Effect of PRE With LT Versus PRE With Compression Bandages on Lymphedema in Pregnant Females

NCT07037316 | Active Not Recruiting DMC

• 1 other identifier: DPT/Batch-Fall20/1011
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (2)

• 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

  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

  6 Months

Study Arms (2)

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

Interventions

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 lymphatic taping

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.

progressive resistance exercise with compression Bandage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

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

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: March 4, 2025
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)