Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000073707
Ethics application status
Not yet submitted
Date submitted
17/01/2013
Date registered
21/01/2013
Date last updated
21/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of exercise on menstrual pain in women with primary dysmenorrhea: A feasibility study
Scientific title
Effect of aerobic training and pelvic stretching and abdominal strengthening exercises on menstrual pain in women with primary dysmenorrhea: A feasibility study
Secondary ID [1] 281791 0
Nil
Universal Trial Number (UTN)
U1111-1138-6155
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Dysmenorrhea 288115 0
Condition category
Condition code
Reproductive Health and Childbirth 288490 288490 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be made to do pelvic stretching, pelvic rocking and abdominal strengthening exercises for 15 minutes followed by aerobic training on treadmill at an intensity of 70-85% of their maximum heart rate for 30 minutes. Maximum heart rate will be calculated by subtracting the participants age from 220. The training protocol will include a 3 week exercise and treadmill training and the training sessions will be administered and supervised by a trained physiotherapist on a one-on-one participant basis. Frequency of intervention will be for 3 days a week for a maximum of 45 minutes each session.
Intervention code [1] 286335 0
Treatment: Other
Comparator / control treatment
No control group. A single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288647 0
Short form of the Mc Gill Pain Questionnaire (SF-MPQ)
Timepoint [1] 288647 0
At baseline, 1st menstrual cylce after completion of intervention and follow up measurement during second menstrual cycle
Secondary outcome [1] 300695 0
Visual Analog Scale for Pain (VASP)
Timepoint [1] 300695 0
At baseline, 1st menstrual cylce after completion of intervention and follow up measurement during second menstrual cycle

Eligibility
Key inclusion criteria
Inclusion criteria:
(a) Non-pregnant women with general good health in the age group of 18-45 years with primary dysmenorrhea.
(b) Women with regular menstrual cycles and having no pelvic abnormality.
(c) Primary dysmenorrhea with pain scoring >4 on the visual analog scale (VAS range 0-10).
(d) Not on oral contraceptives and having no secondary dysmenorrhea.
(e) Women agreeing to refrain from the use of analgesics or other therapies during the course of their participation in the study.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
(a) Women with pelvic abnormalities, chronic pelvic pain or with history of endometriosis.
(b) Women on hormonal therapy or oral contraceptive pills and having intra uterine devices.
(c) Women with menstrual cycle interval exceeding 30 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study is nonrandomised trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study is nonrandomised trial
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
A t-test for paired comparisons will be used to compare pre-test and post-test mean scores.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4799 0
New Zealand
State/province [1] 4799 0
Dunedin

Funding & Sponsors
Funding source category [1] 286573 0
University
Name [1] 286573 0
Women’s & Children’s Health research committee,
University of Otago
Country [1] 286573 0
New Zealand
Primary sponsor type
Government body
Name
Physiotherapy Board of New Zealand
Address
Level 8
108 The Terrace
Wellington 6011
New Zealand

PO Box:
PO Box 10 734
Wellington 6143
New Zealand
Country
New Zealand
Secondary sponsor category [1] 285357 0
University
Name [1] 285357 0
Department of Women’s & Children’s Health,
University of Otago
Address [1] 285357 0
Section of Obstetrics & Gynaecology, Section of Obstetrics & Gynaecology, Department of Women’s & Children’s Health, Dunedin School of Medicine, PO Box 913, Dunedin 9054, NZ
Country [1] 285357 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288644 0
Health and Disability Ethics Committee
Ethics committee address [1] 288644 0
Health and Disability Ethics Committee
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 288644 0
New Zealand
Date submitted for ethics approval [1] 288644 0
04/02/2013
Approval date [1] 288644 0
Ethics approval number [1] 288644 0

Summary
Brief summary
The main purpose of this study is to examine the feasibility, of a promising intervention (exercise) that never became a standard treatment but with widespread acceptance with the evidence being mainly anecdotal. This study has been designed to optimise the training, content, and delivery of exercises to participants with menstrual pain.
The specific objectives for this study are to:

1.To assess recruitment processes and study uptake to inform the feasibility of running a full study
2. To evaluate the retention rate of participants
3. To evaluate the study protocol
4. To determine the feasibility of the proposed outcome measures
5. To estimate the effect size of the intervention

The experimental hypothesis is that a treatment program consisting of aerobic training, strengthening and stretching exercises would be effective in reducing the menstrual pain and severity among women with Primary dysmenorrhea
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37114 0
Mrs Priya Kannan
Address 37114 0
Post Graduate Student,
School of Physiotherapy,
375, Great King street,
University of Otago,
Dunedin 9016.
Country 37114 0
New Zealand
Phone 37114 0
+64 3 479 5422
Fax 37114 0
Email 37114 0
[email protected]
Contact person for public queries
Name 37115 0
Dr Dawn Miller
Address 37115 0
Section of Obstetrics & Gynaecology, Department of Women’s & Children’s Health
Dunedin School of Medicine, PO Box 913, Dunedin 9054,
Country 37115 0
New Zealand
Phone 37115 0
+64 3 474 7951
Fax 37115 0
Email 37115 0
[email protected]
Contact person for scientific queries
Name 37116 0
Dr Cathy Chapple
Address 37116 0
School of Physiotherapy
375, Great King street,
University of Otago,
Dunedin 9016.
Country 37116 0
New Zealand
Phone 37116 0
+64 3 479 6821
Fax 37116 0
Email 37116 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVigorous exercises in the management of primary dysmenorrhea: a feasibility study.2015https://dx.doi.org/10.3109/09638288.2014.962108
N.B. These documents automatically identified may not have been verified by the study sponsor.