## Protocol Section
### Identification Module
**NCT ID:** NCT00839579

**Brief Title:** Cardiovascular Treatment

**Official Title:** How Little Pain for Cardiac Gain? A Pilot Study

#### Organization Study ID Info
**ID:** 1x4min interval
#### Organization
**Class:** OTHER
**Full Name:** Norwegian University of Science and Technology
### Status Module
#### Completion Date
**Date:** 2010-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-03-07

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-03-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-12

**Type:** ACTUAL

#### Start Date
**Date:** 2009-01

**Status Verified Date:** 2014-03

#### Study First Post Date
**Date:** 2009-02-09
**Type:** ESTIMATED
**Study First Submit Date:** 2009-02-06
**Study First Submit QC Date:** 2009-02-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

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

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Exercise training is proved to protect against premature cardiovascular mortality. Additionally there is evidence that relatively high exercise intensity may be an important factor for improving aerobic capacity and endothelial function in patients with post-infarction heart failure, metabolic syndrome, coronary artery disease, as well as in overweight and obese individuals.

The aim of this study is to investigate the amount of high-intensity exercise needed to improve aerobic capacity and endothelial function.

### Conditions Module

**Conditions:**

- Obesity

**Keywords:**

- slightly overweight

- males 35-45 years

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 26

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 4x4minutes interval group

**Intervention Names:**

- Other: 1x4 min interval

**Label:** 4x4min

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: 1x4 min interval

**Label:** 1x4min

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1x4min

- 4x4min

**Description:** Aerobic interval training

**Name:** 1x4 min interval

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Maximal oxygen consumption and endothelial function

**Time Frame:** baseline and 12 weeks followup

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* BMI: 25-30
* Males, 35-45 years
* Healthy

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 35 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Trondheim

**Country:** Norway

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

**Zip:** 7489

#### Overall Officials

**Official 1:**

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

**Name:** Arnt E Tjønna, PhD

**Role:** STUDY_CHAIR

**Official 2:**

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

**Name:** Ulrik Wisløff, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Tjonna AE, Leinan IM, Bartnes AT, Jenssen BM, Gibala MJ, Winett RA, Wisloff U. Low- and high-volume of intensive endurance training significantly improves maximal oxygen uptake after 10-weeks of training in healthy men. PLoS One. 2013 May 29;8(5):e65382. doi: 10.1371/journal.pone.0065382. Print 2013.

**PMID:** 23734250

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
