Trial Outcomes & Findings for High-Intensity Interval Training On Women With Polycystic Ovary Syndrome. (NCT NCT04942366)

NCT ID: NCT04942366

Last Updated: 2024-02-02

Results Overview

Levels of serum testosterone

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 0 weeks to 12-weeks
• Results posted on: 2024-02-02

Participant Flow

Serum testosterone was more than normal. Pre-diagnosed PCOS. Overweight or/and obese. Physical activity level (IPAQ).

Participant milestones

Measure	HIIT Group High intensity interval training will be performed thrice a week using a treadmill. High intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).	ST Group Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum). Strength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
Overall Study STARTED	25	25
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Measure	HIIT Group High intensity interval training will be performed thrice a week using a treadmill. High intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).	ST Group Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum). Strength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
Overall Study Withdrawal by Subject	5	5

Baseline Characteristics

10 participants withdrew from the study, five from each group and this is the reason why at the end of the study 40 participants were analyzed.

Baseline characteristics by cohort

Measure	HIIT Group n=20 Participants High intensity interval training will be performed thrice a week using a treadmill. High intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).	ST Group n=20 Participants Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum). Strength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.	Total n=40 Participants Total of all reporting groups
Age, Continuous	28.1 years STANDARD_DEVIATION 4.92 • n=20 Participants	30.5 years STANDARD_DEVIATION 4.80 • n=20 Participants	29.3 years STANDARD_DEVIATION 4.86 • n=40 Participants
Sex/Gender, Customized Females	20 participants n=20 Participants • 10 participants withdrew from the study, five from each group and this is the reason why at the end of the study 40 participants were analyzed.	20 participants n=20 Participants • 10 participants withdrew from the study, five from each group and this is the reason why at the end of the study 40 participants were analyzed.	40 participants n=40 Participants • 10 participants withdrew from the study, five from each group and this is the reason why at the end of the study 40 participants were analyzed.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Serum Testosterone	2.54 nmol/L STANDARD_DEVIATION 0.07 • n=20 Participants • Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analyzed.	2.54 nmol/L STANDARD_DEVIATION 0.09 • n=20 Participants • Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analyzed.	2.54 nmol/L STANDARD_DEVIATION 0.08 • n=40 Participants • Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analyzed.
Body fat percentage	31.6 percentage STANDARD_DEVIATION 1.79 • n=20 Participants • Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analysed.	34.1 percentage STANDARD_DEVIATION 2.70 • n=20 Participants • Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analysed.	32.9 percentage STANDARD_DEVIATION 2.60 • n=40 Participants • Five participants withdrew from the study, this is the reason why at the end of the study 20 participants were analysed.

PRIMARY outcome

Timeframe: 0 weeks to 12-weeks

Levels of serum testosterone

Outcome measures

Measure	HIIT Group n=20 Participants High intensity interval training will be performed thrice a week using a treadmill. High intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).	ST Group n=20 Participants Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum). Strength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
Serum Testosterone 0-week	2.54 nmol/L Standard Error 0.07	2.54 nmol/L Standard Error 0.09
Serum Testosterone 12-weeks	2.39 nmol/L Standard Error 0.14	2.47 nmol/L Standard Error 0.09

PRIMARY outcome

Timeframe: 0-week to 12-weeks

Using skinfold method (body caliper)

Outcome measures

Measure	HIIT Group n=20 Participants High intensity interval training will be performed thrice a week using a treadmill. High intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).	ST Group n=20 Participants Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum). Strength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
Body Fat Percentage 0-week	31.59 Percentage Standard Deviation 1.79	34.12 Percentage Standard Deviation 2.69
Body Fat Percentage 12-weeks	29.62 Percentage Standard Deviation 1.76	32.48 Percentage Standard Deviation 2.87

PRIMARY outcome

Timeframe: 0-week to 12-weeks

International physical activity questionnaire

Outcome measures

Measure	HIIT Group n=20 Participants High intensity interval training will be performed thrice a week using a treadmill. High intensity interval training: HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).	ST Group n=20 Participants Strength training will be performed thrice a week, each session will consist of eight dynamic drills (with resistance of 60 - 70 % of 1 repetition maximum). Strength training: Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
Physical Activity 0-week	3491.15 MET-mins/week Standard Deviation 211.99	3439.60 MET-mins/week Standard Deviation 243.76
Physical Activity 12-weeks	3928.10 MET-mins/week Standard Deviation 220.04	3716.60 MET-mins/week Standard Deviation 234.45

Adverse Events

HIIT Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ST Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mubarra Rao

Ziauddin University

Phone: 03343088915

Email: mubarrar@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place