Comparative Effects of Pilates exercises versus Aerobic Training on Menstrual Pain, Balance and Daily Functioning in University Students with Primary Dysmenorrhea
To evaluate the effectiveness of Pilates exercises on Menstrual Pain, Balance and function in university students with Primary Dysmenorrhea.
Design
Parallel group randomized clinical trial and Randomization will be achieved through computer generated random number table.
Settings and conduct
Outpatient Physical Therapy Department of Safi Hospital, Faisalabad, Pakistan. It will be accessor blinded study Who will be unaware of the type of intervention patients have received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Students with Primary Dysmenorrhea, Age:18 to 25 years, having regular Menstrual cycles, Moderate-to-severe Primary Dysmenorrhea-associated pain, indicated by a score of ≥4 on a numerical rating scale, ranging from ‘0’ (no pain) to ‘10’ (unbearable pain) for at least two previous consecutive menstrual periods, The participants were not involved in other exercise programme
Exclusion Criteria:
Menstrual cycles> 35 days, Pregnant females, No pain relief with over the counter analgesic
Intervention groups
Group A: Intervention group 1: The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Pilates for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes.
Group B: Intervention Group 2: The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Aerobic training for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes.
Main outcome variables
Pain,
Balance,
Daily functioning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230216057434N6
Registration date:2023-04-05, 1402/01/16
Registration timing:registered_while_recruiting
Last update:2023-04-05, 1402/01/16
Update count:0
Registration date
2023-04-05, 1402/01/16
Registrant information
Name
Zainab Sheraz
Name of organization / entity
Riphah International University, Faisalabad
Country
Pakistan
Phone
+92 301 7070941
Email address
zainab.48@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2023-05-20, 1402/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects of Pilates exercises versus Aerobic Training on Menstrual Pain, Balance and Daily Functioning in University Students with Primary Dysmenorrhea
Public title
Pilates exercises in Primary Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Students with Primary Dysmenorrhea
Age group 18 to 25 years
Having regular Menstrual cycles
Moderate-to-severe Primary Dysmenorrhea-associated pain, indicated by a score of ≥4 on a numerical rating scale
Ranging from ‘0’ (no pain) to ‘10’ (unbearable pain) for at least two previous consecutive menstrual periods
Exclusion criteria:
Menstrual cycles > 35 days apart•
Pregnant females
No pain relief with over the counter analgesics
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through a computer software "Random allocation software Version 2. The total sample size will be entered with required number of participants to be allocated in two groups. An automated randomization list will be achieved with attrition rate included.
The program starts running with the default settings. Users may run the program with the default settings or set the number of groups, the name of participants in each group and the sample size. Clicking the 'Generate' button produces the random sequence. Before generating the random sequence, the option window will be displayed and different randomization settings can be entered.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will received
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah International University Faisalabad
Street address
Riphah International University, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2022-05-12, 1401/02/22
Ethics committee reference number
RCRAHS/REC/23/09
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
Assessment will be performed at 0 week (baseline) at 4t week and at completion of 8 weeks treatment
Method of measurement
McGill pain Questionnaire
Secondary outcomes
1
Description
Static Balance
Timepoint
Assessment will be performed at 0 week (baseline) at 4th week and at completion of 8 weeks treatment
Method of measurement
one leg standing test with eyes open and closed
2
Description
Dynamic balance
Timepoint
Assessment will be performed at 0 week (baseline) at 4th week and at completion of 8 weeks treatment
Method of measurement
Berge Balance Scale
3
Description
Daily Functioning
Timepoint
Assessment will be performed at 0 week (baseline) at 4th week and at completion of 8 weeks treatment
Method of measurement
Brief Pain Inventory - Short form
Intervention groups
1
Description
Intervention group 1 ( Pilates exercises): The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Pilates for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes.The session will be conducted three times per week, each session will be started with warm up exercise including simple stretching for 10 minutes preceded by pilates for 20 minutes, and followed by cool down exercises comprising of simple breathing for 10 minutes.Pilates exercises will be performed at basic level in the form of roll up(6 repetition), double leg stretch(5-10 repetition) and spine stretch foreward(5 repetition) for first two weeks, intermediate level with the single leg stretch(10 repetitions), saw(4 repitition) and criss cross(5-10 repetitions) for third to fifth week and advance level in the form of shoulder bridge(3 repetitions) for sixth to eighth week.
Category
Treatment - Other
2
Description
Intervention group 2 (Aerobic Training)The training will be started with warm-up exercises including simple stretching of whole body for 10 minutes preceded by Aerobic training for 20 minutes, and followed by cool-down exercises comprising of simple breathing for 10 minutes. The aerobic training session will be conducted three times per week each session will be started with warm up exercise including simple stretching for 10 minutes preceded by running on treadmill (B1 motorized treadmill 3.0 HP, black) for 20 minutes, and followed by cool down exercises comprising of simple breathing for 10 minutes .During the session the distance covered by the participants on the treadmill and the heart rate will be recorded via pedometer and radial pulse with 70-85% of their maximum heart rate (maximum heart rate= 206-88% of age in years) respectively
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Safi Hospital
Full name of responsible person
Mubashra Nouman
Street address
Safi Hospital, Near Fish Farm, Satyana Road , Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 320 5200051
Email
mubasharanouman@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self funded
Full name of responsible person
Zainab Sheraz
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
N/A
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University, Faisalabad
Full name of responsible person
Zainab Sheraz
Position
Senior Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6600141
Email
zainab.48@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Real Patient involved
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available