LymphedemaNCT07037316
Effect of PRE With LT Versus PRE With Compression Bandages on Lymphedema in Pregnant Females
A study testing progressive resistance exercise with lymphatic taping and progressive resistance exercise with compression Bandage in people with Lymphedema, run by Superior University at 1 site in Pakistan.
Trial summary
This Study aims to compare the effectiveness of progressive resistance exercise (PRE) combined with lymphatic taping versus PRE combined with compression bandaging in managing lower limb lymphedema in pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- progressive resistance exercise with lymphatic taping and progressive resistance exercise with compression Bandage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pregnant females aged 18-40 years diagnosed with lymphedema.
- Nulliparous, primiparous, or multiparous pregnant females.
- resenting a sensation of heaviness, pain, swelling, and/or tingling in LL, with written authorization from their obstetrician.
- Ability to provide informed consent and comply with the treatment protocol.
Who cannot join
- pregnant women with some clinical instability, diagnosed with uncontrolled gestational hypertension, renal failure and deep vein thrombosis (DVT).
- Any Skin continuity, wound; dermatological, lymphatic, and cardiac diseases; infections; and voluminous and symptomatic varicose veins.
- High-risk pregnancy conditions such as placenta previa, preeclampsia, or any contraindications to exercise.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
Official title: Effect of Progressive Resistance Exercise With Lymphatic Taping Versus Progressive Resistance Exercise With Compression Bandages on Lymphedema in Pregnant Females
This Study aims to compare the effectiveness of progressive resistance exercise (PRE) combined with lymphatic taping versus PRE combined with compression bandaging in managing lower limb lymphedema in pregnant women. Lymphedema during pregnancy is often caused by hormonal and mechanical changes that lead to fluid retention and swelling, significantly affecting mobility and quality of life. The study will involve 59 pregnant women diagnosed with lymphedema, divided into two groups.
Read the detailed description
Both groups will follow a supervised PRE program, with one group receiving lymphatic kinesio taping and the other receiving compression bandaging as adjunct treatments. Outcomes will be assessed using the Visual Analog Scale (VAS) for pain, Borg scale for exertion, and Disability Rating Index for functional limitations. Data will be collected at baseline, week 4, and week 8.
- Conditions
- Lymphedema
- Being tested
- progressive resistance exercise with lymphatic taping, progressive resistance exercise with compression Bandage
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive resistance exercise with lymphatic tapingDiagnostic test
Participants will receive a supervised, moderate-to-vigorous intensity resistance training program designed specifically for pregnant women, The resistance training will involve the use of light barbells (1-10 lbs) and weight plates (2.5-10 lbs), targeting all major muscle groups through 50-80 repetitions per muscle group over 3-5 minutes, with short rest intervals. Exercises will be performed at a self-rated intensity level considered moderate to vigorous, following the Borg scale for perceived exertion. The training program is based on the BodyPump format but modified to suit pregnancy-related safety considerations.
progressive resistance exercise with compression BandageDiagnostic test
Participants in will receive progressive resistance exercise same as Group B and also receive thecompression bandaging as the primary intervention for the management of lower-limb oedema during pregnancy. The compression bandage will be applied in a multi-layered manner, beginning from the base of the toes and extending proximally to below the knee, ensuring graded pressure with higher compression distally and gradually reducing proximally to support venous and lymphatic return. Prior to each application, participants will be asked to lie in a supine position with their legs elevated for 15-20 minutes to reduce pre-existing swelling.
| Study group | Role | What they receive |
|---|---|---|
| progressive resistance exercise with lymphatic taping | Experimental | Not described Receives: Diagnostic Test: progressive resistance exercise with lymphatic taping |
| progressive resistance exercise with compression Bandage | Experimental | Not described Receives: Diagnostic Test: progressive resistance exercise with compression Bandage |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS)
A visual analog scale (VAS) score is determined by measuring the distance on a line, usually 10 centimeters long, where one end represents "no pain" and the other "worst pain
Measured: 6 Month
Disability Rating Index (DRI)
The Disability Rating Index (DRI) is a tool used to assess the level of physical disability, with scores ranging from 0 to 100. A score of 0 represents normal function, while 100 indicates complete disability, according to ResearchGate. The Disability Rating Scale (DRS) is another measure, particularly for individuals with traumatic brain injuries, with scores ranging from 0 to 29, where higher scores indicate greater impairment
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start4 Mar 2025
- Primary completion1 Jun 2025
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037316
- Sponsor's protocol ID
- DPT/Batch-Fall20/1011
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Resistance Exercise With Lymphatic Taping Versus Progressive Resistance Exercise With Compression Bandages on Lymphedema in Pregnant Females
- ClinicalTrials.gov ID
- NCT07037316
- Acronym / sponsor ID
- DPT/Batch-Fall20/1011
- Conditions
- Lymphedema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 25 Jun 2025 (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 aims to compare the effectiveness of progressive resistance exercise (PRE) combined with lymphatic taping versus PRE combined with compression bandaging in managing lower limb lymphedema in pregnant women. Lymphedema during pregnancy is often caused by hormonal and mechanical changes that lead to fluid retention and swelling, significantly affecting mobility and quality of life. The study will involve 59 pregnant women diagnosed with lymphedema, divided into two groups.
Detailed description
Both groups will follow a supervised PRE program, with one group receiving lymphatic kinesio taping and the other receiving compression bandaging as adjunct treatments. Outcomes will be assessed using the Visual Analog Scale (VAS) for pain, Borg scale for exertion, and Disability Rating Index for functional limitations. Data will be collected at baseline, week 4, and week 8.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progressive resistance exercise with lymphatic taping | Experimental | Diagnostic Test: progressive resistance exercise with lymphatic taping |
| progressive resistance exercise with compression Bandage | Experimental | Diagnostic Test: progressive resistance exercise with compression Bandage |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant females aged 18-40 years diagnosed with lymphedema.
- Nulliparous, primiparous, or multiparous pregnant females.
- resenting a sensation of heaviness, pain, swelling, and/or tingling in LL, with written authorization from their obstetrician.
- Ability to provide informed consent and comply with the treatment protocol.
Key exclusion criteria (3 listed)
- pregnant women with some clinical instability, diagnosed with uncontrolled gestational hypertension, renal failure and deep vein thrombosis (DVT).
- Any Skin continuity, wound; dermatological, lymphatic, and cardiac diseases; infections; and voluminous and symptomatic varicose veins.
- High-risk pregnancy conditions such as placenta previa, preeclampsia, or any contraindications to exercise.
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 |
|---|---|---|
| progressive resistance exercise with lymphatic tapingParticipants will receive a supervised, moderate-to-vigorous intensity resistance training program designed specifically for pregnant women, The resistance training will involve the use of light barbells (1-10 lbs) and weight plates (2.5-10 lbs), targeting all major muscle groups through 50-80 repetitions per muscle group over 3-5 minutes, with short rest intervals. Exercises will be performed at a self-rated intensity level considered moderate to vigorous, following the Borg scale for perceived exertion. The training program is based on the BodyPump format but modified to suit pregnancy-related safety considerations. | Diagnostic test | progressive resistance exercise with lymphatic taping |
| progressive resistance exercise with compression BandageParticipants in will receive progressive resistance exercise same as Group B and also receive thecompression bandaging as the primary intervention for the management of lower-limb oedema during pregnancy. The compression bandage will be applied in a multi-layered manner, beginning from the base of the toes and extending proximally to below the knee, ensuring graded pressure with higher compression distally and gradually reducing proximally to support venous and lymphatic return. Prior to each application, participants will be asked to lie in a supine position with their legs elevated for 15-20 minutes to reduce pre-existing swelling. | Diagnostic test | progressive resistance exercise with compression Bandage |
Primary outcome
visual analog scale (VAS)
Time frame: 6 Month
A visual analog scale (VAS) score is determined by measuring the distance on a line, usually 10 centimeters long, where one end represents "no pain" and the other "worst pain
Disability Rating Index (DRI)
Time frame: 6 Months
The Disability Rating Index (DRI) is a tool used to assess the level of physical disability, with scores ranging from 0 to 100. A score of 0 represents normal function, while 100 indicates complete disability, according to ResearchGate. The Disability Rating Scale (DRS) is another measure, particularly for individuals with traumatic brain injuries, with scores ranging from 0 to 29, where higher scores indicate greater impairment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive resistance exercise with lymphatic taping and progressive resistance exercise with compression Bandage in people with Lymphedema, run by Superior 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
visual analog scale (VAS) (time frame: 6 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2025.