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Trial registered on ANZCTR


Registration number
ACTRN12613001195741
Ethics application status
Not yet submitted
Date submitted
25/10/2013
Date registered
30/10/2013
Date last updated
30/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an exercise intervention on menstrual pain in women with primary dysmenorrhea: A randomized controlled trial
Scientific title
Effects of vigorous aerobic training combined with an exercise programme in comparison to usual care on menstrual pain in women with primary dysmenorrhea: A randomized controlled trial.
Secondary ID [1] 283451 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Dysmenorrhea 290371 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290760 290760 0 0
Physiotherapy
Reproductive Health and Childbirth 290762 290762 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo vigorous aerobic training on a treadmill for 30 minutes at 70-85% of their maximum heart rate. Treadmill training will be preceded by warm-up exercises for 10 minutes and followed by cool down exercises for 10 minutes, including stretching for mid and lower back muscles and abdominal strengthening. The training sessions will be administered and supervised by a trained physiotherapist on a one-on-one participant basis at School of Physiotherapy (SoP), University of Otago. Frequency of intervention will be for 3 days a week for three weeks for a maximum of 50 minutes each session. On completion of intervention at SoP, participants will be required to continue at home, the walking/jogging program for 30 minutes, and warm up and cool down stretching and strengthening exercises for 10 minutes each, three times a week, in 3 week blocks between menstrual periods for the next 6 months. Attendance will be taken at every session at SoP, in order to monitor adherence to intervention programme. Adherence to home exercise programme will be monitored with the use of exercise adherence diary.
Intervention code [1] 288167 0
Lifestyle
Intervention code [2] 288183 0
Treatment: Other
Comparator / control treatment
Usual control group. No standard treatments are withheld and they are free to take medications for controlling their menstrual pain.
Control group
Active

Outcomes
Primary outcome [1] 290757 0
short form of McGill pain questionnaire
Timepoint [1] 290757 0
On day of maximum pain of menstual period pre-intervention; on day of maximum pain of menstrual period post-intervention; and on day of maximum pain of menstrual period at the end of 3 and 6 month follow up.
Secondary outcome [1] 305182 0
Patient Global Impression of Change
Timepoint [1] 305182 0
On day of maximum pain of menstual period pre-intervention; on day of maximum pain of menstrual period post-intervention; and on day of maximum pain of menstrual period at the end of 3 and 6 month follow up.
Secondary outcome [2] 305183 0
12-Item short form health survey
Timepoint [2] 305183 0
On day of maximum pain of menstual period pre-intervention; on day of maximum pain of menstrual period post-intervention; and on day of maximum pain of menstrual period at the end of 3 and 6 month follow up.
Secondary outcome [3] 305184 0
Women’s Health Initiative Insomnia Rating Scale
Timepoint [3] 305184 0
On day of maximum pain of menstual period pre-intervention; on day of maximum pain of menstrual period post-intervention; and on day of maximum pain of menstrual period at the end of 3 and 6 month follow up.
Secondary outcome [4] 305185 0
Brief pain inventory short form
Timepoint [4] 305185 0
On day of maximum pain of menstual period pre-intervention; on day of maximum pain of menstrual period post-intervention; and on day of maximum pain of menstrual period at the end of 3 and 6 month follow up.

Eligibility
Key inclusion criteria
Non-pregnant women 18-43 years with general good health with primary dysmenorrhea (PD); not on formal exercise programme; women with regular menstrual cycles and having no pelvic abnormality; PD with pain scoring greater than or equal to 4 on a 0-10 numeric rating scale (NRS) for at least two consecutive months.
Minimum age
18 Years
Maximum age
43 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with secondary dysmenorrhea; women having intra uterine devices; women on oral contraceptives and hormonal therapy and; women with menstrual cycle interval exceeding 34 days.

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


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 5537 0
New Zealand
State/province [1] 5537 0
Dunedin

Funding & Sponsors
Funding source category [1] 288164 0
Charities/Societies/Foundations
Name [1] 288164 0
Physiotherapy New Zealand
Country [1] 288164 0
New Zealand
Funding source category [2] 288165 0
Hospital
Name [2] 288165 0
Dunedin School of Medicine, Dunedin Hospital
Country [2] 288165 0
New Zealand
Funding source category [3] 288166 0
University
Name [3] 288166 0
School of Physiotherapy, University of Otago
Country [3] 288166 0
New Zealand
Primary sponsor type
Individual
Name
Catherine Chapple
Address
School of Physiotherapy,
Centre for Health, Activity, and Rehabilitation Research, University of Otago,
P.O Box 56,
Dunedin 9054,
Country
New Zealand
Secondary sponsor category [1] 286887 0
None
Name [1] 286887 0
Address [1] 286887 0
Country [1] 286887 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290080 0
Health and Disability Ethics Committee
Ethics committee address [1] 290080 0
Ministry of Health,
No 1, The Terrace,
PO Box 5013,
Wellington 6145.
Ethics committee country [1] 290080 0
New Zealand
Date submitted for ethics approval [1] 290080 0
29/11/2013
Approval date [1] 290080 0
Ethics approval number [1] 290080 0

Summary
Brief summary
Dysmenorrhea is the most common gynecological disorder experienced by menstruating women. Dysmenorrhea in the absence of pelvic abnormality is termed primary dysmenorrhea (PD). The health burden, social and economic cost of PD is high as it is reported to be the leading cause of recurrent absenteeism from school or work in adolescent girls and young adults. The efficacy of physiotherapy and complementary therapies such as acupuncture, acupressure, transcutaneous electrical stimulation, spinal manipulation, and heat therapy for PD have been extensively evaluated in experimental studies but the efficacy of exercise is poorly understood. The belief that exercise works for relieving symptoms in women with PD is based on anecdotal evidence and non-experimental studies. Moreover, there is very limited evidence high quality evidence to support the use of exercise to reduce the intensity and severity of menstrual pain/cramps. This clinical trial will therefore evaluate the effectiveness of exercise to reduce intensity and severity of pain in women with PD.
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 43846 0
Mrs PRIYA KANNAN
Address 43846 0
Postgraduate Student,
School of Physiotherapy,
University of Otago,
325 Great Kings street,
Dunedin 9054
New Zealand.
Country 43846 0
New Zealand
Phone 43846 0
+64 3 479 9619
Fax 43846 0
Email 43846 0
[email protected]
Contact person for public queries
Name 43847 0
Dawn Miller
Address 43847 0
Section of Obstetrics & Gynaecology,
Department of Women’s & Children’s Health
Dunedin School of Medicine,
Dunedin Hospital,
PO Box 913,
Dunedin 9054.
Country 43847 0
New Zealand
Phone 43847 0
+64 3 4747 999 ext 8566
Fax 43847 0
Email 43847 0
[email protected]
Contact person for scientific queries
Name 43848 0
Cathy Chapple
Address 43848 0
School of Physiotherapy,
University of Otago,
PO Box 56,
Dunedin 9054.
Country 43848 0
New Zealand
Phone 43848 0
+64 3 479 5428
Fax 43848 0
Email 43848 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

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