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NCT Number: NCT07037316

Effect of PRE With LT Versus PRE 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

progressive resistance exercise with lymphatic taping

Diagnostic 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 Bandage

Diagnostic 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.

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Effect of Progressive Resistance Exercise With Lymphatic Taping Versus Progressive Resistance Exercise With Compression Bandages on Lymphedema in Pregnant Females

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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