NCT01919281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 29, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

July 17, 2013

Last Update Submit

September 28, 2015

Conditions

Polycystic Ovary Syndrome

Keywords

exerciseresistance traininginsulin resistancehigh intensity interval training

Outcome Measures

Primary Outcomes (1)

  • insulin resistance

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

    10 weeks

Secondary Outcomes (3)

  • Body composition

    10 weeks

  • Maximum oxygen uptake

    10 weeks

  • Endothelial function

    10 weeks

Other Outcomes (1)

  • Menstruation diary

    up to 6 months

Study Arms (3)

strength training

EXPERIMENTAL

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.

Behavioral: strength training

interval training

EXPERIMENTAL

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.

Behavioral: interval training

control

NO INTERVENTION

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.

Interventions

strength trainingBEHAVIORAL
Also known as: resistance training
strength training
interval trainingBEHAVIORAL
Also known as: high-intensity exercise, aerobic exercise
interval training

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women
  • Age 18-45 years old
  • PCOS

You may not qualify if:

  • Regular high intensity endurance or strength training (two or more times per week of vigorous exercise).
  • On-going pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of circulation and medical imaging , NTNU

Trondheim, 7491, Norway

Location

Related Publications (1)

  • 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.

    PMID: 26406234RESULT

MeSH Terms

Conditions

Polycystic Ovary SyndromeMotor ActivityInsulin Resistance

Interventions

Resistance TrainingHigh-Intensity Interval TrainingExercise

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Trine Moholdt, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

August 8, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2014

Study Completion

April 1, 2015

Last Updated

September 29, 2015

Record last verified: 2015-05

Locations

NO(1)