Effects of Exercise During Gestation on Maternal and Foetal Health
- Conditions
- Pregnancy
- Interventions
- Other: Exercise intervention
- Registration Number
- NCT02582567
- Lead Sponsor
- Universidad de Granada
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exercise intervention Exercise intervention 3 times per week from the 17th week of gestation until delivery
- Primary Outcome Measures
Name Time Method 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.
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
Neonatal insuline-glucose index At delivery in cord blood samples Neonatal insulin sensitivity will be assessed through the ratio glucose/insulin.
- Secondary Outcome Measures
Name Time Method Bone biomarkers (in mother and cord blood) at 34th week of gestation and at delivery Various relevant biomarkers related to bone metabolism (ACTH, DKK-1, FGF-23, Osteocalcin, OPN-Osteopontin, Osteoprotegerin, PTH and SOST) will be measured with Luminex xMAP technology.
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.
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.
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.
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.
Muscle strength (kg) at the 16th and 34th week of gestation The handgrip strength test will be used as measure of strength
Flexibility (cm) at the 16th and 34th week of gestation The back-scratch test will be used as measure of flexibility
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).
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.
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.
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.
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.
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
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
6-item Female Sexual Function Index at the 16th and 34th week of gestation The 6-item Female Sexual Function Index will be used to assess sex function. This instrument is composed of six questions: desire, arousal, lubrication, orgasm, satisfaction and pain. Each question can be scored from 0 to 5 and then summed up to provide a total score.
Glycaemic profile (in mother and cord blood) at 34th week of gestation and at delivery Plasma glucose, insulin and glycosylated haemoglobinwill be assessed using an autoanalyzer (Hitachi-Roche p800, F. Hoffmann-La Roche Ltd. Switzerland)
Total plasma antioxidant capacity (in mother and cord blood) at 34th week of gestation and at delivery It will be measured by using commercial kit (spectrophotometry).
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.
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.
State Trait Anxiety Index. at the 16th and 34th week of gestation Anxiety levels will be assessed with the State Trait Anxiety Index.
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 .
Positive health at the 16th and 34th week of gestation "Positive health" will be evaluated through the following questionnaires:
1. The Trait Meta-Mood Scale
2. The Positive and Negative Affect Schedule
3. The Satisfaction with Life Scale
4. The 10-item Connor-Davidson Resilience ScaleHaematology at 34th week of gestation and at delivery Erythrocyte count, haematocrit, haemoglobin, platelets, leukocytes and erythrocyte mean corpuscular volume will be quantified by Coulter (Brand).
Lipid profile (in mother and cord blood) at 34th week of gestation and at delivery Plasma total, high-density lipoprotein and low-density lipoprotein cholesterol and triglycerides (all in mg/dL) will be assessed using an autoanalyzer (Hitachi-Roche p800, F. Hoffmann-La Roche Ltd. Switzerland)
Plasma liposoluble antioxidants (in mother and cord blood) at 34th week of gestation and at delivery Plasma vitamin E, retinol, carotene, coenzyme Q10 and coenzyme Q9 will be measured through mass spectrometry
Antioxidant enzymes activity (in mother and cord blood) at 34th week of gestation and at delivery Eritrocite membrane catalase, glutathione peroxidase and superoxide dismutase enzymes will be by measured by spectrophotometry.
Carbonyl proteins (in mother and cord blood) at 34th week of gestation and at delivery Measurement of carbonyl proteins will be done by using commercial kit (spectrophotometry).
Oxidative damage to lipids (in mother and cord blood) at 34th week of gestation and at delivery Measurement of 4-hydroxynonenal and isoprostanes in urine and plasma and hydroperoxides in plasma and erythrocyte membrane by using commercial kits (spectrophotometry and ELISA)
Oxidative damage to DNA (in mother and cord blood) at 34th week of gestation and at delivery measurement of 8-hydroxyguanosine in urine and plasma by commercial kits (ELISA).
Pro- and anti-inflammatory signal (in mother and cord blood) at 34th week of gestation and at delivery Some maternal and umbilical cord plasma pro-inflammatory and anti-inflammatory cytokines (IL-1β, IL-2, IL-6, IL-8, IL-10, IFN-γ and TNF-α, IL-1ra and TNF Srii α), some adipokines (adiponectin, adipsin, resistin, PAI-active, insulin and leptin) and myokines (irisin) will be measured by the employment of Luminex xMAP technology.
Adiposity-related proteins expression (in mother and cord blood) At delivery Glucocorticoid receptor; peroxisome proliferation activated receptor (PPAR); the beta-11 hydroxysteroid dehydrogenase type I (11βHSD1), and beta-11 hydroxysteroid dehydrogenase type II (11βHSD2) will be assessed in maternal and umbilical cord blood and in oral mucosa from the mother and newborn.
Moreover, 4 genes highly involved in foetal and postnatal development of adipose tissue have been selected; two are receptors: the Glucocorticoid receptor and the PPAR-γ, and two are metabolic enzymes: beta-11 hydroxysteroid dehydrogenase type I or 11βHSD1, and 11 beta-hydroxysteroid dehydrogenase type II or 11βHSD2. Of great importance are PPAR-γ1 and PPAR-γ2, which are generated from the same gene by alternative promoter usage and mRNA. We will measure such proteins as well as paraoxonase/arylesterase 1 (PON1) concentrations in maternal and umbilical cord plasma by Polymerase Chain Reaction and Western Blot techniques.
Trial Locations
- Locations (1)
Pilar Cabello-Turmo
🇪🇸Granada, Spain