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Clinical Trials/NCT07037316
NCT07037316Active, not recruitingNot Applicable

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

Superior University1 site in 1 country59 target enrollmentStarted: March 4, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
59
Locations
1
Primary Endpoint
visual analog scale (VAS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

progressive resistance exercise with lymphatic taping

Experimental

Intervention: progressive resistance exercise with lymphatic taping (Diagnostic Test)

progressive resistance exercise with compression Bandage

Experimental

Intervention: progressive resistance exercise with compression Bandage (Diagnostic Test)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammad Naveed Babur

Principal Investigator

Superior University

Study Sites (1)

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