Effect of Exercise on Cardiometabolic Profile in Women With Polycystic Ovary Syndrome

Sheffield Hallam University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Behavioral: Lifestyle Physical Activity; Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03678714

ER6262197

Details and patient eligibility

About

Polycystic Ovary Syndrome (PCOS) is a complex hormonal and metabolic disorder that has been shown to affect women's fertility. It can also share many symptoms with pre-diabetes, and women with PCOS often have an increased risk for type 2 diabetes, heart attack and stroke.

This study aims to assess the feasibility and acceptability of exercise intervention and increased lifestyle physical activity to improve cardiovascular disease risk factors in women with PCOS.

Full description

This is a three arm feasibility study in which participants will be allocated to an exercise group, an increased lifestyle physical activity group, or a control group. We will determine the appropriateness of procedures for recruitment, allocation, measurement and retention for the intervention procedures in women with polycystic ovary syndrome.

The investigators will also determine if we are able to detect changes in blood lipid profile, inflammation, and hormonal and metabolic profile as a result of the intervention(s) using blood biomarkers.

Enrollment: 37 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women diagnosed with PCOS according to the Rotterdam Criteria 2003, National Institute of Health (NIH) 1990 criteria or Androgen Excess and Polycystic Ovary Syndrome (AE-PCOS) Society 2006 criteria.
• Have experienced menarche (their first menstrual bleeding) and be at least 18 years of age.
• Are English speaking.
• Are physically able to perform exercise.

Exclusion criteria

• Post-menopausal status.
• Are smokers.
• Are undertaking regular structured exercise defined as >150min/week.
• Have been taking metformin for less than three months.
• Are taking the oral contraceptive pill (OCP) or have taken in the last month.
• Have any medical condition that may be responsible for the symptoms of PCOS, such as congenital hyperplasia, androgen-secreting tumour, hyperprolactinemia, or Cushing's syndrome.
• Have current cardiovascular disease or a history of cardiac events.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 3 patient groups

Exercise Intervention

Experimental group

Description:

Structured exercise intervention will be undertaken for 12 weeks

Treatment:

Behavioral: Exercise Intervention

Lifestyle Physical Activity

Experimental group

Description:

Increased lifestyle physical activity undertaken for 12 weeks

Treatment:

Behavioral: Lifestyle Physical Activity

Control

No Intervention group

Description:

Resting control