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Semax

ACTH(4-10) analogue, Heptapeptide SEMAX

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Studies 172
Trials 37
Completed NA INTERVENTIONAL NCT02582567

Effects of Exercise During Gestation on Maternal and Foetal Health

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The main objective of this project is to assess the effects of a novel and supervised exercise intervention in overweight pregnant and their newborn. Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant interested in participate in the intervention program will be randomly assigned to either exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii) physical fitness; iv) objectively measured physical activity and sedentary behaviour; v) sleep quality; vi) mental health, quality of life and positive health; vii) haematology and biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an intention-to-treat basis and per protocol.

Interventions

Name: Exercise intervention
Type: OTHER
Description: The exercise intervention will be performed in two groups so that each group will have 12-13 participants.The groups will train 3 days/week (60min per session) from the 16th week of gestation until delivery. The exercise intervention group will go through different phases of training: a) Learning phase: which will involve the intervention plan, the goals we want to work, and how we will perform it; b) Movement Learning phase: theoretical and practical sessions with the explanation of movements and ergonomic basic patterns; and c) Physical Fitness Training phase: with training sessions aimed at improving fitness and weight loss, and training sessions focused on a correct pelvic mobilization for the delivery.The intensity will be adapted during the exercise program based on the week of gestation and each pregnant heart rate. The sessions will consist of a mixed work, composed of circuits where both muscular and cardiovascular conditioning will be implemented.
Name: Control group
Type: OTHER
Description: Usual care, not exercise.

Primary Outcomes

Measure: Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)
TimeFrame: 34th week of gestation
Description: 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.
Measure: Maternal weight gain (kg)
TimeFrame: 34th week of gestation
Description: Maternal weight gain will be defined as the weight change from baseline measurement to the last measurement
Measure: Neonatal insuline-glucose index
TimeFrame: At delivery in cord blood samples
Description: Neonatal insulin sensitivity will be assessed through the ratio glucose/insulin.

Trial Information

NCT ID

NCT02582567

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Universidad de Granada

Last Updated

December 15, 2025