Aerobic Training With and Without Resistance Training in Polycystic Ovarian Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of Aerobic Training With and Without Resistance Training on Waist to Hip Ratio, Quality of Life and Menstrual Dysfunction in Polycystic Ovarian Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06198348
• Other study ID #: S22C14G92023
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polycystic ovary syndrome (PCOS) characterized by a chronic disorder in ovulation along with hyperandrogenism has become one of the most common endocrine disorders in women of reproductive age with an estimated 5%-15% prevalence. It has the symptoms such as menstrual disorders, infertility, hyperandrogenism, obesity, hirsutism and acne. PCOS is linked to Psychological morbidities e.g. increased risk of stress, depression, low self-esteem, poor body image, and reduced health-related quality of life. Approximately 75% of people with PCOS have a fat accumulation in the central area of the body.

Description:

A Randomized controlled trial will be conducted to determine the effects of Aerobic training with and without resistance training on the waist to hip ratio, QoL and menstrual dysfunction in polycystic ovarian syndrome. A sample size of 22 PCOS women's will be taken, Data will be collected from Jinnah Hospital Lahore by using PCOSQ and SF-36 questionnaire. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups of equal members. One group undergoing aerobic with resistance exercise training i.e., the experimental group and other with aerobic exercise i.e., control group. The interventions will be provided for 30 mints for 3 days per week for 2 months. All participants in both groups will be evaluated before and after the treatment programs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 15, 2024
• Est. primary completion date: March 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age 18-40yrs
• Waist to hip ratio >87(20)
• Women who are diagnosed according to Rotterdam criteria e.g. oligo/anovulation, hyperandrogenism, and polycystic ovaries.(21)
• Female who physically able to performs exercise

Exclusion Criteria:

• Women who are smoking and using drugs for depression.
• Married women
• Women with other pathological conditions like diabetes and thyroid diseases.
• Females who are not able to perform resistant exercise

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Aerobic Exercise
Treatment Protocol to Group A It consists of patients who will receive aerobic exercise sessions 3 times per week for 8 weeks. Every session will be of 30 minutes. It will include warm up phase, active phase and cool down phase Warm-up phase: In which each participant will walk at 80 m/min at for 5 min. Active phase: Brisk walking or treadmill: In which each participant will perform brisk walking for 15 mints initially. After that gradually duration of brisk walking will increase.
• Aerobic Exercises with Resistance training
These groups will perform these exercises: Aerobic exercise +resistance exercises Exercise Session: 3 days per week Time of exercise session: 30-45 min After following protocol of aerobic exercise as mentioned above the subjects will perform resistance exercises. These Exercises will perform: Leg press (dual leg press): Leg press targets the Glutes "Quadriceps or quads .but they also work your "Hamstrings". Crunches: Crunches Target the abdominal muscles specifically rectus abdominis and obliques. Squats: Squats targets the adductor muscles of the hip, glutes and rectus abdominis muscle Leg Extension Total Exercise plan for 12 weeks: 1-2 weeks: Repitations: 10-15 times No of sets: 1 set Resistance: minimum 3-4 weeks: Repitations: 10-15 times No of sets: 2 set Resistance: moderate 5-6 weeks: Repitations: 15-16 times No of sets: 2 set Resistance: moderate 7-8 weeks: Repitations: 15-16 times No of sets: 2 set

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SF-36 Questionnaire	QoL was assessed by the validated Portuguese version of the self-reported MOS SF-36, which consists of eight subscales: (1) Physical Role Function, (2) Physical Functioning, (3) Bodily Pain, (4) General Health Perception, (5) Vitality, (6) Social Role Functioning, (7) Emotional Role functioning, and (8) Mental Health. A substantial body of research supports the reliability of the SF-36 measurements.validity of SF-36 Questionnaire is 0.90 Subscale scores range from 0 to 100, with a lower score indicating lower QoL for that subscale.	8 weeks
Primary	Self-administered PCOSQ	All the participants filled up the self-administered PCOSQ. PCOS Questionnaire has 26 items divided into 5 domains: emotions (8 items), body hair (5 items), weight (5 items), infertility (4 items), and menstrual problems (4 items). Each question is associated with a 7point scale in which 7 represents optimal function and 1 represents the poorest Function. PCOSQ dimensions were internally reliable with Cronbach's a scores ranging from 0.70 to 0.97.	8 weeks
Primary	Measuring Tape	Waist circumference (WC) was measured with the participant in the standing position, with arms at the side of the body, feet together, and with a relaxed abdomen. For WC, a horizontal measurement was obtained on the narrower part of the dorsum (above the navel and below the xiphoid process.; Hip circumference (HC) was measured using the same positioning, as the region with the largest circumference of the buttocks. Waist-to-hip ratio (WHR) was measured by dividing the WC value by the HC value	8 weeks