Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02189356 |
| Other study ID # |
1491-348-11/1539-227 |
| Secondary ID |
GMMA |
| Status |
Completed |
| Phase |
N/A
|
| First received |
July 10, 2014 |
| Last updated |
July 12, 2014 |
| Start date |
September 2011 |
| Est. completion date |
June 2012 |
Study information
| Verified date |
July 2014 |
| Source |
Gulhane Military Medical Academy |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Turkey: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study was to evaluate the effect of exercise programs on pregnant women with
pregnancy-related Low Back and Pelvic Pain (LBPP). Hypotheses of the study were: 1) Exercise
programs relieve the intensity of LBPP in pregnant women and 2) Exercise programs promote
functional capacity for pregnant women with LBPP.
Description:
Design The study was a prospective randomized trial with a control group (standard care
group) and an intervention group, using a repeated measures design. Forty-eight pregnant
participants with pregnancy-related LBPP were included in the control group and 48 pregnant
participants with pregnancy-related LBPP were included in the intervention (exercise) group.
Participants This research was performed between December 2011 and May 2012 at the
Department of Obstetrics and Gynecology, Gulhane Military Medical Education and Research
Hospital in Ankara, Turkey. Approximately 3,000 births occur annually at this clinic.
Participants were pregnant women who presented to the obstetrics department for routine
pregnancy examinations, had pregnancy-related LBPP and fulfilled the eligibility criteria.
Eligibility criteria of the research were determined following a literature review. The
eligibility criteria were;
- Age over 18 years old
- Ability to read and write in Turkish,
- Volunteering to participate in the study,
- Being between 20-35 weeks of gestation,
- Having no complications for any reason during the study,
- No diagnosis of low back and/or pelvic disease prior to pregnancy,
- Not performing exercise for half an hour at least three days a week during pregnancy,
- Not using analgesics for low back and pelvis pain,
- Not using other methods for the treatment low back and pelvic pain,
- Giving birth before the completion of the study Interventions Participants diagnosed
with pregnancy-related LBPP by a doctor and with no medical obstacles to participation
in the study were directed to nurse. The nurse invited the pregnant women to the
research room for a discussion about low back and pelvic pain. After the eligibility
criteria of the pregnant women were reviewed, initial assessments were completed and
the participants were subsequently randomized.
The nurse gave health counseling to the participants in the intervention group about the
prevention of pregnancy-related LBPP and initiated an exercise program that included
exercise training. The health counseling and exercise training booklets provided were
prepared based on the literature. Each counseling session lasted an average of 45 minutes.
Sessions were completed in a positive education atmosphere and were face-to-face as
consistent with the principles of adult education. The structure and function of the
vertebrae, physical changes occurring during pregnancy, causes of pregnancy-related LBPP,
the problems that the pain causes, methods of pain management, correct posture development,
body mechanics during activities of daily life and ergonomics were explained to the pregnant
women using illustrated booklets given during the trainings. During the counseling, the
nurse received information from the participants regarding their daily activities and
educated the participants about the behaviors that might damage the low back and pelvic
regions. Participants were given practical demonstrations of how to move and how to protect
the low back and pelvic regions during daily life. For example, the nurse demonstrated how
to retrieve an object from the ground, how to reach shelves, how to sit and stand up and how
to lie down, guiding the participants through these activities as well. The participants'
questions were answered, and they were given educational booklets. Following the health
consultation, exercise education was given. The participants were given illustrated booklets
explaining the effects of pregnancy exercises on maternal and fetal health, situations that
need attention before starting and during exercises, signs of danger, what should be done in
potentially dangerous situations, how to breathe during exercise and the method, frequency
and amount of the exercise. The exercises given to the intervention group were based on the
guidelines from "Exercise in Pregnancy" by the Royal College of Obstetricians and
Gynaecologists (RCOG) and the guidelines from "Pregnancy and Exercise" by Hacettepe
University in Turkey. It was emphasized that pregnant women should complete their exercises
as shown at least three days a week for 30 minutes. The duration of the exercise program was
four weeks. Participants were offered a choice of two types of exercise according to the
weather conditions. The first option comprised exercises performed on a mattress, including
stretching, tightening and loosening movements that targeted large muscle groups from the
neck to the vertebrae. The nurse explained that the mattress exercises would start with a 5
minute warm up, continue for at least 15-20 minutes at mid-tempo and end with a 5 minute
cool down. The second option was a walking exercise. The participants were expected to warm
up for 5 minutes, increase their speed for 5 minutes, continue at mid-tempo for 15 minutes
and complete a 5 minute cool down. It was emphasized that the pulse rate should be between
120-160/min when the participants reached mid-tempo. In this exercise program, we assumed
that both the walking exercise and the mattress exercises had equal effects on the low back
and pelvic pain. Pregnant women were able to choose the type of exercise according to their
wishes and requirements and could use either or both of the exercise options. The nurse
determined the exercise plan with the pregnant women, creating an individual exercise
program according to the patient's personal characteristics. The participants were asked to
record the type and the duration of the completed exercises during the program on the data
collection form and were asked to note if they encountered any problems during the program.
The nurse taught the participants how to fill out the forms and answered any questions about
the programs. The nurse spoke with the pregnant women on the phone three times a week and
gave counseling according to their needs. During interviews, pregnant women were reminded to
complete the data collection forms. After four weeks, the researchers made a final
assessment of the pregnant women and collected the forms during a face-to-face interview.
The exercise programs were terminated at this point, though the pregnant women were able to
continue the counseling if they wished.
The pregnant women in the control group received usual care, comprised of routine clinical
practice for pregnancy-related LBPP. The control group participants were recommended bed
rest and analgesics for LBPP and were not given any treatment for LBPP in addition to
standard care. Pregnant women in the control group did not exercise before the study or
during the study. The nurse spoke with the women in the control group on the phone once a
week and asked them to assess their LBPP and complete the data collection form. The final
assessments of the participants were made during a face-to-face interview four weeks later.
Willing pregnant women in the control group were advised on pain management strategies after
completion of the four weeks of the study.
Sample size and statistical power considerations The sample size was calculated using the PS
Software: Power and Sample Size program. Using the literature, we calculated that a sample
size of 48 pregnant women in both the exercise group and the control group (total 96
pregnant women) could allow for detection of a difference in VAS score of 10 mm between the
intervention and control group, given a SD of 15 mm with accompanying 0.95% confidence
intervals (CI) and a power of 0.90.
Randomization According to the CONSORT requirements, the participants were randomly
allocated to either the intervention group (n=48) or the control group (n=48) using opaque,
sealed envelopes and a simple randomization method. The nurse at the clinic randomly drew
the envelopes and broke the seal in the nursing room. The nurse explained the study's
purpose and procedures to the pregnant women in the control and intervention groups. The
same procedure was repeated for all the pregnant women. Blinding of participants was not
feasible due to the study design.
Primary outcomes The primary outcomes of this study were the change in pain intensity at the
end of four weeks compared with the baseline and the changes in functional status at the end
of weeks first and fourth.
Data collection The nurse collected the data by meeting with the pregnant women at the
beginning and end of the study for a total of two interviews. The data collection form
included the sociodemographic characteristics of the pregnant women, their pregnancy
history, and questions regarding any history of pain. In these meetings the nurse measured
the severity of the LBPP and determined the functional status of the pregnant women. The
participants measured the severity of LBPP at the end of each week for a total of 4
measurements and recorded their pain on a "Weekly Pain Follow-up Form". Additionally,
participants in the intervention group recorded their exercises on a "Daily Exercise Form".
The forms were collected for evaluation by the nurse at the completion of the study.
Measures Pain Intensity We used the Visual Analogue Scale (VAS) to measure the intensity of
the participants' pain. The VAS is a reliable and valid scale that widely used all over the
world for the assessment of pain intensity. Pregnant women noted the severity of the low
back and pelvic pain that they perceived on a 100 mm VAS. The nurse determined the intensity
of pain by measuring the point the pregnant woman had marked with a ruler. We examined the
intensity of two types of pain; perceived pain intensity at rest as VASrelaxation and
perceived pain intensity during activity as VASactivity.
Functional Level The Oswestry Disability Index (ODI) was used to determine the participants'
functional status. The ODI was developed in 1976 by O'Brien and is a condition-specific
outcome measure used in the management of spinal disorders. The ODI has been broadly tested
and was found to have good psychometric properties and to be useful in a wide variety of
settings. The ODI is the 'gold standard' for low back functional outcome instruments, is
self-administered and consists of a 10-item questionnaire. The first section evaluates the
intensity of pain and the others describe its disabling effects on typical daily activities
including personal care activities (washing, dressing), lifting, walking, sitting, standing,
sleeping, social life and travelling. Each item is scored from 0 to 5, with higher values
demonstrating greater disability. The ODI's validity and reliability in the Turkish
population was examined by Yakut et al. (2004) and the Cronbach α value was reported as
0.91.
Exercise Level Exercise diaries are easy, cost-effective and frequently used methods to
measure physical activity. In this study, exercise diaries were used to determine the
exercise levels of participants in the intervention group. Exercise for 30 minutes at least
3 days a week was considered sufficient.
Ethical Considerations An Academy Ethical Committee approved the study design, protocols and
informed consent procedure with number 1491-348-11/1539-227. Participants were informed
about the study before inclusion and could decline to participate at any time. The
participants read and signed the informed consent form with the help of the nurse at the
beginning of the study.
Data Analysis Based on the intention-to-treat principle, all pregnant women were analyzed
according to the group they were assigned to, regardless of whether they received the
intervention or not. Missing data were not imputed. To investigate the differences between
the groups, the Student's t test was used for values with a normal distribution and the
Mann-Whitney U test was used for values without a normal distribution. To investigate the
differences within the groups, the paired samples t test was used for values with a normal
distribution and the Wilcoxon test was used for values without a normal distribution.
Repeated measurement results that did not have a normal distribution were analyzed using the
Friedman Test. The error level for all analysis was set at p = 0.05. The results were
analyzed using SPSS, version 15.0 (SPSS Inc., Chicago, IL, USA).
