Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

This group will perform structured aerobics exercise program in addition to the standard treatment given for women with PCOS.

This group will receive the standard management given for women with PCOS

A 12 week structured aerobics exercise program will be offered. The patient has to perform exercise five times a week , 30 minutes a day

Structured aerobics exercise

Muhammad Irfan, FCPS,MS,PhD

Mifrah R Sethi, MSc, Mphil

Rukhsana Karim, MBBS,FCPS

Mahjabina S Ghayur, MBBS, FCPS

Sumaira Inayat, MBBS,FCPS

Samdana Wahab, MBBS,FCPS

Rabia Kareem, MBBS,FCPS

Polycystic ovary is one of the most common metabolic and endocrine disorders in women of reproductive age group. The Rotterdam criteria are used internationally for its diagnosis. It has been reported that 57% of these women have at least one mental disorder. There is no health without mental health and it is fundamental to the good health and well-being of an individual. Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall low quality of life. In the healthy population, exercise plays a pivotal role in the optimization of mental health, but there is little evidence available to demonstrate its effects on women with PCOS. So, this study has been designed to study the effects of structured aerobics exercise programs on the mental and physical health of women with PCOS.

Polycystic ovary syndrome is also referred to as "Hyperandrogenic anovulation or Stein Levinthal Syndrome". It has affected approximately 10 % of women of childbearing age. The prevalence of PCOS is higher among Pakistani women i.e. 52% as compared to the UK. The Rotterdam criteria are internationally used for the diagnosis of PCOS, which requires two out of the three features: signs of hyperandrogenism, ovulatory dysfunction, and ultrasound features of PCOS.

Although physical symptoms are increasingly recognized in women with PCOS, little attention has been paid to the mental health and well-being of these patients. PCOS creates an important psychological burden throughout the lifetime of these women. 57% of women with polycystic ovary syndrome have at least one mental disorder. Also, mental health is an essential part of public health and it is one of the most important indicators of the quality of health care in society.

Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall a lowered quality of life. In a healthy population, lifestyle modifications, particularly physical activity, and exercise play a pivotal role in the optimization of mental health but there is little evidence available to demonstrate the effects of exercise on the optimization of psychological well-being and physical health of women with PCOS. So, this study has been designed to study the effect of a structured aerobics exercise program on the mental and physical health of women with PCOS.

Effect of Aerobics on Physical and Mental Health in Polycystic Ovary Syndrome

The Effect of Structured Aerobics Exercise Programme for the Improvement of Mental and Physical Health Parameters in Patients With Polycystic Ovary Syndrome: A Randomised Controlled Trial

Change in the score of the PCO quality of life scale from baseline to midway to end of therapy, higher scores mean a better quality of life.

Change in the score of the Hospital anxiety and depression scale from baseline to midway to end of therapy, 0-7 indicates normal, 8 to 10 indicates borderline and 11-21 indicates abnormal cases. Higher scores mean a worse outcome

Change in the score of the ENRICH marital satisfaction scale from baseline to midway to end of therapy, higher scores mean better marital satisfaction.

Muhammad Irfan

Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Participants will receive Virtual Reality assisted Physical Therapy sessions (VRPT) in the first Physical Therapy (PT) session and will receive traditional Physical Therapy sessions (standard care) in the second Physical Therapy session under the supervision of the accredited physical therapist.

Participants will receive traditional Physical Therapy (PT) sessions (standard care) in the first Physical Therapy session and receive Virtual Reality assisted Physical Therapy sessions (VRPT) in the second Physical Therapy session under the supervision of the accredited physical therapist.

Participants are allowed to freely choose one game from the game list. Participant will be asked to wear a validated activity tracker - ActiGraph. Baseline heart rate will be collected for 1 minute. Participants will be wearing the ActiGraph during Physical Therapy session. Participants receiving VR intervention will be instructed to wear an Oculus Quest 2 headset (Meta, Inc., Menlo Park, CA) and participate in VR applications under the supervision of the physical therapist.

Virtual Reality Physical Therapy

Participants will receive traditional Physical Therapy sessions (standard care) under the supervision of the accredited physical therapist. Participants will be wearing the Actigraph during Physical Therapy session. Participants will perform regular physical exercise, such as 20 minutes walking or biking on a stationary bike, under the supervision of a physical therapist.

Traditional Physical Therapy

Thomas J Caruso

Man Yee MY Suen

This is an experimental study to evaluate the efficacy of a Virtual Reality aid Physical Therapy (VRPT) in increasing the physical activity levels and quality of life of children.

iMOVE: VRPT VS Traditional PT

Immersive Virtual Reality for Enhancement of Physical Activity in Pediatric Oncology : a Randomized Control Study (iMOVE)

Compare the total Metabolic Equivalent of Task (METs) rate of pediatric oncology patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch

Compare the total movement of pediatric oncology patients when undergo virtual reality assisted physical therapy and traditional physical therapy measured by ActiGraph watch

Patients will self-report fatigue according to the Adult OMNI-Walk/Run RPE Scale (OMNI RPE) scale after both the VR and standard of care portion. The OMNI RPE is an 11-categories perceived exertion rating scale with a numerical rating from 0 to 10 (0= Not Tired at All, 10= Very, Very Tired).

Measured by comparison Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) of patient in first physical therapy session and second physical therapy session .

Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (peds FACIT-F) is a 13 items -questionnaire which measures the fatigue scale of the patient with minimum score at 0 (low fatigue score) and maximum score at 52 (high fatigue score).

The modified WHO (Five) Well-Being Index is a participant-reported outcome measure that assesses current mental well being. Questionnaire contains 5 questions . Scores range from 0 to 5, with higher scores indicating the corresponding feeling exists all the time

Measured by comparison PROMIS Pediatric Item Bank GenPop v3.0 - Fatigue - Short Form 10a of patient in first physical therapy session and second physical therapy session .

PROMIS Pediatric Item Bank GenPop v3.0 - Fatigue - Short Form 10a is a 10 items -questionnaire which measures the fatigue scale of the patient with scores range from 1 to 5,(1 = never and 5 = Almost always).

Stanford University

Clinical Professor

Eye Diseases

Diseases and Abnormalities at or Before Birth

Behaviors and Mental Disorders

Rare Diseases

Retinoblastoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Quality of Life

Neuroepithelioma

MSK will contact all families of 1-year survivors of unilateral retinoblastoma treated with enucleation or intra-arterial chemotherapy at MSK and TCH between 2006 or later for completion of validated questionnaires integrating the BASC-3 and PROMIS surveys. The survey may be administered in-person during clinic or by mail, based upon participant preference.

A comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older.

BASC-3 survey

PROMIS survey

Laura Cimini, PhD

The purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). By quality of life, the investigators mean how the participants are feeling about being satisfied with things in their life, including, physical health, emotional health, and their ability to carry out daily activities. The investigators want to see if either treatment option would affect quality of life differently. The investigators hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.

Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma

as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3;as measured by the BASC-3) Surveys have been normed on a representative sample that closely matches United States census population characteristics; T scores and percentiles in relation to general norms are calculated for each scale. The BASC-3 uses a T score metric where 50 is the mean for the population norm and the standard deviation is 10.

as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3; The following four T Scores will be analyzed for these BASC-3 summary scores (1) Externalizing Problems, (2) Internalizing Problems, (3) Behavior Symptoms Index and (4) Adaptive Skills. The "at-risk" category applies to any individual who scores 2 SD above the mean of 50, while "clinically significant" risk refers to those who score 3 SD above the mean. Additional scores are also provided which may be used to identify risk for more specific behavioral or emotional areas of concern.

as measured by the Patient Reported Outcomes Measurement Information System (PROMIS®) PROMIS measures use a T-score metric where 50 is the mean for the reference population and 10 is the standard deviation of that population. Higher scores correspond to a higher degree of symptom burden (for those items measuring symptoms) or a higher level of functioning (for physical functioning items)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Aerobics on Physical and Mental Health in Polycystic Ovary Syndrome	NCT05577949	Polycystic Ovar...	Structured aero...	18 Years - 49 Years	Peshawar Medical College
iMOVE: VRPT VS Traditional PT	NCT05876156	Physical Health	Virtual Reality... Traditional Phy...	7 Years - 25 Years	Stanford University
Effect of Aerobics on Physical and Mental Health in Polycystic Ovary Syndrome	NCT05577949	Polycystic Ovar...	Structured aero...	18 Years - 49 Years	Peshawar Medical College
Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma	NCT03662776	Survivors of Un...	BASC-3 survey PROMIS survey	8 Years - 17 Years	Memorial Sloan Kettering Cancer Center

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