Condition category
Signs and Symptoms
Date applied
02/03/2016
Date assigned
29/04/2016
Last edited
29/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lumbo Pelvic Pain (LPP) is a common problem among pregnant women and those that have given birth within the last year (postnatal). LPP may lead to sleep problems, depression, fatigue and anxiety, and a general inability to carry out activities that involve carrying or lifting. Various treatments have been used to reduce LPP in general including physical exercise although the effect of exercise programmes in treating back pain is yet to be fully understood among postnatal women. In any case, new mothers in many Asian countries, such as Taiwan, tend to reduce physical activity after birth in accordance with traditional practices. Mothers in Taiwan receive verbal advice on exercise to be followed in the postnatal period by health care professionals before their discharge from hospital. Most of the hospitals also provide the women with a leaflet containing details of an exercise programme to manage postpartum LPP commonly referred to as back pain. However, very little is known about the uptake of this exercise programme or its benefits for postnatal women. Technology has been increasingly used in health care to deliver various treatments and technology based delivery can improve the uptake of exercise among certain groups. How acceptable different methods of teaching the exercises, using digital or print media are and how they might affect how many postnatal women take up the exercise, adhere to it and complete an exercise programme has yet to be understood. Taiwan has a world-leading position in technology with 80% of all households owning personal computers and around 84% households with high speed internet connection. This study assesses the effectiveness of an exercise programme (the intervention) designed to strengthen abdominal and global muscles delivered using Digital Versatile Disc (DVD), Internet or leaflet, on LPP among postnatal women in Taiwan, and to compare exercise uptake, adherence and completion rates.

Who can participate?
Adult women (over 18) that are pregnant with their first baby (between 34-41 weeks gestation) and with LPP that was not present before they became pregnant.

What does the study involve?

Participants are randomly assigned into one of two intervention groups (DVD or Internet) or the control group (leaflet). Following the birth of their child, all participants are given the same exercise programme. The exercise program is developed for strengthening core abdominal and global muscles through abdominal muscle exercises, breathing exercises, head and neck exercises and leg exercises. The DVD group are given the exercise programme on a DVD. The Internet group are given access to YouTube videos playing the same content as the DVD. The leaflet group are given a description of the exercise programme in the form of a printed leaflet. All participants are asked to report on the severity of their LPP after three days, six weeks and finally 4 months after having given birth.

What are the possible benefits and risks of participating?
Expected benefits are a reduction in LPP pain and an improvement in the quality of life in the postnatal period. There may also be benefits for the healthcare system as decreased back pain and improved quality of life might result in fewer return visits to health services. The study will provide valuable information about the use of electronic means of delivery for health care interventions for women. This information can be used for the implementation of related future initiatives, not only in Taiwan but also globally.

Where is the study run from?
Shin Kong Medical Centre Hospital, Taipei (Taiwan)

When is study starting and how long is it expected to run for?
November 2014 to October 2016

Who is funding the study?
University of Bedfordshire (UK)

Who is the main contact?
1. Ms. Pei-Ching Tseng (public)
2. Dr. Shuby Puthussery (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Shuby Puthussery

ORCID ID

http://orcid.org/0000-0002-1865-9546

Contact details

University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom

Type

Public

Additional contact

Mrs Pei-Ching Tseng

ORCID ID

Contact details

University of Bedfordshire
Putteridge Bury
Hitchin Road
Luton
LU2 8LE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial to test the acceptability and effectiveness of multi-media delivery of an exercise programme among postpartum women with lumbo pelvic pain in Taiwan

Acronym

Study hypothesis

This study aims to assess the effectiveness of an exercise programme delivered using Digital Versatile Disc (DVD), Internet or leaflet, on LPP among postnatal women in Taiwan, and to compare exercise uptake, adherence and completion rate across three modes of delivery.

Ethics approval

1. Shin Kong Medical Centre Hospital Ethics Committee, Taiwan, 11/12/2014, ref: 20141005R
2. Institute for Health Research Ethics Committee at the University of Bedfordshire, 05/02/2015, ref: IHREC452

Study design

Pragmatic prospective single blinded, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lumbo pelvic pain (LPP)

Intervention

The intervention comprises of an exercise programme, designed to strengthen core abdominal and global muscles, recommended for postnatal women in Taiwan delivered through digital (DVD or Internet) or print (leaflet) media. The exercise program is designed to strengthen core abdominal and global muscles through abdominal muscle exercises, breathing exercises, head and neck exercises and leg exercises. The program consist of eight components intended to perform at various time points following birth. Women were instructed to perform the exercises twice a day for 30 minutes with outcomes measured at baseline, six weeks and four months follow-up.

Women are randomly assigned into two intervention groups (DVD and Internet) and a control group (leaflet). Women in the DVD-based group received the exercise program in a DVD along with narrations and demonstrations of the programme. The content of the DVD was posted on YouTube and women in the Internet group were provided with instructions on locating the video link on YouTube. Women in the control group received standard postnatal care which included the customary information given by their nurses along with the leaflet. All the participant women receive the same verbal instructions from the research midwife.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Change in LPP, measured using the Visual Analogue Scale (VAS) at 3 days, 6 weeks and 4 months postpartum

Secondary outcome measures

1. Physical endurance, measured using the Disability Rating Index (DRI)
2. Changes in core muscles, determined by physical examinations including measurements of waist circumference, body weight, and diastasis recti performed by a trained research midwife
3. Uptake
4. Adherence
5. Completion rate of exercise

Uptake, adherence and completion rate of exercise is using the self-record sheet. A self-record sheet is given to all the participants to record daily exercise frequency, duration and method of exercise. The record sheet also provided space to record reasons if not the exercise components were not followed as instructed.

All measured 3 days, 6 weeks and 4 months postpartum

Overall trial start date

01/11/2014

Overall trial end date

31/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant women who had LPP in the region of the lower back and/or anterior and/or posterior region of the pelvis and pain intensity on visual analogue scale (VAS) via self-report point on or over 30mm in the past week
2. Age > 18 years
3. Primipara and single-foetal pregnancy
4. No history of LPP before pregnancy
5. No history of perinatal complications for mother and baby
6. Planned vaginal delivery
7. Willing to provide informed consent for participation
8. Able to complete written forms in Mandarin

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

240

Participant exclusion criteria

1. History of clinician-reported contraindications for exercise
2. History of diagnosis of spinal problems before pregnancy
3. History of LPP before pregnancy
4. Pain intensity on visual analogue scale (VAS) via self-report point less than 30mm in the past week
5. History of perinatal complications
6. Birth (planned /actual) by caesarean section
7. Age< 18 years

Recruitment start date

01/03/2015

Recruitment end date

30/08/2016

Locations

Countries of recruitment

Taiwan

Trial participating centre

Shin Kong Wu Ho-Su Memorial Hospital
No. 95, Wenchang Rd Shilin District
Taipei City
111
Taiwan

Sponsor information

Organisation

University of Bedfordshire

Sponsor details

University Square
Luton
LU1 3JU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Bedfordshire (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We will disseminate the trial protocol and the findings through in peer reviewed journals and presentations at relevant conferences.

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes