severity of this syndrome . | ClinicalTrials.gov |
| Secondary | Oswestry Disability Index score | at the 16th and 34th week of gestation | Low-back pain will be assessed with the Spanish version of the Oswestry Disability Index score | ClinicalTrials.gov |
| Secondary | Pain Visual Analogue Scale | at the 16th and 34th week of gestation | Low-back pain intensity will be also assessed with the Pain Visual Analogue Scale | 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 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 7
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 |
|---|---|---|
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Arithmetic Fluency Task | Secondary outcome | ConductCognition |
| Design Fluency Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
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.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)