Diastasis RectiNCT05811299
Effects of Abdominal Exercises and Kinesio Taping on Abdominal Strength in Females With Diastasis Recti.
A study testing Kinesio taping and Abominal exercises in people with Diastasis Recti and Kinesio Taping, run by Riphah International University at 1 site in Pakistan.
Trial summary
Diastasis recti is an increase in the gap between the rectus abdominis muscles at the midline caused by anterior abdominal wall weakening. The aim of this study is to evaluate the effects of abdominal exercises with and without Kinesio taping on abdominal strength of females with diastasis recti for their better… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diastasis Recti, Kinesio Taping
- What is being tested?
- Kinesio taping and Abominal exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2022to 1 Aug 2023
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post natal till 6 months
- Rectus abdominis diastasis > 2.7 cm at umbilicus
- Age 18 to 40
Who cannot join
- Pregnant female
- Hernia
- Females with physical and mental illness
- Females with any other medical condition like cardiorespiratory diseases
- History of malignancy
- Urogynecologic disorders
- Females suffering from other gynecological issues such as endometriosis
- Polycystic ovaries syndrome
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Jinnah Hospital,Gynae department
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Abdominal Exercises With and Without Kinesio Taping on Abdominal Strength and Quality of Life in Females With Diastasis Recti.
Diastasis recti is an increase in the gap between the rectus abdominis muscles at the midline caused by anterior abdominal wall weakening. The aim of this study is to evaluate the effects of abdominal exercises with and without Kinesio taping on abdominal strength of females with diastasis recti for their better quality of life. This study will be randomized controlled trial .Subjects with diastasis recti meeting the predetermined inclusion and exclusion criteria will be requested to participate in the study via informed consent. Non probability convenient sampling technique will be used. 46 participants will be randomly allocated to either Group A or Group B .Group A will be treated with Kinesio Taping applied in a criss -cross design for consecutive 3 days with 1 day gap after taping will do abdominal exercises.Group B will be treated with above mentioned abdominal exercises for 1 month. Pre and post assessment of diastasis recti and abdominal strength will be done using caliper method and manual muscle test and quality of life will be assessed by MAPP-QOL questionnaire.Jinnah Hospital will be the setting and SPSS software will be used.
Read the detailed description
Diastasis recti is an increase in the gap between the rectus abdominis muscles at the midline caused by anterior abdominal wall weakening. Diastasis recti abdominis is most common in the female population during pregnancy and after childbirth. The abdominals are stretched as your uterus expands during pregnancy, and the linea alba thins and pulls apart causes the rectus abdominis muscles to split during pregnancy. The aim of this study is to evaluate the effects of abdominal exercises with and without Kinesio taping on abdominal strength of females with diastasis recti for their better quality of life.
This study will be randomized controlled trial .Subjects with diastasis recti meeting the predetermined inclusion and exclusion criteria will be requested to participate in the study via informed consent. Non probability convenient sampling technique will be used. 46 participants will be randomly allocated to either Group A or Group B via lottery method.Subjects in Group A will be treated with Kinesio Taping applied in a criss -cross design for consecutive 3 days with 1 day gap after taping will do abdominal exercises which consists of abdominal crunch exercise ,Curl up,abdominal isometric contractions ,posterior pelvic tilt ,bridging. perform these exercises twice a week for 10 repititions for 1 month . Group B will be treated with above mentioned abdominal exercises for 1 month. Pre and post assessment of diastasis recti and abdominal strength will be done using caliper method and manual muscle test and quality of life will be assessed by MAPP-QOL questionnaire. Data will be collected from Jinnah Hospital Lahore.The data collected will be analyzed using SPSS 25.
- Conditions
- Diastasis Recti, Kinesio Taping
- Being tested
- Kinesio taping, Abominal exercises
- Keywords
- Childbirth, Isometric Contractions, Kinesio Tape, Postpartum Women, Rectus Abdominus.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
Total of 8 sessions for 4 weeks 2 sessions in a week.
Abominal exercisesOther
Total of 8 sessions for 4 weeks 2 sessions in a week.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Exercises and KT intervention | Experimental | (Group A ) will receive kinesio taping with abdominal exercises. 8 sessions for 4 weeks and 2 session will be given in a week. Receives: Other: Kinesio taping; Other: Abominal exercises |
| Abdominal exercises | Active comparator | (Group B) will receive abdominal exercises 8 sessions for 4 weeks and 2 session will be given in a week. Receives: Other: Abominal exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caliper Method
Rectus abdominis diastasis will be measured during the postpartum period with a high degree of reliability when a dial callper is used.
Measured: 4 weeks
MMT
Manual muscle testing (MMT) based on a grading system of 0 to 5.To check the abdminal strength
Measured: 4weeks
MAPP QOL
The Maternal Postpartum Quality of Life (MAPP-QOL) instrument consisted of 41 item to check quality of life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start20 Nov 2022
- Primary completion30 Jul 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, Mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811299
- Sponsor's protocol ID
- REC/RCR&AHS/23/0503
- Status last verified
- Dec 2023
- First submitted
- 31 Mar 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 26329802Gluppe SB, Engh ME, Bo K. Immediate Effect of Abdominal and Pelvic Floor Muscle Exercises on Interrecti Distance in Women With Diastasis Recti Abdominis Who Were Parous. Phys Ther. 2020 Aug 12;100(8):1372-1383. doi: 10.1093/ptj/pzaa070.
PubMed 32302393Radhakrishnan M, Ramamurthy K. Efficacy and Challenges in the Treatment of Diastasis Recti Abdominis-A Scoping Review on the Current Trends and Future Perspectives. Diagnostics (Basel). 2022 Aug 24;12(9):2044. doi: 10.3390/diagnostics12092044.
PubMed 36140446Boxer S, Jones S. Intra-rater reliability of rectus abdominis diastasis measurement using dial calipers. Aust J Physiother. 1997;43(2):109-114. doi: 10.1016/s0004-9514(14)60405-0.
PubMed 11676678
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Exercises With and Without Kinesio Taping on Abdominal Strength and Quality of Life in Females With Diastasis Recti.
- ClinicalTrials.gov ID
- NCT05811299
- Acronym / sponsor ID
- REC/RCR&AHS/23/0503
- Conditions
- Diastasis Recti, Kinesio Taping
- Keywords
- Childbirth, Isometric Contractions, Kinesio Tape, Postpartum Women, Rectus Abdominus.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 13 Apr 2023 (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.
Diastasis recti is an increase in the gap between the rectus abdominis muscles at the midline caused by anterior abdominal wall weakening. The aim of this study is to evaluate the effects of abdominal exercises with and without Kinesio taping on abdominal strength of females with diastasis recti for their better quality of life. This study will be randomized controlled trial .Subjects with diastasis recti meeting the predetermined inclusion and exclusion criteria will be requested to participate in the study via informed consent. Non probability convenient sampling technique will be used. 46 participants will be randomly allocated to either Group A or Group B .Group A will be treated with Kinesio Taping applied in a criss -cross design for consecutive 3 days with 1 day gap after taping will do abdominal exercises.Group B will be treated with above mentioned abdominal exercises for 1 month. Pre and post assessment of diastasis recti and abdominal strength will be done using caliper method and manual muscle test and quality of life will be assessed by MAPP-QOL questionnaire.Jinnah Hospital will be the setting and SPSS software will be used.
Detailed description
Diastasis recti is an increase in the gap between the rectus abdominis muscles at the midline caused by anterior abdominal wall weakening. Diastasis recti abdominis is most common in the female population during pregnancy and after childbirth. The abdominals are stretched as your uterus expands during pregnancy, and the linea alba thins and pulls apart causes the rectus abdominis muscles to split during pregnancy. The aim of this study is to evaluate the effects of abdominal exercises with and without Kinesio taping on abdominal strength of females with diastasis recti for their better quality of life.
This study will be randomized controlled trial .Subjects with diastasis recti meeting the predetermined inclusion and exclusion criteria will be requested to participate in the study via informed consent. Non probability convenient sampling technique will be used. 46 participants will be randomly allocated to either Group A or Group B via lottery method.Subjects in Group A will be treated with Kinesio Taping applied in a criss -cross design for consecutive 3 days with 1 day gap after taping will do abdominal exercises which consists of abdominal crunch exercise ,Curl up,abdominal isometric contractions ,posterior pelvic tilt ,bridging. perform these exercises twice a week for 10 repititions for 1 month . Group B will be treated with above mentioned abdominal exercises for 1 month. Pre and post assessment of diastasis recti and abdominal strength will be done using caliper method and manual muscle test and quality of life will be assessed by MAPP-QOL questionnaire. Data will be collected from Jinnah Hospital Lahore.The data collected will be analyzed using SPSS 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Exercises and KT intervention | Experimental | Other: Kinesio taping, Other: Abominal exercises(Group A ) will receive kinesio taping with abdominal exercises. 8 sessions for 4 weeks and 2 session will be given in a week. |
| Abdominal exercises | Active comparator | Other: Abominal exercises(Group B) will receive abdominal exercises 8 sessions for 4 weeks and 2 session will be given in a week. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Post natal till 6 months
- Rectus abdominis diastasis > 2.7 cm at umbilicus
- Age 18 to 40
Key exclusion criteria (8 listed)
- Pregnant female
- Hernia
- Females with physical and mental illness
- Females with any other medical condition like cardiorespiratory diseases
- History of malignancy
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 tapingTotal of 8 sessions for 4 weeks 2 sessions in a week. | Other | Abdominal Exercises and KT intervention |
| Abominal exercisesTotal of 8 sessions for 4 weeks 2 sessions in a week. | Other | Abdominal Exercises and KT intervention, Abdominal exercises |
Primary outcome
Caliper Method
Time frame: 4 weeks
Rectus abdominis diastasis will be measured during the postpartum period with a high degree of reliability when a dial callper is used.
MMT
Time frame: 4weeks
Manual muscle testing (MMT) based on a grading system of 0 to 5.To check the abdminal strength
MAPP QOL
Time frame: 4 weeks
The Maternal Postpartum Quality of Life (MAPP-QOL) instrument consisted of 41 item to check quality of life
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 27 Dec 2023.
- 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 32302393Gluppe SB, Engh ME, Bo K. Immediate Effect of Abdominal and Pelvic Floor Muscle Exercises on Interrecti Distance in Women With Diastasis Recti Abdominis Who Were Parous. Phys Ther. 2020 Aug 12;100(8):1372-1383. doi: 10.1093/ptj/pzaa070.
- Background: PubMed 36140446Radhakrishnan M, Ramamurthy K. Efficacy and Challenges in the Treatment of Diastasis Recti Abdominis-A Scoping Review on the Current Trends and Future Perspectives. Diagnostics (Basel). 2022 Aug 24;12(9):2044. doi: 10.3390/diagnostics12092044.
- Background: PubMed 11676678Boxer S, Jones S. Intra-rater reliability of rectus abdominis diastasis measurement using dial calipers. Aust J Physiother. 1997;43(2):109-114. doi: 10.1016/s0004-9514(14)60405-0.
- Individual participant dataSharing planned: No
Related trials for Diastasis Recti
Recruiting
Prospective One-Year Evaluation of the Safety and Effectiveness of an Investigator-Developed Rectus Abdominis Plication Technique in Abdominoplasty
Diastasis Recti Abdominis, Abdominal Wall Laxity
Recruiting
Effects of Corrective Versus Plank Exercises on Diastasis Recti
Diastasis Recti
Recruiting
Effects of Pilates and Progressive Prone Plank Exercises in Diastasis Recti
Diastasis Recti
Recruiting
Risk Factors and Exercise Effects on Abdominal Separation in Seniors
Diastasis Recti Abdominis (DRA), Aging
Active, not recruiting
Comparative Effects of Telerehabilitation Versus In-Person Core Stability Training in Postpartum Women
Postpartum, Diastasis Recti Abdominis (DRA)
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.
Sabiha Arshad, Mphill 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 and Abominal exercises in people with Diastasis Recti and Kinesio Taping, 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 3 inclusion and 8 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 27 Dec 2023. 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?
Caliper Method (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 NCT05811299, which also lists 4 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 27 Dec 2023.