NCT05651568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

December 7, 2022

Last Update Submit

June 14, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

  • Body Mass Index

    Body mass index is a screening tool derived from the weight and height of a person. It is a simple numeric measure of a subject"s thickness or thinness. Calculated values help in determining if a person is underweight, normal weight or overweight. Body mass index used to classify average sedentary (physically inactive) populations, with an average body composition. Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in meters squared. A BMI of 25.0 or more is overweight, while the healthy range is 18.5 to 24.9.

    8th week

  • WHO quality of life Bref

    The WHOQOL- BREF is a 26 items self-report questionnaire consisting of 4 domains of quality of life. Physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains 2 items of overall QOL and general health.

    8th week

Study Arms (2)

Periodized resistance training

EXPERIMENTAL

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.

Other: Periodized resistance training

High intensity interval training

EXPERIMENTAL

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

Other: High intensity interval training

Interventions

Periodized resistance trainingOTHER

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.

Periodized resistance training
High intensity interval trainingOTHER

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).

High intensity interval training

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSRD

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 28546817BACKGROUND

  • 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. Erratum In: PLoS Med. 2022 Sep 2;19(9):e1004095. doi: 10.1371/journal.pmed.1004095.

    PMID: 35104295BACKGROUND

  • 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.

    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.

    PMID: 31390818BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Adeela Arif, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 15, 2022

Study Start

January 25, 2022

Primary Completion

January 25, 2023

Study Completion

March 15, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)