Effect of Periodized Resistance Training and High Intensity Training on BMI and QOL in PCOS

NCT ID: NCT05651568

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2023-03-15

Brief Summary

This study may help to improve strength and body composition in females with PCOS. It will enhance ability of an overweight individual to perform functional tasks (i.e. daily living tasks or physical activity) to be physically active. This may facilitate the adoption of a more active lifestyle, thereby increasing the likelihood of success in overall weight-reduction strategies.

Detailed Description

Poly cystic ovarian syndrome (PCOS) is a hormonal disorder which is most common in females with fertile age. A number of small fluid filled sacs formed in ovaries which results in failure of egg release. Poly cystic ovary syndrome (PCOS) is an endocrine problem which is characterized by the polycystic ovaries, menstrual problems, infertility, metabolic disorder, psychological problems, elevated androgens, hirsutism, acne and obesity. PCOS also causes psychological disorders which include depression, anxiety, poor body image, low self-esteem and decreased health- related quality of life. Some well-controlled randomized clinical studies have been conducted to evaluate the effects of exercise training program in women with PCOS. There are many beneficial effects of exercises which improve physical fitness, body composition, and cardiovascular, hormonal, reproductive and psychological outcomes. Periodization training program involves period of active rest which allows muscle adaptations through variable intensity, volume and rest. The advantage of periodization is that it prevent from overtraining symptoms such as muscle stiffness, muscle soreness, sprain, strain, possible injury and decreased performance. High intensity interval training is effective in reducing body mass index and improving body composition in females with PCOS.

The study will be a randomized clinical trial and will be conducted in Mohsin memorial hospital Faisalabad. This study will be completed in time duration of ten months after the approval of synopsis and convenient sampling technique will be used. Total twenty four subjects will be assigned randomly by using lottery method into two groups. Group A will receive periodized resistance training and Group B will receive high intensity interval training. Warm up and cool down period of ten minutes of treadmill training will be performed by both groups. Data will be collected from all participants at baseline and after 8 weeks of treatment by using BMI and WHO-QOL BREF questionnaire. After assessing the normality data will be analyzed by using parametric or non-parametric test by using SPSS-25.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Periodized resistance training

It consists of patients who will receive periodized resistance training 3 sessions per week for 8 weeks. Resistance training has been performed according to FITT principal and as per ACSM recommendation.

Group Type: EXPERIMENTAL

Periodized resistance training

Intervention Type: OTHER

It consists of patients who will receive periodized resistance training 3 sessions per week for 8 weeks. Resistance training has been performed according to FITT principal and as per ACSM recommendation.

Frequency:

Three days in a week

Intensity:

60% intensity with one repetition maximum and 10% intensity were added each the two weeks.4 sets and 8-12 rep as per ACSM criteria. There will be rest of 60 second after every set and 120 seconds after every exercise.

Type:

8 types of resistance exercises were performed. There were 4 set of each exercise with 8 to 12 repetitions. These exercises are smith press, seated press, squat, lying dumbbell leg curls, leg extension, leg press, standing barbell, lying barbell and sit ups.

Time:

40 minutes per session.

High intensity interval training

It consists of patients who will receive high intensity interval training 3 sessions per week for 8 weeks for 30-35 minutes.

Group Type: EXPERIMENTAL

High intensity interval training

Intervention Type: OTHER

It consists of patients who will receive high intensity interval training 3 sessions per week for 8 weeks for 30 to 35 minutes.

Active phase: Two weekly sessions of four times four minutes at 90-95% of individual heart rate maximum, separated by three minutes of active rest period and one weekly session of ten times one minute with maximal intensity, separated by one minute of active rest. The exercise mode will be treadmill or outdoor walking/running or cycling (self-selected).

Interventions

Periodized resistance training

It consists of patients who will receive periodized resistance training 3 sessions per week for 8 weeks. Resistance training has been performed according to FITT principal and as per ACSM recommendation.

Frequency:

Three days in a week

Intensity:

60% intensity with one repetition maximum and 10% intensity were added each the two weeks.4 sets and 8-12 rep as per ACSM criteria. There will be rest of 60 second after every set and 120 seconds after every exercise.

Type:

8 types of resistance exercises were performed. There were 4 set of each exercise with 8 to 12 repetitions. These exercises are smith press, seated press, squat, lying dumbbell leg curls, leg extension, leg press, standing barbell, lying barbell and sit ups.

Time:

40 minutes per session.

Intervention Type: OTHER

High intensity interval training

It consists of patients who will receive high intensity interval training 3 sessions per week for 8 weeks for 30 to 35 minutes.

Active phase: Two weekly sessions of four times four minutes at 90-95% of individual heart rate maximum, separated by three minutes of active rest period and one weekly session of ten times one minute with maximal intensity, separated by one minute of active rest. The exercise mode will be treadmill or outdoor walking/running or cycling (self-selected).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 20-35 years
• Unmarried females
• Diagnosed patients of PCOS
• All women who are less physically active or have sedentary life style.
• BMI>25kg/m2 (overweight obese)

Exclusion Criteria

• Use of hormonal contraceptives.
• Diabetes
• Hypertension
• Thyroid disease
• Cushing disease
• Any physical disability

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adeela Arif, Mphil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

PSRD

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

Christodoulopoulou V, Trakakis E, Pergialiotis V, Peppa M, Chrelias C, Kassanos D, Papantoniou N. Clinical and Biochemical Characteristics in PCOS Women With Menstrual Abnormalities. J Family Reprod Health. 2016 Dec;10(4):184-190.

Reference Type: BACKGROUND

PMID: 28546817 (View on PubMed)

Venkatesh SS, Ferreira T, Benonisdottir S, Rahmioglu N, Becker CM, Granne I, Zondervan KT, Holmes MV, Lindgren CM, Wittemans LBL. Obesity and risk of female reproductive conditions: A Mendelian randomisation study. PLoS Med. 2022 Feb 1;19(2):e1003679. doi: 10.1371/journal.pmed.1003679. eCollection 2022 Feb.

Reference Type: BACKGROUND

PMID: 35104295 (View on PubMed)

Jobanputra H, Pawar V, Guhe A, Kalambe SRNM, Chaudhary A. Polycystic Ovarian Syndrome with Physical Therapy Management and A Proof-Primarily Based Totally Evaluation Article for Exercise in Pcos. NVEO-NATURAL VOLATILES & ESSENTIAL OILS Journal| NVEO. 2021:1370-81.

Reference Type: BACKGROUND

Clemente-Suarez VJ, Ramos-Campo DJ. Effectiveness of Reverse vs. Traditional Linear Training Periodization in Triathlon. Int J Environ Res Public Health. 2019 Aug 6;16(15):2807. doi: 10.3390/ijerph16152807.

Reference Type: BACKGROUND

PMID: 31390818 (View on PubMed)

Other Identifiers

RiphahIU Adeela Arif

Identifier Type: -

Identifier Source: org_study_id