Postpartum DisorderNCT05010837
Effect of KT Taping on Waist-to-hip Ratio, Abdominal Strength and Body Image Concerns in Postpartum Females.
A study testing Kinesio taping with abdominal exercises and Abdominal exercises in people with Postpartum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is aimed at determining the effect of kinesio taping on waist to hip ratio, abdominal muscle strength and body image concerns in postpartum females. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Disorder
- What is being tested?
- Kinesio taping with abdominal exercises and Abdominal exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prima parous females, eight weeks post-partum.
- Females with both vaginal delivery and C section.
Who cannot join
- Females who received previous abdominal or spinal surgeries.
- Females having infection in sutures.
- Females having abdominal hernia, skin sensitivity
- Females having moderate to severe Diastasis Recti (IRD more than 3 finger width).
- Neurological impairment affecting muscle performance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kinesio Taping on Waist-to-hip Ratio, Abdominal Muscle Strength and Body Image Concerns in Postpartum Females.
This study is aimed at determining the effect of kinesio taping on waist to hip ratio, abdominal muscle strength and body image concerns in postpartum females.
Read the detailed description
Post Caesarian section there is abdominal weakness and an increase in fat ratio. There is a significant decrease in strength of abdominal muscles and an increase in fat ratio after the C section. Common increase in abdominal circumference in postpartum females and its long term outcomes like women health orders change in body shape and dissatisfaction is arising very commonly in society. Body Image Concern Inventory scale is used to assess dysmorphic concern of body. This study will work on the effects of Kinesiotaping which will be easily applicable and increase muscle activation along with abdominal exercises to regain lost muscle strength and tightening of loose skin. This tapping technique has a therapeutic effect on muscles and easily available in the rehabilitation department. Nowadays it is becoming very common, easily available, and regarded by physiotherapists as a method to support, rehabilitate and stimulate some physiological processes. This study aims at determining rehabilitative treatment to reduce waist circumference in post partum females.
- Conditions
- Postpartum Disorder
- Being tested
- Kinesio taping with abdominal exercises, Abdominal exercises
- Keywords
- waist circumference, waist to hip ratio, body image, post partum, exercise
- Medical subject headings
- Puerperal Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio taping with abdominal exercisesOther
Experimental group was given kinesio taping along with abdominal exercises. Kinesio taping was applied in I-band technique. the first band is applied on rectus abdominis from origin to insertion starting from pubic symphysis till the xiphoid process. the second band is applied bilaterally on the left and right side external oblique muscles.
Abdominal exercises consist of 2-3 sets of 8 to 12 repetitions of head lift with bracing, head lift with pelvic tilt, pelvic clock, bridging, knee rolling and deep breathing exercises for 1 to 4 weeks.
From 5 to 8 weeks Same abdominal exercises with 5 sets and 15 to 20 repetitions were performed along with kinesio taping.
Abdominal exercisesOther
Abdominal exercises consist of 2-3 sets of 8 to 12 repetitions of head lift with bracing, head lift with pelvic tilt, pelvic clock, bridging, knee rolling and deep breathing exercises for 1 to 4 weeks.
From 5 to 8 weeks Same abdominal exercises with 5 sets and 15 to 20 repetitions were performed.
| Study group | Role | What they receive |
|---|---|---|
| Kinesio taping with abdominal exercises | Experimental | Kinesio taping will be applied along with abdominal exercises. Receives: Other: Kinesio taping with abdominal exercises |
| Abdominal Exercises | Active comparator | Only abdominal exercises will be administered to the participants. Receives: Other: Abdominal exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
waist to hip ratio
Changes from baseline waist circumference was measured using a non-elastic measuring tape was used perpendicular to the long axis of the body and horizontal to the floor at end of normal expiration at anatomic landmarks including midpoint between the lowest rib (below) and iliac crest (above). Hip Circumference was also measured around the largest parts of the hips. The waist-to-hip ratio was calculated by dividing the waist circumference by hip circumference. The scores were measured at baseline and after 8 weeks of intervention.
Measured: 8th week
Secondary outcomes (2)
Body Image concerns Inventory
changes from baseline Body image concerns were measured using body image concerns inventory. A brief questionnaire for assessment of dysmorphic concerns consisting of 19 points based on 5 points scale interpreting 1 never and 5 always. This scale indicates concerns relating to appearance, behavior, and social attitude. A highly useful, precise, and less time taking assessment regarding body concerns. Scores range from 19 to 95. where higher scores represent higher level of dysmorphic concerns.
Measured: 8th week
Double leg lowering test
Changes from baseline double leg lowering test was used to assess abdominal strength. Participant lies supine with arms across chest, examiner raises patients lower leg vertically, procedure will be explained. Blood pressure cuff placed at pelvis level inflated at 40 mmHg. Participants instructed to lower both legs with the extended knee from the vertical position down while keeping the pelvis in the posterior tilting position, and the pressure cuff used as feedback to try to maintain the starting inflated pressure. During the test if the pressure on the cuff reduces the test is stopped and the angle is measured using goniometer from table. the strength is graded as poor for 75-90 degree from table, fair (3) for 46-75 degree from the table, Good (4) 16-45 degrees from the table and Normal (5/5) 0-15 degrees from the table
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start30 Aug 2021
- Primary completion28 Feb 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Postpartum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ehsan, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010837
- Sponsor's protocol ID
- TehreemJabir
- Status last verified
- Apr 2022
- First submitted
- 11 Aug 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohamed H, Yousef A, Kamel HE, Oweda K, Abdelsameaa G. Kinesio Taping and Strength Recovery of Postnatal Abdominal Muscles after Cesarean Section. Egyptian Journal of Physical Therapy 2020 Dec 15; 4(1):13-9.
AcharryN, Kutty RK. Abdominal exercise with bracing, a therapeutic efficacy in reducing diastasis-recti among postpartum females Int J Physiother Res. 2015; (2):999-1005.
Dave H, AratiMahishale MP. Effect of Structured Abdominal Exercise Programme on Diastasis of Rectus Abdominis Muscle in Postpartum Women-An Experimental Study (Doctoral dissertation, KLE University, Belagavi, Karnataka)
Madly MM. Effect of Kinesio taping therapy on waist circumferences in postpartum women Journal of Medicine in Scientific Research. 2018 Jan 1; 1(1):4
Gursen C, Inanoglu D, Kaya S, Akbayrak T, Baltaci G. Effects of exercise and Kinesio taping on abdominal recovery in women with cesarean section: a pilot randomized controlled trial. Arch Gynecol Obstet. 2016 Mar;293(3):557-65. doi: 10.1007/s00404-015-3862-3. Epub 2015 Sep 2.
PubMed 26329802Vispute SS, Smith JD, LeCheminant JD, Hurley KS. The effect of abdominal exercise on abdominal fat. J Strength Cond Res. 2011 Sep;25(9):2559-64. doi: 10.1519/JSC.0b013e3181fb4a46.
PubMed 21804427El-Mekawy HS, Eldeeb AM, El-Lythy MA, El-Begawy AF. Effect of abdominal exercises versus abdominal supporting belt on post-partum abdominal efficiency and rectus separation. InProceedings of World Academy of Science, Engineering and Technology 2013 Jan 1 (No. 73, p. 742). World Academy of Science, Engineering and Technology (WASET).
Ghadakzadeh S, Ghazipour A, Khajeddin N, Karimian N, Borhani M. Body Image Concern Inventory (BICI) for identifying patients with BDD seeking rhinoplasty: using a Persian (Farsi) version. Aesthetic Plast Surg. 2011 Dec;35(6):989-94. doi: 10.1007/s00266-011-9718-8. Epub 2011 Apr 14.
PubMed 21491168Schulte-van Maaren YW, Giltay EJ, van Hemert AM, Zitman FG, de Waal MW, Van Rood YR, Carlier IV. Reference values for the Body Image Concern Inventory (BICI), the Whitely Index (WI), and the Checklist Individual Strength (CIS-20R): The Leiden Routine Outcome Monitoring Study. J Affect Disord. 2014 Aug;164:82-9. doi: 10.1016/j.jad.2014.03.013. Epub 2014 Mar 24.
PubMed 24856558Ptak A, Konieczny G, Stefanska M. The influence of short-term kinesiology taping on force-velocity parameters of the rectus abdominis muscle. J Back Musculoskelet Rehabil. 2013;26(3):291-7. doi: 10.3233/BMR-130382.
PubMed 23893144Littleton HL, Axsom D, Pury CL. Development of the body image concern inventory. Behav Res Ther. 2005 Feb;43(2):229-41. doi: 10.1016/j.brat.2003.12.006.
PubMed 15629752Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.
PubMed 24268942Fu TC, Wong AM, Pei YC, Wu KP, Chou SW, Lin YC. Effect of Kinesio taping on muscle strength in athletes-a pilot study. J Sci Med Sport. 2008 Apr;11(2):198-201. doi: 10.1016/j.jsams.2007.02.011. Epub 2007 Jun 27.
PubMed 17588814El-Refaye GE, El Nahas EM, Ghareeb HO. Effect of kinesio taping therapy combined with breathing exercises on childbirth duration and labor pain: a randomized controlled trial. Bulletin of Faculty of Physical Therapy 2016 Jun; 21(1):23-31.
Krause DA, Youdas JW, Hollman JH, Smith J. Abdominal muscle performance as measured by the double leg-lowering test. Arch Phys Med Rehabil. 2005 Jul;86(7):1345-8. doi: 10.1016/j.apmr.2004.12.020.
PubMed 16003662
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Taping on Waist-to-hip Ratio, Abdominal Muscle Strength and Body Image Concerns in Postpartum Females.
- ClinicalTrials.gov ID
- NCT05010837
- Acronym / sponsor ID
- TehreemJabir
- Conditions
- Postpartum Disorder
- Keywords
- waist circumference, waist to hip ratio, body image, post partum, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed at determining the effect of kinesio taping on waist to hip ratio, abdominal muscle strength and body image concerns in postpartum females.
Detailed description
Post Caesarian section there is abdominal weakness and an increase in fat ratio. There is a significant decrease in strength of abdominal muscles and an increase in fat ratio after the C section. Common increase in abdominal circumference in postpartum females and its long term outcomes like women health orders change in body shape and dissatisfaction is arising very commonly in society. Body Image Concern Inventory scale is used to assess dysmorphic concern of body. This study will work on the effects of Kinesiotaping which will be easily applicable and increase muscle activation along with abdominal exercises to regain lost muscle strength and tightening of loose skin. This tapping technique has a therapeutic effect on muscles and easily available in the rehabilitation department. Nowadays it is becoming very common, easily available, and regarded by physiotherapists as a method to support, rehabilitate and stimulate some physiological processes. This study aims at determining rehabilitative treatment to reduce waist circumference in post partum females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesio taping with abdominal exercises | Experimental | Other: Kinesio taping with abdominal exercisesKinesio taping will be applied along with abdominal exercises. |
| Abdominal Exercises | Active comparator | Other: Abdominal exercisesOnly abdominal exercises will be administered to the participants. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Prima parous females, eight weeks post-partum.
- Females with both vaginal delivery and C section.
Key exclusion criteria (5 listed)
- Females who received previous abdominal or spinal surgeries.
- Females having infection in sutures.
- Females having abdominal hernia, skin sensitivity
- Females having moderate to severe Diastasis Recti (IRD more than 3 finger width).
- Neurological impairment affecting muscle performance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio taping with abdominal exercisesExperimental group was given kinesio taping along with abdominal exercises. Kinesio taping was applied in I-band technique. the first band is applied on rectus abdominis from origin to insertion starting from pubic symphysis till the xiphoid process. the second band is applied bilaterally on the left and right side external oblique muscles. Abdominal exercises consist of 2-3 sets of 8 to 12 repetitions of head lift with bracing, head lift with pelvic tilt, pelvic clock, bridging, knee rolling and deep breathing exercises for 1 to 4 weeks. From 5 to 8 weeks Same abdominal exercises with 5 sets and 15 to 20 repetitions were performed along with kinesio taping. | Other | Kinesio taping with abdominal exercises |
| Abdominal exercisesAbdominal exercises consist of 2-3 sets of 8 to 12 repetitions of head lift with bracing, head lift with pelvic tilt, pelvic clock, bridging, knee rolling and deep breathing exercises for 1 to 4 weeks. From 5 to 8 weeks Same abdominal exercises with 5 sets and 15 to 20 repetitions were performed. | Other | Abdominal Exercises |
Primary outcome
waist to hip ratio
Time frame: 8th week
Changes from baseline waist circumference was measured using a non-elastic measuring tape was used perpendicular to the long axis of the body and horizontal to the floor at end of normal expiration at anatomic landmarks including midpoint between the lowest rib (below) and iliac crest (above). Hip Circumference was also measured around the largest parts of the hips. The waist-to-hip ratio was calculated by dividing the waist circumference by hip circumference. The scores were measured at baseline and after 8 weeks of intervention.
2 secondary outcomes
Body Image concerns Inventory
Time frame: 8th week
Double leg lowering test
Time frame: 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- BackgroundMohamed H, Yousef A, Kamel HE, Oweda K, Abdelsameaa G. Kinesio Taping and Strength Recovery of Postnatal Abdominal Muscles after Cesarean Section. Egyptian Journal of Physical Therapy 2020 Dec 15; 4(1):13-9.
- BackgroundAcharryN, Kutty RK. Abdominal exercise with bracing, a therapeutic efficacy in reducing diastasis-recti among postpartum females Int J Physiother Res. 2015; (2):999-1005.
- BackgroundDave H, AratiMahishale MP. Effect of Structured Abdominal Exercise Programme on Diastasis of Rectus Abdominis Muscle in Postpartum Women-An Experimental Study (Doctoral dissertation, KLE University, Belagavi, Karnataka)
- BackgroundMadly MM. Effect of Kinesio taping therapy on waist circumferences in postpartum women Journal of Medicine in Scientific Research. 2018 Jan 1; 1(1):4
- Background: PubMed 26329802Gursen C, Inanoglu D, Kaya S, Akbayrak T, Baltaci G. Effects of exercise and Kinesio taping on abdominal recovery in women with cesarean section: a pilot randomized controlled trial. Arch Gynecol Obstet. 2016 Mar;293(3):557-65. doi: 10.1007/s00404-015-3862-3. Epub 2015 Sep 2.
- Background: PubMed 21804427Vispute SS, Smith JD, LeCheminant JD, Hurley KS. The effect of abdominal exercise on abdominal fat. J Strength Cond Res. 2011 Sep;25(9):2559-64. doi: 10.1519/JSC.0b013e3181fb4a46.
- BackgroundEl-Mekawy HS, Eldeeb AM, El-Lythy MA, El-Begawy AF. Effect of abdominal exercises versus abdominal supporting belt on post-partum abdominal efficiency and rectus separation. InProceedings of World Academy of Science, Engineering and Technology 2013 Jan 1 (No. 73, p. 742). World Academy of Science, Engineering and Technology (WASET).
- Background: PubMed 21491168Ghadakzadeh S, Ghazipour A, Khajeddin N, Karimian N, Borhani M. Body Image Concern Inventory (BICI) for identifying patients with BDD seeking rhinoplasty: using a Persian (Farsi) version. Aesthetic Plast Surg. 2011 Dec;35(6):989-94. doi: 10.1007/s00266-011-9718-8. Epub 2011 Apr 14.
- Background: PubMed 24856558Schulte-van Maaren YW, Giltay EJ, van Hemert AM, Zitman FG, de Waal MW, Van Rood YR, Carlier IV. Reference values for the Body Image Concern Inventory (BICI), the Whitely Index (WI), and the Checklist Individual Strength (CIS-20R): The Leiden Routine Outcome Monitoring Study. J Affect Disord. 2014 Aug;164:82-9. doi: 10.1016/j.jad.2014.03.013. Epub 2014 Mar 24.
- Background: PubMed 23893144Ptak A, Konieczny G, Stefanska M. The influence of short-term kinesiology taping on force-velocity parameters of the rectus abdominis muscle. J Back Musculoskelet Rehabil. 2013;26(3):291-7. doi: 10.3233/BMR-130382.
- Background: PubMed 15629752Littleton HL, Axsom D, Pury CL. Development of the body image concern inventory. Behav Res Ther. 2005 Feb;43(2):229-41. doi: 10.1016/j.brat.2003.12.006.
- Background: PubMed 24268942Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Ehsan, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping with abdominal exercises and Abdominal exercises in people with Postpartum Disorder, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waist to hip ratio (time frame: 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05010837, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.