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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06129708
Other study ID # P.T.REC/012/004770
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2023

Study information

Verified date November 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 14 Years to 20 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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).

Locations

Country Name City State
Egypt Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of dysmenorrhea severity 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. 12 weeks
Primary Measurement of pain intensity 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. 12 weeks
Primary Assessment of pressure pain threshold (PPT) 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. 12 weeks
Primary Assessment of health related quality of life 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. 12 weeks
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