## Protocol Section
### Identification Module
**NCT ID:** NCT04288479

**Acronym:** HITFLOW

**Brief Title:** Acute Effects of High Intensity Training in Pregnancy on Fetal Well-being and Blood Flow Distribution

**Official Title:** Acute Effects of HIT on Fetal Well-being and Blood Flow Distribution - a Pilot Study

#### Organization Study ID Info
**ID:** 62993
#### Organization
**Class:** OTHER
**Full Name:** Norwegian University of Science and Technology
### Status Module
#### Completion Date
**Date:** 2025-02

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-02

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-02-23

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2020-02-28
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-26
**Study First Submit QC Date:** 2020-02-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** St. Olavs Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Norwegian University of Science and Technology

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Pregnant women are recommended to be physically active ≥150 min/week, but \<15% of Norwegian women attain this goal. Several well-designed studies on lifestyle interventions focusing primarily on exercise training in overweight/obese pregnant women have reported disappointing outcomes with regard to maternal glycemic control, gestational weight gain and infant outcomes. Low adherence to the training program was found to be a problem; the participants did not enjoy the exercise program and had difficulties scheduling time to exercise. Pregnant women also report that they are not sure what exercises are safe during pregnancy.

High intensity interval training (HIT), defined as short periods of intense activity separated by low-intensity breaks, has proved to induce superior improvements in insulin sensitivity and fitness compared with continuous moderate intensity training in individuals at increased risk for cardiometabolic diseases. Even short-term (6 weeks) HIT with brief (15-60 sec) work-bouts and a total time commitment of \<45 min per week, improves insulin sensitivity similar to that attained after 6 months of traditional endurance training.

HIT is feasible and enjoyable for individuals with low fitness level and with obesity.

HIT is therefore a highly potent intervention that elicits important changes in a range of clinically relevant health outcomes in reproductive-aged women.

This study will investigate fetal responses to a single bout of HIT. Preliminary data of the investigators suggest that HIT does not negatively influence fetal heart rate. Others have reported that uterine and umbilical blood flow are not changed during or following acute exercise. However, no previous study has determined the acute effect of HIT on uterine blood flow and there are no studies investigating the fetal blood flow distribution in response to exercise. Since the relative distribution of blood to the fetal liver is associated with newborn adiposity, fetal blood flow distribution in response to exercise can provide insight about the effect of maternal exercise on offspring health.

### Conditions Module

**Conditions:**

- Pregnancy

**Keywords:**

- Exercise

- High Intensity Interval Training

- Pregnancy Outcome

- Placental Circulation

- Fetal Blood

- Heart Rate, Fetal

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** before-after intervention effect measurement

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Single high-intensity interval training session

**Label:** Doing a single HIT session in gestational week 22-36

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Doing a single HIT session in gestational week 22-36

**Description:** 10 minutes warming up at low-to-moderate intensity, 8x30 seconds high intensity interval training with fetal heart rate measurement after each 30 second work-bout, 2 minutes recovery at low-to-moderate intensity. Continuous monitoring of maternal heart rate.

**Name:** Single high-intensity interval training session

**Other Names:**

- HIT

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** examined by Doppler ultrasound during 30 minutes

**Measure:** blood flow in fetal veins

**Time Frame:** 1 day

**Description:** examined by Doppler ultrasound during 30 minutes

**Measure:** blood flow in fetal arteries

**Time Frame:** 1 day

#### Secondary Outcomes

**Measure:** maternal heart rate

**Time Frame:** 1 dag

**Measure:** Fetal heart rate

**Time Frame:** 1 day

**Measure:** Umbilical vein diameter

**Time Frame:** 1 day

**Measure:** Maternal systolic blood pressure

**Time Frame:** 1 day

**Measure:** Maternal diastolic blood pressure

**Time Frame:** 1 day

**Measure:** Maternal body weight

**Time Frame:** 1 day

**Measure:** Maternal height

**Time Frame:** 1 day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* pregnant, gestational week 22-36
* singleton fetus
* no known diseases
* capable of cycling on an ergometer bike

Exclusion Criteria:

* hypertension
* gestational diabetes mellitus
* any contraindication to exercise training

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** trine.moholdt@ntnu.no

**Name:** Trine Moholdt, phd

**Phone:** +47 73412007

**Role:** CONTACT

**Contact 2:**

**Email:** guro.rosvoldt@ntnu.no

**Name:** Guro Rosvold

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Trondheim

**Contacts:**

***Contact 1:***

- **Email:** trine.moholdt@ntnu.no

- **Name:** Trine Moholdt, phd

- **Role:** CONTACT

**Country:** Norway

**Facility:** Dept Circulation and Medical Imaging, EXCAR Exercise Lab

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** St Olavs Hospital, Dept of Obstetrics and Gynecology

**Name:** Kjell Å Salvesen, md prof

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Norwegian University of Science and Technology

**Name:** Trine Moholdt, phd

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
