Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT06129708

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was conducted to determine the difference between impact of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea Primary	Other: Aquatic Exercise Other: Aerobic Exercise	N/A

Detailed Description

Dysmenorrhea manifests as painful menstrual flow it occurs in two forms primary and secondary. Primary and secondary dysmenorrhea is painful menstruation occur without any gynecological disease it was conducted that prevalence of dysmenorrhea 74.6% and it was significantly more frequent in students from rural residence (Shaimaa et al., 2018).

There is only one previous study investigate effect of aquatic exercise on primary dysmenorrhea (Rezvani et al., 2013). There are several previous studies investigate effect of aerobic ex , however non of the previous studies compared between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life of adolescent girls .Therefore this study was the first one which aimed to investigate the difference between effect of aerobic and aquatic exercise on primary dysmenorrhea and quality of life in adolescent girls.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Aquatic Exercise Versus Aerobic Exercise on Primary Dysmenorrhea and Quality of Life in Adolescent Females: A Randomized Controlled Trial

Actual Study Start Date :

Oct 1, 2022

Actual Primary Completion Date :

Oct 1, 2023

Actual Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group (A) Aquatic Exercise Group They participated in an aqua aerobic exercise program, 3 days per week, for 8 weeks	Other: Aquatic Exercise The aquatic exercises included 5 minutes of warming up in form of walking and running in water, 20 minutes of aerobic and strengthening exercises of pelvis, abdominal and thigh muscles (Double-leg Squat, lunge, knee flexion and extension, hip flexion and
Experimental: Group (B) Aerobic Exercise Group They participated in an aerobic exercise program on a treadmill, 3 days per week, for 8 weeks.	Other: Aerobic Exercise The exercise protocol consists of 5 minute warm up, 35 min aerobic exercise and 5 minute cool-down. Exercises high-intensity treadmill-based treatment for primary dysmenorrhea for three days a week ,The Borg Rating of Perceived Exertion (RPE) Scale from 6 ('no exertion at all') to 20 ('maximal exertion') was used to regulate the exercise intensity on the treadmill. Participants were encouraged to increase the speed of the treadmill until they perceived their RPE to be between 14 and 16. or at a perceived exertion of 11.0 (Borg scale) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of maximum heart rate (MHR) (16.0-18.0 Borg scale) for 30 minutes. At the end of the exercise session, women completed a 5-minute cool-down (11.0 Borg scale).

Arm

Intervention/Treatment

Experimental: Group (A) Aquatic Exercise Group

They participated in an aqua aerobic exercise program, 3 days per week, for 8 weeks

Other: Aquatic Exercise

The aquatic exercises included 5 minutes of warming up in form of walking and running in water, 20 minutes of aerobic and strengthening exercises of pelvis, abdominal and thigh muscles (Double-leg Squat, lunge, knee flexion and extension, hip flexion and

Experimental: Group (B) Aerobic Exercise Group

They participated in an aerobic exercise program on a treadmill, 3 days per week, for 8 weeks.

Other: Aerobic Exercise

The exercise protocol consists of 5 minute warm up, 35 min aerobic exercise and 5 minute cool-down. Exercises high-intensity treadmill-based treatment for primary dysmenorrhea for three days a week ,The Borg Rating of Perceived Exertion (RPE) Scale from 6 ('no exertion at all') to 20 ('maximal exertion') was used to regulate the exercise intensity on the treadmill. Participants were encouraged to increase the speed of the treadmill until they perceived their RPE to be between 14 and 16. or at a perceived exertion of 11.0 (Borg scale) for the first five minutes (warm-up period), followed by aerobic exercise at 70-85% of maximum heart rate (MHR) (16.0-18.0 Borg scale) for 30 minutes. At the end of the exercise session, women completed a 5-minute cool-down (11.0 Borg scale).

Outcome Measures

Primary Outcome Measures

Assessment of dysmenorrhea severity [12 weeks]
It was assessed for each participant in the two groups (A & B) before and after 12 weeks of treatment at the first day of menstruation, using WaLIDD scale, which has high sensitivity and high specificity.
Measurement of pain intensity [12 weeks]
It was measured for each participant in both groups (A & B) before and after 12 weeks of treatment at the first day of menstruation, using the Arabic version of numeric pain rating scale. The respondents were required to select a number (0-10 integers) that best reflected the intensity of her pain. In the numeric pain rating scale, 0 represented no pain, 1-3 indicated mild pain, 4-6 indicated moderate pain, while 7-10 indicated severe pain.
Assessment of pressure pain threshold (PPT) [12 weeks]
The PPT was measured for each participant in both groups (A & B) before and after 12 weeks of treatment at the first day of menstruation, using a pressure algometry.
Assessment of health related quality of life [12 weeks]
The health related quality of life of all participants in both groups (A & B) was evaluated before and after the end of treatment program, using the Arabic version of EQ-5D-3L questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 20 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Healthy, nonsmoking, virginal girls having moderate to severe primary dysmenorrhea (score on pain rating scale > 3).
Their ages ranged from 14 to 20 years
Their body mass index (BMI) ranged from 18 to 25 kg/m2.
They haven't practice any sports at least one year

Exclusion Criteria:

Any musculoskeletal disorder.
Cardio-respiratory disease.
Diabetes, hypertension, or anemia.
Adolescent girls who have utilized hormonal treatment in the six months prior to study commencement.
currently undergoing pharmacological therapy for menstrual pain management

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Sohier M. Elkosery, Prof., Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asmaa Yossry Abdelrahman Ahmed, Physical Therapist at Shubra General Hospital, PhD student at Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT06129708

Other Study ID Numbers:

P.T.REC/012/004770

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Asmaa Yossry Abdelrahman Ahmed, Physical Therapist at Shubra General Hospital, PhD student at Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Cairo University

Pressure Pain Threshold

Quality of Life

Additional relevant MeSH terms:

Dysmenorrhea

Study Results

No Results Posted as of Nov 13, 2023