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

Sponsor
Biruni University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05650372
Collaborator
Istanbul University (Other)
36
1
2
3
11.9

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Other: High intensity resistive exercise
  • Other: Low intensity resistive exercise
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled single-blind studyRandomized controlled single-blind study
Masking:
Single (Outcomes Assessor)
Masking Description:
The assessor will be blind to the randomization and the investigator will be blind to the outcomes
Primary Purpose:
Treatment
Official Title:
Comparison Of The Efficiency Of High Intensity And Low Intensity Resistive Exercises In Patient With Upper Extremity Lymphedema
Actual Study Start Date :
Nov 15, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: High intensity resistive exercise group

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.

Other: High intensity resistive exercise
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.

Active Comparator: Low intensity resistive exercise group

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.

Other: Low intensity resistive exercise
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.

Outcome Measures

Primary Outcome Measures

  1. Arm circumference measurement [1 month]

    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

  1. Measure of grip strength [1 month]

    Grip strength on the affected extremity will be measured with a jamar dynamometer.

  2. Evaluation of pain (McGill Pain Questionnaire) [1 month]

    The mcgill Pain Questionnaire (MPQ) 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 MPQ 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.

  3. The disabilities of the arm, shoulder and hand (DASH) questionnaire [1 month]

    Assess musculoskeletal disorders of the upper limbs will be measured the DASH. The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.

  4. Lymphedema Life Impact Scale [1 month]

    Lymphedema Life Impact Scale was developed as a comprehensive,lymphedema-specific instrument to assessthe effects of lymphedema in any extremity.The LLIS is an 18-item measure of physical,psychosocial, and functional impairmentscaused by lymphedema.

  5. Lymphedema Symptom Severity Scale [1 month]

    Subjective feeling of heaviness, swelling and tension intensity will be measured using a visual analog scale (VAS).

  6. Pinch Strength Test [1 month]

    This evaulation for measure 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 pinchmeter

  7. Lymphedema Functioning, Disability and Health Questionnaire/Lymph-Icf [1 month]

    The lymph-ıcf 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul University Istanbul Fatih Turkey 34093

Sponsors and Collaborators

  • Biruni University
  • Istanbul University

Investigators

  • Study Chair: Buket Akinci, PT, PhD, Biruni University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Buket AKINCI, Assoc. Prof., Biruni University
ClinicalTrials.gov Identifier:
NCT05650372
Other Study ID Numbers:
  • 2015-KAEK-64-22-09
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Buket AKINCI, Assoc. Prof., Biruni University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2022