Effect of Swimming on Premenstrual Syndrome
Primary Purpose
Premenstrual Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
About this trial
This is an interventional treatment trial for Premenstrual Syndrome
Eligibility Criteria
Inclusion Criteria:
- virgins.
- Their age ranged from 18 to 25 years old
- Their body mass index (BMI) ranged from 18 to 25 kg/m2.
- They were clinically and medically stable during the study
- Have regular menstrual cycle of 23 to 35 days duration
Exclusion Criteria:
- cardiopulmonary or orthopaedic problems
- women taking any hormonal drugs or drugs that affect hormones as antidepressnats during the preceding 3 months before participation in the study
- any abnormality in ovulation or those with pelvic inflammatory diseases (PID).
- Women with endocrine abnormality as thyroid, pituitary or ovarian disorders
Sites / Locations
- Kasr Alainy medical school
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Swimming group
Non swimming group
Arm Description
Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards. The exercise included three stages: warming up, swimming and cooling down.
no intervention
Outcomes
Primary Outcome Measures
Premenstrual distress questionnaire
47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03264612
Brief Title
Effect of Swimming on Premenstrual Syndrome
Official Title
Effect of Aeropbic Exercise as Swimming on Premenstrual Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 3, 2016 (Actual)
Primary Completion Date
May 14, 2017 (Actual)
Study Completion Date
August 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
Detailed Description
Each female sets her experience of 47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise) Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down. Warming up phase involved 5 minutes of breathing, circulatory and stretching exercises. Breathing diaphragmatic and costal exercise was performed. Diaphragmatic breathing exercise was performed at a convenient position with full relaxation, then she inspires deeply through the nose, ballooning her abdomen then expires through the mouth with a sigh and slowly and that was repeated 3-5 times.
Costal breathing exercise was done also at the woman favorable position then she inspires deeply through the nose, opens out her ribs then expires through the mouth with a sigh and slowly and that was repeated 3-5 times..
Circulatory foot and ankle exercises were done by instructing the woman to point her toes up and down, doing isometric calf muscle contractions and knee flexion and extension.
Stretching exercise of neck flexors, extensors, latissimus dorsi, Deltoid dorsal fibers, triceps, pectoralis major, supraspinatus, wrist , lumbar extensors, abdominal, lumbar flexors, lumbar rotators, hamstrings, adductor, gluteal, gastrocnemius, hip flexors, tensor fascia latae and quadriceps muscles were performed during warming up phase.
The second phase of treatment was swimming for 20 minutes starting with 5 minutes walking inside the pool around its edges, then forth and back swimming without reaching fatigue level for 15 minutes.
The last phase was cooling down phase which was the same exercises of the warming up phase for 5 minutes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Swimming group
Arm Type
Active Comparator
Arm Description
Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
Arm Title
Non swimming group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Other Intervention Name(s)
Swimming
Intervention Description
Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
The exercise included three stages: warming up, swimming and cooling down.
Primary Outcome Measure Information:
Title
Premenstrual distress questionnaire
Description
47 manifestations on a 6 point scale separately for the premenstrual, menstrual and intermenstrual phases of her latest and worst menstrual cycle. Daily Symptoms Report was filled at the start and at end of the study (before and after performing swimming exercise)
Time Frame
3 months after start of swimming
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
virgins.
Their age ranged from 18 to 25 years old
Their body mass index (BMI) ranged from 18 to 25 kg/m2.
They were clinically and medically stable during the study
Have regular menstrual cycle of 23 to 35 days duration
Exclusion Criteria:
cardiopulmonary or orthopaedic problems
women taking any hormonal drugs or drugs that affect hormones as antidepressnats during the preceding 3 months before participation in the study
any abnormality in ovulation or those with pelvic inflammatory diseases (PID).
Women with endocrine abnormality as thyroid, pituitary or ovarian disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29350276
Citation
Maged AM, Abbassy AH, Sakr HRS, Elsawah H, Wagih H, Ogila AI, Kotb A. Effect of swimming exercise on premenstrual syndrome. Arch Gynecol Obstet. 2018 Apr;297(4):951-959. doi: 10.1007/s00404-018-4664-1. Epub 2018 Jan 19.
Results Reference
derived
Learn more about this trial
Effect of Swimming on Premenstrual Syndrome
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