Effects of Exercise During Gestation on Maternal and Foetal Health

Pregnancy Clinical Trial

— GESTAFIT  

Official title:

Effects of Supervised Exercise During Gestation on Maternal and Foetal Health Markers. The GESTAFIT Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582567
• Other study ID #: GESTAFIT
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: July 2018

Study information

• Verified date: September 2019
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion criteria:

• Overweight pregnant woman with a normal pregnancy course.

• Answer "no" to all questions on the PARmed-X for pregnancy*.

• To be able to walk without assistance.

• To be able to read and write enough.

• Informed consent: To be capable and willing to provide consent. *In addition, specific inclusion criteria for data analysis are: gestational age at delivery of 37-42 weeks with single foetus, spontaneous vaginal delivery or instrumental vaginal and caesarean without maternofoetal pathology (or other indication that does not involve maternofoetal risk, such as disproportion, failed induction, no foetal progression or non-cephalic presentation), newborn with appropriate weight, Apgar score>7 in the 1st and 5th minute of life, cord blood pH (normal>7.20) and normal monitoring results.

Exclusion criteria:

• Acute or terminal illness.

• Malnutrition.

• Inability to conduct tests for assessing physical fitness or exercise during pregnancy.

• Underweight, normal-weight or obesity.

• Pregnancy risk factors (such as hypertension, type 2 diabetes, etc.).

• Multiple pregnancies.

• Chromosopathy or foetal malformations.

• Uterine growth restriction.

• Foetal death.

• Upper or lower extremity fracture in the past 3 months.

• Presence of neuromuscular disease or drugs affecting neuromuscular function

• Be registered in other exercise program

• Perform more than 300 minutes of at least moderate physical activity per week

• Unwillingness to either complete the study requirements or to be randomised into control or intervention group.

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Spain	Pilar Cabello-Turmo	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity derived from the homeostatic model assessment for insulin resistance (HOMA-IR)	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.	34th week of gestation
Primary	Maternal weight gain (kg)	Maternal weight gain will be defined as the weight change from baseline measurement to the last measurement	34th week of gestation
Primary	Neonatal insuline-glucose index	Neonatal insulin sensitivity will be assessed through the ratio glucose/insulin.	At delivery in cord blood samples
Secondary	Systolic and diastolic blood pressure (mmHg)	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.	at the 16th and 34th week of gestation
Secondary	Resting heart rate (bpm)	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.	at the 16th and 34th week of gestation
Secondary	The Mediterranean Diet Score	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.	at the 16th and 34th week of gestation
Secondary	Cardiorespiratory fitness (Vo2max)	The modified Bruce protocol will be performed to estimate maximal oxygen uptake (VO2max), and will be used as measure of cardiorespiratory fitness.	at the 16th and 34th week of gestation
Secondary	Cardiorespiratory fitness (meters in the 6-min walk test)	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.	at the 16th and 34th week of gestation
Secondary	Muscle strength (kg)	The handgrip strength test will be used as measure of strength	at the 16th and 34th week of gestation
Secondary	Flexibility (cm)	The back-scratch test will be used as measure of flexibility	at the 16th and 34th week of gestation
Secondary	Physical activity and sedentary behaviour (in minutes)	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.	at the 16th, 24th and 34th week of gestation
Secondary	Sleep behaviours (through accelerometry)	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).	at the 16th, 24th and 34th week of gestation
Secondary	Pittsburgh Sleep Quality Index	It will be used to assess sleep quality and disturbances over a l-month time interval.	at the 16th, 24th and 34th week of gestation
Secondary	Insomnia Symptoms Questionnaire	The presence of symptoms of insomnia will be measured with the Insomnia Symptoms Questionnaire, validated in pregnant women.	at the 16th, 24th and 34th week of gestation
Secondary	Quality of life (Short-Form Health Survey 36)	We will use the Short-Form Health Survey 36, for assessing health-related quality of life.	at the 16th and 34th week of gestation
Secondary	Epidemiological Studies-Depression Scale questionnaire	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.	at the 16th and 34th week of gestation
Secondary	State Trait Anxiety Index.	Anxiety levels will be assessed with the State Trait Anxiety Index.	at the 16th and 34th week of gestation
Secondary	The Detention of Restless Legs Syndrome questionnaire	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 .	at the 16th and 34th week of gestation
Secondary	Oswestry Disability Index score	Low-back pain will be assessed with the Spanish version of the Oswestry Disability Index score	at the 16th and 34th week of gestation
Secondary	Pain Visual Analogue Scale	Low-back pain intensity will be also assessed with the Pain Visual Analogue Scale	at the 16th and 34th week of gestation
Secondary	6-item Female Sexual Function Index	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.	at the 16th and 34th week of gestation
Secondary	Positive health	"Positive health" will be evaluated through the following questionnaires: The Trait Meta-Mood Scale; The Positive and Negative Affect Schedule; The Satisfaction with Life Scale; The 10-item Connor-Davidson Resilience Scale	at the 16th and 34th week of gestation
Secondary	Haematology	Erythrocyte count, haematocrit, haemoglobin, platelets, leukocytes and erythrocyte mean corpuscular volume will be quantified by Coulter (Brand).	at 34th week of gestation and at delivery
Secondary	Lipid profile (in mother and cord blood)	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)	at 34th week of gestation and at delivery
Secondary	Glycaemic profile (in mother and cord blood)	Plasma glucose, insulin and glycosylated haemoglobinwill be assessed using an autoanalyzer (Hitachi-Roche p800, F. Hoffmann-La Roche Ltd. Switzerland)	at 34th week of gestation and at delivery
Secondary	Total plasma antioxidant capacity (in mother and cord blood)	It will be measured by using commercial kit (spectrophotometry).	at 34th week of gestation and at delivery
Secondary	Plasma liposoluble antioxidants (in mother and cord blood)	Plasma vitamin E, retinol, carotene, coenzyme Q10 and coenzyme Q9 will be measured through mass spectrometry	at 34th week of gestation and at delivery
Secondary	Antioxidant enzymes activity (in mother and cord blood)	Eritrocite membrane catalase, glutathione peroxidase and superoxide dismutase enzymes will be by measured by spectrophotometry.	at 34th week of gestation and at delivery
Secondary	Carbonyl proteins (in mother and cord blood)	Measurement of carbonyl proteins will be done by using commercial kit (spectrophotometry).	at 34th week of gestation and at delivery
Secondary	Oxidative damage to lipids (in mother and cord blood)	Measurement of 4-hydroxynonenal and isoprostanes in urine and plasma and hydroperoxides in plasma and erythrocyte membrane by using commercial kits (spectrophotometry and ELISA)	at 34th week of gestation and at delivery
Secondary	Oxidative damage to DNA (in mother and cord blood)	measurement of 8-hydroxyguanosine in urine and plasma by commercial kits (ELISA).	at 34th week of gestation and at delivery
Secondary	Pro- and anti-inflammatory signal (in mother and cord blood)	Some maternal and umbilical cord plasma pro-inflammatory and anti-inflammatory cytokines (IL-1ß, IL-2, IL-6, IL-8, IL-10, IFN-? and TNF-a, IL-1ra and TNF Srii a), some adipokines (adiponectin, adipsin, resistin, PAI-active, insulin and leptin) and myokines (irisin) will be measured by the employment of Luminex xMAP technology.	at 34th week of gestation and at delivery
Secondary	Bone biomarkers (in mother and cord blood)	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.	at 34th week of gestation and at delivery
Secondary	Adiposity-related proteins expression (in mother and cord blood)	Glucocorticoid receptor; peroxisome proliferation activated receptor (PPAR); the beta-11 hydroxysteroid dehydrogenase type I (11ßHSD1), and beta-11 hydroxysteroid dehydrogenase type II (11ßHSD2) 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-?, and two are metabolic enzymes: beta-11 hydroxysteroid dehydrogenase type I or 11ßHSD1, and 11 beta-hydroxysteroid dehydrogenase type II or 11ßHSD2. Of great importance are PPAR-?1 and PPAR-?2, 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.	At delivery