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NCT Number: NCT06303219

Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome

To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome

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Key information

Conditions

Polycystic Ovarian Syndrome Adnexal Diseases Anxiety Disorders Cysts Endocrine System Diseases Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Mental Disorders Neoplasms Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Polycystic Ovary Syndrome Signs and Symptoms Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gynecological Department of Fatima Memorial Hospital

Lahore, 05499, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with BMI greater than 25kg/m2
  • Oligo- or anovulation/irregular cycles i.e 35 days
  • Married women
  • Primary infertility
  • A diagnosis of polycystic ovaries based on ultrasound results

Exclusion criteria

  • Use of psychiatric or psychotropic medications.
  • Unresolved gynecological conditions i.e Cervical Dysplasia, Pelvic floor prolapse, Uterine Fibroids, Urinary Incontinence
  • Diabetes, pregnancy, smoking, illness or injury that prevented or limited exercise performance and existing participation in regular physical activity

Treatment and study plan

RADITIONAL MODERATE INTENSITY TRAINING

Other

It consists of patients who will receive High-intensity interval training, including running as well as walking at 80% to 95% HR peak. Which is monitored by a smart watch. Before starting treatment, it follows a 10-minute warm-up exercise which includes basic stretches (Quads, Hams, and calf muscles) with a 30-second hold of both legs and same exercise will be pursued for the cool-down period. This intervention will be performed 5 days per week for 4 weeks.

The total duration of this session will be 50 minutes

High Intensity Interval Training

Other

It consists of patients who will receive Moderate-intensity interval training, including running as well as walking at 60% HR peak. Which is monitored by a smart watch. Before starting treatment, it follows a 10-minute warm-up exercise which includes basic stretches (Quads, Hams, and calf muscles) with a 30-second hold of both legs and same exercise will be pursued for the cool-down period. This intervention will be performed 5 days per week for 4 weeks.

The total duration of this session will be 50 minutes (

Primary outcomes

  1. Hamilton Anxiety Rating scale (HAM-A)

    Time frame: 4th week

    The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Although the HAM-A remains widely used as an outcome measure in clinical trials. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Reliability and concurrent validity of the HAM-A and its subscales were sufficient. The Cronbach's α of the Hamilton Anxiety Scale was 0.89

  2. The Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ)

    Time frame: 4th week

    The PCOSQ consists of five domains, each relating to a common symptom of PCOS; body hair, emotions, infertility, menstrual problems and infertility. Each question on the PCOSQ is associated with a 7-point scale in which 7 represents optimal function and 1 the poorest function. All five PCOSQ dimensions were internally reliable with Cronbach's alpha scores ranging from 0.70 to 0.97. Intra-class correlation coefficients to evaluate test-retest reliability were high (range 0.89-0.95, P < 0.001). All five PCOSQ dimensions were internally reliable with Cronbach's α scores ranging from 0.70 to 0.97. Construct validity was demonstrated by high correlations for PCOSQ (0.49 and 0.54)

  3. The Fatigue Impact Scale (FIS)

    Time frame: 4th week

    The FIS was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Daily Fatigue Impact Scale (D-FIS) consist of eight items that could be used for monitoring daily changes in fatigue. The test-retest reliability of FIS was good in terms of its cognitive, physical, and psychosocial subscales and total scores, with ICC values of 0.78, 0.73, 0.80, and 0.83, respectively

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Traditional Moderate Intensity Training and High Intensity Interval Training on Anxiety, Fatigue and Quality of Life in Polycystic Ovarian Syndrome

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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