Trials / Completed
CompletedNCT02582567
Effects of Exercise During Gestation on Maternal and Foetal Health
Effects of Supervised Exercise During Gestation on Maternal and Foetal Health Markers. The GESTAFIT Project
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Universidad de Granada · Academic / Other
- Sex
- Female
- Age
- 25 Years – 40 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Exercise intervention | 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. |
| OTHER | Control group | Usual care, not exercise. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-07-01
- Completion
- 2018-07-01
- First posted
- 2015-10-21
- Last updated
- 2025-11-17
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02582567. Inclusion in this directory is not an endorsement.