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

NCT ID: NCT07037316

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

progressive resistance exercise with lymphatic taping

Group Type: EXPERIMENTAL

progressive resistance exercise with lymphatic taping

Intervention Type: 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

Group Type: EXPERIMENTAL

progressive resistance exercise with compression Bandage

Intervention Type: 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.

Interventions

progressive resistance exercise with lymphatic taping

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.

Intervention Type: DIAGNOSTIC_TEST

progressive resistance exercise with compression Bandage

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

DPT/Batch-Fall20/1011

Identifier Type: -

Identifier Source: org_study_id