NCT06129708

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 8, 2023

Last Update Submit

November 8, 2023

Conditions

Keywords

Primary DysmenorrheaAdolescent FemalesAquatic ExerciseAerobic ExercisePressure Pain ThresholdQuality of Life

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Group (A) Aquatic Exercise Group

EXPERIMENTAL

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

Other: Aquatic Exercise

Group (B) Aerobic Exercise Group

EXPERIMENTAL

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

Other: Aerobic Exercise

Interventions

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

Group (A) Aquatic Exercise Group

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).

Group (B) Aerobic Exercise Group

Eligibility Criteria

Age14 Years - 20 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

Related Publications (1)

  • Abdelrahman AY, El-Kosery SM, Abbassy AH, Botla AM. Effect of aquatic exercise versus aerobic exercise on primary dysmenorrhea and quality of life in adolescent females: A randomized controlled trial. Physiother Res Int. 2024 Jul;29(3):e2095. doi: 10.1002/pri.2095.

MeSH Terms

Interventions

Aquatic TherapyExercise

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sohier M. Elkosery, Prof.

    Department of Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

    STUDY CHAIR

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
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist at Shubra General Hospital, PhD student at Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations