To Compare the effectiveness of aerobic and kegal exercises on menstruation related pain and fatigue in primary dysmenorrhea
Design
The design of this study is Randomized, parallel Clinical Trial. Randomization is done by lottery method. In this method, the researcher gives each participant of the trial a number. Researchers draw numbers from the box randomly to allocate participants in two groups.
Settings and conduct
This study is conducted at Rashid latif medical college.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• 18-25 years old, young female
• Bleeding time 3-10 days
• Primary dysmenorrhea [patient are previously diagnosed]
• Not taking any vitamin or mineral supplementation during one menstrual cycle before trial
• Not practicing physical exercise [ more than 3 times a week ,for >30 min ]
Exclusion Criteria
• chronic disease[ heart disease ,respiratory disease ,asthma, nervous disorder etc ]
• history of irregular cycles
• history of gynecological surgery
• women who use oral contraceptives
Intervention groups
Patient of group A received aeorbic exercise
Patient of group B received Kegel exercises
Main outcome variables
The intensity of pain is measured by the numeric pain rating scale which is an accurate and reliable tool for measuring pain intensity symptoms of primary dysmenorrhea.
Fatigue is assessed by an accurate and reliable scale i.e: fatigue severity scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220626055280N1
Registration date:2023-01-13, 1401/10/23
Registration timing:registered_while_recruiting
Last update:2023-01-13, 1401/10/23
Update count:0
Registration date
2023-01-13, 1401/10/23
Registrant information
Name
Nazeer Ahmad
Name of organization / entity
Rashid Latif medical college
Country
Pakistan
Phone
+92 333 8054247
Email address
nazeer.ahmad@rlmc.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-28, 1401/10/07
Expected recruitment end date
2023-05-28, 1402/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Aerobic and Kegel exercises on menstruation related pain and fatigue in females with primary dysmenorrhea
Public title
Effect of Aerobic and Kegel exercises on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-25 years old, young female
Menustral Bleeding time 3-10 days
Previously diagnosed with primary dysmenorrhea
Not practicing physical exercise for more than 3 times a week ,for more than 30 min
Exclusion criteria:
taking any vitamin or mineral supplementation during menstrual cycle
history of irregular cycles
history of gynecological surgery
women who use oral contraceptives
chronic disease e.g.: heart disease ,respiratory disease ,asthma, nervous disorder
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 45 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 38 cards were taken out, 19 participants in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding of patients means that the patients did not know which treatment group are they allocated. This blinding is achieved by concealment. The allocation sequence is concealed in envelopes which were numbered serially, and letter envelopes are opened only after all pre-intervention assessments of the participants have been completed. This is done to avoid biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of Rashid Latif Medical College
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Approval date
2022-10-05, 1401/07/13
Ethics committee reference number
IRB/2022/058
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Pain
Timepoint
Pre and 1 Month Post
Method of measurement
The intensity of pain is measured by the numeric pain rating scale which is an accurate and reliable tool for measuring pain intensity symptoms of primary dysmenorrhea.
2
Description
Fatigue
Timepoint
Pre and 1 Month Post
Method of measurement
Fatigue is assessed by an accurate and reliable fatigue severity scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patient of group A aerobic exercises: The protocols for exercise training in the study include, Frequency: 3 days per week for one menstrual cycle. Time: 20-30 minutes per session (5-10minutes warm-up, 15-20 minutes aerobics, 5 minutes cool-down)Type: Stationary cycling and treadmill Speed: 4-6 mph
Category
Prevention
2
Description
Intervention group: Patient of group B received Kegel exercises in form of pelvic floor exercises [ 10 min] , and warm up and cool down [both for 5 min].Pelvic Tilt Patient is in crook lying position. Ask them to lift the pelvis off the plinth with hands placed by the side. Hold this position for 10 seconds Repeat for 25 times. Kegel Exercise: Squeeze the pelvic muscle for 10 seconds and relax it for 10 seconds stop after 3 repetitions. Repeat this exercise three times in a day. Flutter Exercise: Squeeze the pelvic muscles and relax it as quickly as possible for 10 contractions. It is recommended 3times a day. Subtle Exercise: First exercise, except that with the imagination that the person is sucking and holding tampon in the vagina for 10 seconds and release the contraction. Relax for 10 seconds.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rashid Latif Medical College
Full name of responsible person
Maryam Sarfraz
Street address
25-Km Ferozepur road Lahore
City
Lahore
Postal code
54900
Phone
+92 333 4435278
Email
maryamsarfraz33@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Nazeer Ahmad
Street address
35-Km Ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 333 8054247
Email
nazeer.ahmed@rlmc.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical College
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Maryam Sarfraz
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4435278
Email
maryamsarfraz33@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Nazeer Ahmad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 8054247
Email
nazeer.ahmad@rlmc.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Nazeer Ahmad
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-Km Ferozepur road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 8054247
Email
nazeer.ahmad@rlmc.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available