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High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
strength training
interval training
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring exercise, resistance training, insulin resistance, high intensity interval training

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women
  • Age 18-45 years old
  • PCOS

Exclusion Criteria:

  • Regular high intensity endurance or strength training (two or more times per week of vigorous exercise).
  • Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
  • On-going pregnancy.

Sites / Locations

  • Department of circulation and medical imaging , NTNU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

strength training

interval training

control

Arm Description

The subjects will attend for supervised training three sessions per week for 10 weeks (9-12). The strength training program involves dynamic contraction at intensities of 60 - 70 % of 1 repetition maximum (RM) to improve strength and muscle hypertrophy. Each session will contain 8 exercises on the major muscle groups. Each drill consists of 10-12 repetitions (reps) x 3 sets separated by one minute rest between sets.

High intensity interval training (HIT) three times per week. The three weekly supervised HIT sessions will include two 4x4 min interval sessions and one 10x1 min session. The HIT consist of "uphill" treadmill running/walking.

Based on the Norwegian recommendation we will encourage the control group to perform 60 minutes of physical activity at moderate to high intensity on a daily basis.

Outcomes

Primary Outcome Measures

insulin resistance
measured with the homeostatic model assessment for insulin resistance (HOMA-IR) method

Secondary Outcome Measures

Body composition
Measured as body fat % on an impedance scale and waist circumference
Maximum oxygen uptake
Measured during maximum effort exercise test
Endothelial function
Flow mediated dilatation of the brachial artery.

Full Information

First Posted
July 17, 2013
Last Updated
September 28, 2015
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01919281
Brief Title
High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome
Official Title
High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim is to investigate whether strength training or high intensity interval training is effective in improving insulin sensitivity, cardiovascular outcomes, body composition and reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS). Few studies have examined the effect of strength training alone on insulin sensitivity, reproductive outcomes and body composition in women with PCOS. Most previous studies on aerobic exercise in PCOS have applied moderate exercise intensity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
exercise, resistance training, insulin resistance, high intensity interval training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
strength training
Arm Type
Experimental
Arm Description
The subjects will attend for supervised training three sessions per week for 10 weeks (9-12). The strength training program involves dynamic contraction at intensities of 60 - 70 % of 1 repetition maximum (RM) to improve strength and muscle hypertrophy. Each session will contain 8 exercises on the major muscle groups. Each drill consists of 10-12 repetitions (reps) x 3 sets separated by one minute rest between sets.
Arm Title
interval training
Arm Type
Experimental
Arm Description
High intensity interval training (HIT) three times per week. The three weekly supervised HIT sessions will include two 4x4 min interval sessions and one 10x1 min session. The HIT consist of "uphill" treadmill running/walking.
Arm Title
control
Arm Type
No Intervention
Arm Description
Based on the Norwegian recommendation we will encourage the control group to perform 60 minutes of physical activity at moderate to high intensity on a daily basis.
Intervention Type
Behavioral
Intervention Name(s)
strength training
Other Intervention Name(s)
resistance training
Intervention Type
Behavioral
Intervention Name(s)
interval training
Other Intervention Name(s)
high-intensity exercise, aerobic exercise
Primary Outcome Measure Information:
Title
insulin resistance
Description
measured with the homeostatic model assessment for insulin resistance (HOMA-IR) method
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
Measured as body fat % on an impedance scale and waist circumference
Time Frame
10 weeks
Title
Maximum oxygen uptake
Description
Measured during maximum effort exercise test
Time Frame
10 weeks
Title
Endothelial function
Description
Flow mediated dilatation of the brachial artery.
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Menstruation diary
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women Age 18-45 years old PCOS Exclusion Criteria: Regular high intensity endurance or strength training (two or more times per week of vigorous exercise). Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion). On-going pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of circulation and medical imaging , NTNU
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26406234
Citation
Almenning I, Rieber-Mohn A, Lundgren KM, Shetelig Lovvik T, Garnaes KK, Moholdt T. Effects of High Intensity Interval Training and Strength Training on Metabolic, Cardiovascular and Hormonal Outcomes in Women with Polycystic Ovary Syndrome: A Pilot Study. PLoS One. 2015 Sep 25;10(9):e0138793. doi: 10.1371/journal.pone.0138793. eCollection 2015.
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High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome

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