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High Intensity vs Low Intensity Resistive Exercise In Patient With Upper Extremity Lymphedema

Primary Purpose

Lymphedema

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
High intensity resistive exercise
Low intensity resistive exercise
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring Lymphedema, Resistive Exercises

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Having been diagnosed with lymphedema of the upper extremity at least 6 months ago by the physician Having stage 2 lymphedema Having a circumference difference of 2-8 cm at any reference point between the affected extremity and the healthy extremity Being between the ages of 35-60 Volunteer to participate Not receiving lymphedema treatment in the last 6 months Exclusion Criteria: Having stage 1 or 3 lymphedema Have a greater than 8 cm less than 2 cm circumference difference any reference point between the affected extremity and the healthy extremity Papilloma, lymphedema or elephanthiasis with hyperkeratosis Have acute inflammatory diseases

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High intensity resistive exercise group

Low intensity resistive exercise group

Arm Description

Participants of this group will be applied manual lymphatic drainage and compression bandaging and they will exercise for 25 minutes, three sets of each exercise at 80% intensity of 1 max repetition.

Participants in this group will be applied manual lymphatic drainage and compression bandaging and they will exercise for 25 minutes, three sets of each exercise at 30% intensity of 1 max repetition.

Outcomes

Primary Outcome Measures

Arm circumference measurement
Bilateral arm circumference will be measured using a measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle.

Secondary Outcome Measures

Measure of grip strength
Grip strength on the affected extremity will be measured with a jamar dynamometer.
Evaluation of pain (McGill Pain Questionnaire)
The mcgill Pain Questionnaire is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The questionnaire is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain.
The disabilities of the arm, shoulder and hand (DASH) questionnaire
Assess musculoskeletal disorders of the upper limbs will be measured this questionnaire. The disabilities of the arm, shoulder, and hand questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
Lymphedema Life Impact Scale
Lymphedema Life Impact Scale was developed as a comprehensive,lymphedema-specific instrument to assess the effects of lymphedema on any extremity. The questionnaire is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.
Lymphedema Symptom Severity Scale
The subjective feeling of heaviness, swelling, and tension intensity will be measured using a visual analog scale.
Pinch Strength Test
This evaulation for measuring the maximum isometric strength of the hand and forearm muscles when doing a pinching action and pinch strength on the affected extremity will be measured with a pinch meter.
Lymphedema Functioning, Disability and Health Questionnaire
The Lymphedema Functioning, Disability, and Health Questionnaire is a reliable and valid questionnaire to assess impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema after axillary dissection for breast cancer.

Full Information

First Posted
December 6, 2022
Last Updated
February 7, 2023
Sponsor
Biruni University
Collaborators
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05650372
Brief Title
High Intensity vs Low Intensity Resistive Exercise In Patient With Upper Extremity Lymphedema
Official Title
Comparison Of The Efficiency Of High Intensity And Low Intensity Resistive Exercises In Patient With Upper Extremity Lymphedema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
Collaborators
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lymphedema results from impaired lymphatic transport with increased limb volume. The results of systematic reviews indicate that breast cancer survivors can perform resistance exercise training at high-enough intensities to elicit strength gains without triggering changes to lymphedema status. There is strong evidence indicating that ret produces significant gains in muscular strength without provoking breast cancer-related lymphedema. On the one hand, the literature studies say future exercise programs will have to be evaluated in detail regarding intensity, volume, duration, frequency, and exercised muscle group. The purpose of this study is to examine the impact of upper body resistance exercise on the arm circumference, grip strength, pain, musculoskeletal disorders of the upper limbs, self-reported lymphedema symptoms, pinch strength, lymphedema functioning, disability, and health questionnaire/lymph-ıcf patient with upper extremity lymphedema and to compare these effects between resistance exercise involving high and low loads (heavier vs lighter weights).
Detailed Description
Lymphedema results from impaired lymphatic transport with increased limb volume. Lymphedema is divided into primary and secondary forms. Secondary lymphedema is likely to occur after the surgical removal of lymph nodes or in conjunction with radiotherapy. Secondary lymphedema is generally described as arm swelling and dysfunction. It is defined as an increase in arm circumference by more than 2 cm or as an accumulation of excessive protein-rich liquid in a part of the body where lymphatic vessels have been damaged. Erysipelas (cellulitis) is the main complication, but psychological or functional discomfort may occur throughout the course of lymphedema. The associated swelling may range from mild to disabling and is associated with feelings of distress, heaviness, and weakness in the arm, pain, and an increased risk for infection. These symptoms further impair the functional and self-care abilities of the individuals, causing significant psychological distress and reduced quality of life. Upper-limb lymphedema secondary to breast cancer treatment is the most frequent. Lymphedema management is based on complete decongestive physiotherapy (multilayer low-stretch bandage, manual lymph drainage, skincare, and exercises). The American college of sports medicine (ACSM) roundtable on exercise guidelines for cancer survivors describes that exercise during and after cancer treatment is safe and can help patients improve their physical capacity and quality of life. The ACSM guidelines indicate specific exercise programs oriented towards impairments associated with disease and medical treatment. Strength exercise does not have any adverse effects on an existing to; instead, it has beneficial effects such as improvement of strength and lower exacerbation rates. For breast cancer survivors who develop lymphedema, resistance exercise has been demonstrated to improve symptom severity, strength, endurance, and mobility of the affected limb, without exacerbating lymphedema. Recent evidence indicates that resistance exercise training can be an effective management strategy for breast cancer-related lymphedema by improving functional capacity and lymph flow through the pumping effect stimulated by muscular contraction. The results of systematic reviews indicate that breast cancer survivors can perform resistance exercise training at high-enough intensities to elicit strength gains without triggering changes to lymphedema status. There is strong evidence indicating that ret produces significant improvements in muscular strength without provoking breast cancer-related lymphedema. On the one hand, the literature studies say future exercise programs will have to be evaluated in detail regarding intensity, volume, duration, frequency, and exercised muscle group. The purpose of this study is examine the impact of upper body resistance exercise on the arm circumference, grip strength, pain, musculoskeletal disorders of the upper limbs, self-reported lymphedema symptoms, pinch strength, lymphedema functioning, disability, and health questionnaire/lymph-ıcf patient with upper extremity lymphedema and to compare these effects between resistance exercise involving high and low loads (heavier vs lighter weights).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
Lymphedema, Resistive Exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled single-blind study
Masking
Outcomes Assessor
Masking Description
The assessor will be blind to the randomization and the investigator will be blind to the outcomes
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity resistive exercise group
Arm Type
Experimental
Arm Description
Participants of this group will be applied manual lymphatic drainage and compression bandaging and they will exercise for 25 minutes, three sets of each exercise at 80% intensity of 1 max repetition.
Arm Title
Low intensity resistive exercise group
Arm Type
Active Comparator
Arm Description
Participants in this group will be applied manual lymphatic drainage and compression bandaging and they will exercise for 25 minutes, three sets of each exercise at 30% intensity of 1 max repetition.
Intervention Type
Other
Intervention Name(s)
High intensity resistive exercise
Intervention Description
Participants of this group will be applied manual lymphatic drainage and compression bandaging every day of the week, and they will exercise for 25 minutes, three sets of each exercise at 80% intensity of 1 max repetition, 2 days of the week. Exercise training consist of warm-up and cool-down (10-15 repetitions of range of motion and 10 minutes of active stretching exercises) and resistive exercises.Each of the experimental sessions involved resistance exercises targeting all the major muscle groups in the upper body. Specifically, the exercises included the chest press, lat pull-down, bicep curl, triceps extension, lateral raise, and wrist curl.
Intervention Type
Other
Intervention Name(s)
Low intensity resistive exercise
Intervention Description
participants in this group will be applied manual lymphatic drainage and compression bandaging every day of the week and they will exercise for 25 minutes, three sets of each exercise at 30% intensity of 1 max repetition 2 days of the week. Exercise training consist of warm-up and cool-down (10-15 repetitions of range of motion and 10 minutes of active stretching exercises) and resistive exercises. Each of the experimental sessions involved resistance exercises targeting all the major muscle groups in the upper body. Specifically, the exercises included the chest press, lat pull- down, bicep curl, triceps extension, lateral raise, and wrist curl.
Primary Outcome Measure Information:
Title
Arm circumference measurement
Description
Bilateral arm circumference will be measured using a measuring tape at six reference points: the metacarpophalangeal joint, wrist joint, 10 and 15 cm distal to the lateral epicondyle, and 10 and 15 cm proximal to the lateral epicondyle.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Measure of grip strength
Description
Grip strength on the affected extremity will be measured with a jamar dynamometer.
Time Frame
1 month
Title
Evaluation of pain (McGill Pain Questionnaire)
Description
The mcgill Pain Questionnaire is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The questionnaire is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain.
Time Frame
1 month
Title
The disabilities of the arm, shoulder and hand (DASH) questionnaire
Description
Assess musculoskeletal disorders of the upper limbs will be measured this questionnaire. The disabilities of the arm, shoulder, and hand questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.
Time Frame
1 month
Title
Lymphedema Life Impact Scale
Description
Lymphedema Life Impact Scale was developed as a comprehensive,lymphedema-specific instrument to assess the effects of lymphedema on any extremity. The questionnaire is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.
Time Frame
1 month
Title
Lymphedema Symptom Severity Scale
Description
The subjective feeling of heaviness, swelling, and tension intensity will be measured using a visual analog scale.
Time Frame
1 month
Title
Pinch Strength Test
Description
This evaulation for measuring the maximum isometric strength of the hand and forearm muscles when doing a pinching action and pinch strength on the affected extremity will be measured with a pinch meter.
Time Frame
1 month
Title
Lymphedema Functioning, Disability and Health Questionnaire
Description
The Lymphedema Functioning, Disability, and Health Questionnaire is a reliable and valid questionnaire to assess impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema after axillary dissection for breast cancer.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having been diagnosed with lymphedema of the upper extremity at least 6 months ago by the physician Having stage 2 lymphedema Having a circumference difference of 2-8 cm at any reference point between the affected extremity and the healthy extremity Being between the ages of 35-60 Volunteer to participate Not receiving lymphedema treatment in the last 6 months Exclusion Criteria: Having stage 1 or 3 lymphedema Have a greater than 8 cm less than 2 cm circumference difference any reference point between the affected extremity and the healthy extremity Papilloma, lymphedema or elephanthiasis with hyperkeratosis Have acute inflammatory diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buket Akinci, PT, PhD
Organizational Affiliation
Biruni University
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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High Intensity vs Low Intensity Resistive Exercise In Patient With Upper Extremity Lymphedema

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